Anthony Strzalek
Synaptive announces US and Canadian availability of Modus X
Synaptive Medical has announced US Food and Drug Administration (FDA) registration of its next-generation robotic exoscope, Modus X.
Modus X, which is the fourth generation...
US Department of Defense grants University of Miami researcher $3.25 million...
Emad Ibrahim, director of the Male Fertility Research Program at The Miami Project to Cure Paralysis and the clinical andrology lab at the Desai...
Woven Orthopedic Technologies granted 510(k) clearance for Ogmend implant enhancement system
Woven Orthopedic Technologies has announced that its Ogmend implant enhancement system has received 510(k) clearance from the US Food and Drug Administration (FDA) for use...
Accelus announces FDA 510(k) clearance of Remi robotic navigation system for...
Accelus has announced that the US Food & Drug Administration (FDA) has issued it 510(k) clearance for its Remi robotic navigation system for use...
Porous 3D-printed interbody cages associated with lower rates of subsidence compared...
When considering interbody material for transforaminal lumbar interbody fusion (TLIF), both standard solid titanium (ST) and 3D-printed porous titanium (3DPT) cages perform well. However,...
Expanding Innovations bags FDA approval for X-PAC expandable lateral cage system
Expanding Innovations recently announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its X-PAC expandable lateral cage system (X-PAC LLIF).
The...
Neurosurgeons and orthopaedic spine surgeons provide similar results regardless of spine...
Despite significant data heterogeneity, a new systematic review and meta-analysis has shown that both neurosurgeons and orthopaedic spine surgeons have similar readmission, complication, and...
Risk factors for same-site recurrent disc herniation include smoking and preoperative...
Smoking and a higher preoperative disability are both independent risk factors for same-site recurrent disc herniation (sRDH), according to a new study which was...
First patient enrolled in trial comparing Nimbus radiofrequency ablation device to...
Stratus Medical has announced the first patient enrolled in the COBRA study, a double-blinded, randomised trial, comparing the bipolar treatment with Nimbus RF multitined...
INSPIRE 2.0 acute spinal cord injury study fails to achieve primary...
InVivo Therapeutics has announced topline results from the company’s INSPIRE 2.0 study, which was designed to evaluate the safety and probable benefit of InVivo’s...
NuVasive celebrates 20-year milestone of the XLIF procedure
NuVasive has, this week, announced the 20-year milestone achievement of its lateral lumbar procedure, extreme lateral interbody fusion (XLIF).
Ryan Donahoe, chief technology officer at...
Telemedicine satisfaction and usage remains high for spine patients post lockdown
The utilisation and satisfaction of telemedicine has remained high among spine patients, even after the easing of COVID-19 lockdown restrictions. This is according to...
New meta-analysis indicates no benefit of adding instrumented fusion to decompression...
There is no benefit of adding instrumented fusion to decompression for treating degenerative spondylolisthesis (DS), according to a recent systematic review and meta-analysis, the...
Surgeons fail to hit preoperative sagittal alignment goals in roughly a...
Surgeons failed to achieve their preoperative goal alignment of each sagittal parameter in approximately 25-30% of adult spinal deformity (ASD) patients and goal alignment...
Spinal News International’s top 10 most popular stories of February 2023
Research looking at the Vertebral Bone Quality Score as a predictor of pedicle screw loosening was our most viewed story in February, followed by...
TOPS facet joint replacement demonstrates significant improvements versus fusion in IDE...
Premia Spine has announced the publication of two-year outcomes from the TOPS facet joint replacement system’s clinical trial in the Journal of Neurosurgery Spine, which...
Restorative neurostimulation: A safe and effective therapy for patients with nonsurgical...
Christopher Gilligan, director of Brigham and Women’s Spine Service Line and associate chief medical officer of Brigham and Women’s Hospital (Boston, USA) talks to...
Aurora Spine receives IRB approval to commence multicentre study for DEXA-C...
Aurora Spine has announced that it has received Institutional Review Board (IRB) approval for its new multicentre study of its DEXA-C cervical interbody system,...
Xtant Medical acquires new product lines from Surgalign in US$17 million...
Xtant Medical has acquired the Coflex and Cofix product lines from Surgalign for a total consideration of US$17 million.
Coflex is an interlaminar stabilisation device used...
Is there too much of a conflict of interest between industry...
Is the relationship between industry and randomised controlled trials (RCTs) too cosy? Or instead, is it a vital relationship that can help drive improvements...
Ehlers-Danlos syndrome associated with higher medical and surgical complications following ACDF
Patients with Ehlers-Danlos syndrome (EDS) are at increased risk of both medical and surgical complications following anterior cervical discectomy and fusion (ACDF). As such,...
Increasing demand for posterior spinal fusion procedures will strain healthcare systems,...
The demand for posterior spinal fusion procedures is expected to increase by more than 80% by 2060. In addition, the demand will be even...
Combined flexion and compression negatively impact the mechanical integrity of the...
Static flexion, in combination with compression, negatively impacts the intralamellar and interlamellar matrix properties of the annulus fibrosus. This is the key finding of...
Centinel Spine announces 500th procedure with prodisc C Vivo and prodisc...
Centinel Spine has announced the completion of the 500th procedure in the USA with its latest US Food and Drug Administration (FDA)-approved total disc replacement...
Curiteva announces FDA 510(k) clearance for Inspire 3D porous PEEK HAFUSE...
Curiteva has received the 510(k) clearance from the US Food and Drug Administration (FDA) for its 3D printed PEEK implant, the Inspire porous PEEK...
Ulrich medical USA announces first percutaneous spine case for Momentum minimally...
Ulrich medical USA has announced the successful completion of the first case for the Momentum minimally invasive surgery (MIS) system which, according to the...
NuVasive and Globus Medical announce merger
NuVasive and Globus Medical have revealed that they have entered into a definitive agreement to combine in an all-stock transaction. Under the terms of...
Spinal Elements appoints Ron Lloyd as president and chief executive officer
Spinal Elements has announced the appointment of Ronald (Ron) Lloyd as new president and chief executive officer. He succeeds co-founder and former president and...
New research highlights risk factors of medical malpractice litigation due to...
Prompt and accurate diagnosis, co-ordination of care, timely referral for surgical intervention, and understanding of the indications versus limitations of conservative therapy may help...
Vertebral Bone Quality Score a strong predictor of pedicle screw loosening...
The vertebral bone quality (VBQ) score is an influential factor associated with lumbar pedicle screw loosening, and a higher VBQ score is significantly correlated...
High preoperative expectations of decompression plus fusion for lumbar degenerative spondylolisthesis
Patients have a higher preoperative expectation for decompression and fusion compared to decompression alone for the treatment of lumbar degenerative spondylolisthesis (LDS). However, patients...
DiscGenics receives FDA RMAT designation for IDCT for degenerative disc disease
DiscGenics has announced that the US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Injectable Disc Cell Therapy...
Spinal News International’s top 10 most popular stories of January 2023
Our most viewed piece in January was an insightful video interview—conducted at DWG Kongress—with Michael Fehlings (Toronto, Canada) on the management of patients with...
Augmedics reveals 3,000 patient milestone for xvision spine system
Augmedics has announced that it has now treated more than 3,000 patients with its augmented reality (AR) xvision spine system. The news comes just...
New CPT code now effective for second level of lumbar total...
Centinel Spine has revealed that, from 1 January 2023, providers are able to utilise a new Current Procedural Terminology (CPT) code when performing two-level lumbar...
icotec receives FDA clearance for its Ø 4.5mm VADER pedicle screws
icotec has been granted US Food and Drug Administration (FDA) 510(k) clearance to market its VADER pedicle system inclusive of Ø 4.5mm pedicle screws and...
FDA approves Abbott’s spinal cord stimulation system for those with painful...
Abbott has announced that the US Food and Drug Administration (FDA) has approved its Proclaim XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral...
Companion Spine acquires Backbone SAS
Companion Spine has announced the acquisition of Backbone SAS, a company based in Bordeaux, France, that designs, develops, manufactures and markets functional motion restoration...
Orthofix announces full commercial launch and first cases of Mariner deformity...
Orthofix Medical has announced the full commercial launch of, and first patient cases involving, the Mariner deformity pedicle screw system. The first product launched since...
Norwegian study shows equivalent clinical outcomes between public and private hospitals...
Despite a shorter duration of surgery and hospital stay in a private setting, the clinical effectiveness of surgery for degenerative cervical radiculopathy performed in...
Lateral single position surgery offers similar outcomes to circumferential anterior-posterior fusion,...
Lateral single position surgery (LSPS) and circumferential fusions have similar outcomes at two-years postoperatively, while reducing perioperative complications, improving perioperative efficiency and safety, a...
Newborn screening for SMA leads to more children being able to...
Newborn screening (NBS) for spinal muscular atrophy (SMA), when combined with early treatment, results in better movement ability in affected children, including the ability...
Astura Medical receives FDA 510(k) clearance for El Capitan X expandable...
Astura Medical has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its El Capitan X expandable...
VySpine receives FDA clearance for LumiVy NanoVy Ti Lumbar IBF system
VySpine has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its LumiVy NanoVy Ti Lumbar IBF system...
Unilateral pedicle screw fixation as effective as bilateral for TLIF, new...
Unilateral pedicle screw fixation (UPSF) is just as effective as bilateral pedicle screw fixation (BPSF) in transforaminal lumbar interbody fusion (TLIF) and may even...
Life Spine announces first surgical cases of ARx spinal fixation system
Life Spine has announced that the first surgical cases utilising its ARx spinal fixation system have been completed.
According to Life Spine, the ARx spinal...
New study highlights outcomes of cervicothoracic junction instrumentation following separation surgery...
Instrumented fusion across the cervicothoracic junction (CTJ) demonstrated an 18.8% rate of postoperative complications and an 11% overall two-year rate of hardware failure in...
NanoHive receives FDA 510(k) clearance for Hive standalone cervical system
NanoHive Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Hive standalone cervical system. The implant system features...
Decompression alone and decompression with fusion offer similar outcomes for patients...
There is high quality evidence showing that there is no difference in terms of functionality after decompression alone compared to decompression with fusion in...
Surglasses receives FDA 510(k) clearance for Caduceus S AR spine navigation...
Surglasses has announced that its Caduceus S augmented reality (AR) spine navigation system has received 510(k) clearance from the US Food and Drug Administration...
SI-Bone announces FDA clearance for expanded rod compatibility with the iFuse...
SI-Bone has announced additional US Food and Drug Administration (FDA) clearance for its iFuse Bedrock Granite, including new indications with a wide variety of...
Time is spine: A paradigm shift in the management of spinal...
Michael Fehlings (Toronto, Canada) talks to Spinal News International at DWG-Kongress (7–9 December 2022; Berlin, Germany) about the “dramatic shift” over the past 25 years in...
Orthofix and SeaSpine complete merger
Orthofix Medical Inc and SeaSpine Holdings Corporation have announced the successful completion of their merger of equals following the approval of their respective shareholders.
According to...
Spinal News International’s top 10 most popular stories of December 2022
Some major regulatory announcements took centre stage in our most read articles of December, with the top story revealing that the Swiss Federal Assembly...
Empirical Spine completes full premarket approval submission to FDA for LimiFlex...
Empirical Spine has revealed that it has recently completed the final step in the US Food and Drug Administration (FDA) submission process for the LimiFlex...
Abbott launches Eterna spinal cord stimulation system for the treatment of...
Abbott has announced US Food and Drug Administration (FDA) approval of its Eterna spinal cord stimulation (SCS) system—which the company describes as the world’s...
CAVUX facet fixation system granted FDA approval for the treatment of...
Providence Medical Technology has announced that the US Food and Drug Administration (FDA) has cleared its CAVUX facet fixation system (FFS) for a new...
Saluda Medical initiates US commercialisation of the Evoke spinal cord stimulation...
Saluda Medical has announced plans for a limited commercial release of its Evoke spinal cord stimulation (SCS) system in the USA, with a full commercial...
TruLift lateral expandable spacer system and lateral plate system granted FDA...
Life Spine has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its TruLift lateral expandable...
Postoperative wound drains not recommended in some patients undergoing posterior spinal...
In patients undergoing primary posterior spinal decompression and fusion up to three levels for degenerative lumbar disorders, the use of postoperative drains is not...
Top US spinal organisations launch new Coalition for Spine Health
The US National Spine Health Foundation (NSHF) has announced the launch of a first of its kind Coalition for Spine Health. The coalition will initially bring...
Non-pharmacological interventions more beneficial for patients with chronic low back pain...
For patients with chronic non-specific low back pain without radiculopathy, non-pharmacological interventions of acupuncture and spinal manipulation provide safer benefits than pharmacological or invasive...
HAPPE Spine announces Andrew Iott as president and CEO
HAPPE Spine has revealed that Andrew Iott, who has more than 20 years of experience in medical device product development and commercialisation, with extensive knowledge of...
VYRSA Technologies announces worldwide launch of VYRSA V1 SI fusion system
VYRSA Technologies has announced US Food and Drug Administration (FDA) clearance of its VYRSA V1 sacroiliac (SI) fusion system.
According to a press release, after...
Spinal News International’s top 10 most popular stories of November 2022
Taking top spot in our most read Top 10 for November was a comment piece by Brian Fiani (New York, USA), who examined the...
Posterior surgery non-inferior to anterior surgery for cervical foraminal radiculopathy patients,...
Posterior cervical foraminotomy is non-inferior to anterior cervical discectomy with fusion for patients with cervical radiculopathy in relation to procedural success rate and reduction...
Type of cervical disc herniation on MRI does not correlate with...
In patients with cervical radiculopathy, the type and extent of disc herniation measured on magnetic resonance imaging (MRI) prior to surgery correlated neither to...
Insurance plan affects access to and timeliness of surgery for patients...
Insurance type has a significant impact on incidence and time-to-occurrence of surgery for patients with cervical degenerative conditions, according to new research—published in the...
Rosies Base signs research agreement with SpineCraft for next-generation spinal implants
Rosies Base, a startup research and development company, has announced a research agreement with SpineCraft, which will allow the companies to investigate the compatibility...
Accelus announces 15,000 FlareHawk implantation milestone
Accelus has has announced that more than 15,000 FlareHawk multiplanar expandable cages have been implanted in more than 11,000 patients in the USA.
Robert Norton, a...
ChoiceSpine announces line extension of their Harrier standalone ALIF system
ChoiceSpine has announced the launch of an additional 20° lordotic offering for their standalone anterior lumbar interbody—Harrier SA. Harrier SA is a 3D-printed standalone...
Implanet partners with Sanyou Medical in China
Implanet has announced the signing of a distribution agreement for its JAZZ range in China as well as a technology partnership with Sanyou Medical.
Ludovic...
Comment: What role does minimally invasive surgery have in treating those...
Brian Fiani, a neurosurgeon at Weill Cornell Medicine/NewYork-Presbyterian Hospital (New York, USA), examines some of the main benefits and also limitations associated with minimally...
Globus Medical partners with NHS to provide hospitals with surgical robotic...
The National Health Service (NHS) and Globus Medical have partnered to provide state-of-the-art robotic navigation technology for spinal surgery to NHS hospitals across the...
Smoking does not significantly increase risk of adverse events within 90...
Tobacco use is not associated with a statistically significant increased risk of adverse events within 90 days in patients undergoing spinal fusion surgery, a new...
Expert consensus lacking on treatment of degenerative spondylolisthesis
There is little consensus on the treatment of degenerative spondylolisthesis (DS) among members of both the Lumbar Spine Research Society and Society of Minimally...
Spinal Stabilization Technologies announces start of LOPAIN2 clinical trial for lumbar...
Spinal Stabilization Technologies has announced the start of the LOPAIN2 clinical trial of its PerQdisc nucleus replacement device in patients with degenerative disc disease...
COMPaSS personalised spine surgery study begins enrolment
Carlsmed has revealed that the first patients have been enrolled in the COMPaSS study, a multicentre post market prospective observational registry which will collect data...
Centinel Spine announces first commercial use of prodisc C SK cervical...
Centinel Spine has announced the first implantation of its prodisc C SK cervical total disc replacement (TDR) product. In July 2022, the company received US...
UC San Diego Health awarded advanced certification in spine surgery
UC San Diego Health (San Diego USA) has earned The Joint Commission’s Gold Seal of Approval for Advanced Certification in Spine Surgery (ACSS) by...
One-year data from TOPS IDE trial show significant improvement in all...
Premia Spine recently announced the publication of one-year outcomes from the TOPS facet replacement system’s clinical trial which found that lumbar facet arthroplasty with...
First patients implanted with Orthofix’s Legacy Demineralised Bone Matrix
Orthofix has announced the full market release and first implants of Legacy Demineralised Bone Matrix (DBM), a putty for filling voids or gaps in...
AR has the potential to improve workflow for minimally invasive transforaminal...
Augmented reality (AR) has the ability to improve the surgical workflow during minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) procedures, new research, published in...
SeaSpine announces full commercial launch of the Mariner MIS Wayfinder system
SeaSpine has announced the full commercial launch of the Mariner MIS Wayfinder system, a novel, one step, k-wireless screw delivery system for pedicle screw fixation.
According...
Life Spine announces first surgical cases of the ProLift micro endoscopic...
Life Spine has revealed the completion of the first surgical cases utilising its ProLift micro endoscopic expandable spacer system.
ProLift micro is a uniquely designed...
NuVasive launches Tube System and Excavation Micro for posterior spine surgery
NuVasive has announced the commercial launch of the NuVasive Tube System (NTS) and Excavation Micro, a new minimally invasive surgery (MIS) system that the...
Accelus announces FDA clearance for Remi robotic navigation system software update
Accelus has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its Remi robotic navigation system software update that...
Centinel Spine announces prodisc C Vivo cervical total disc replacement milestone
Centinel Spine has announced the completion of the 100th procedure in the USA using its prodisc C Vivo cervical total disc replacement (TDR) device.
Kevin Rutz, an...
Spinal cord burst stimulation provides no significant benefit compared with placebo,...
Among patients with chronic radicular pain after lumbar spine surgery, spinal cord burst stimulation, compared with placebo stimulation, results in no significant difference in...
Spinal implant firm raises £10.8 million after successful product release
Axis Spine Technologies has raised a further £10.8 million in funding which the firm says will enable it to expand to new hospitals, broaden its...
EUROSPINE 2022: Short course of physiotherapy increases likelihood of self-perceived improvement...
Whilst primary carer advice on natural history and activity is adequate for those with recent onset painful cervical radiculopathy, attending a short course of...
Spinal News International’s top 10 most popular stories of October 2022
This month’s Spinal News International top 10 was dominated by research presented at the annual SRS and NASS spine meetings. The top three spots...
Ulrich Medical USA receives 510(k) clearance for Flux-C 3D implant
Ulrich medical USA has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Flux-C 3D printed porous titanium cervical interbody...
EUROSPINE 2022: Prior knowledge of preoperative scores impacts postoperative PROMs for...
Degenerative cervical spine patients who are aware of their preoperative scores demonstrate better patient-reported outcome measures (PROMs) than those who do not, new research...
SeaSpine announces full commercial launch of the 7D FLASH navigation system...
SeaSpine has announced the full commercial launch of the 7D FLASH navigation system percutaneous spine module for minimally invasive surgery.
Douglas Orndorff of Spine...
Genesys Spine announces first patients enrolled in the SIros lateral sacroiliac...
Genesys Spine has announced that the first two patients have been enrolled in the prospective SIros lateral sacroiliac (SI) joint fusion study. Tyler Ptacek...
DePuy Synthes receives FDA clearance for TELIGEN system
DePuy Synthes, the orthopaedics company of Johnson & Johnson, has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its TELIGEN...
Graded sensorimotor retraining can help improve pain intensity for chronic low...
Graded sensorimotor retraining significantly improves pain intensity at 18 weeks, compared to a sham procedure and attention control, for those suffering from chronic low...
NASS 2022: Robotic and navigational assistance is cost-effective for minimally-invasive adult...
Although robotic and navigational assistance systems have a significantly higher upfront cost compared to existing techniques, the findings of a new study—presented at the...
NASS 2022: Baseline quantitative MRI can predict probability of deterioration and...
Baseline quantitative magnetic resonance imaging (qMRI) is able to accurately predict the likelihood of deterioration and surgical intervention in degenerative cervical myelopathy (DCM) patients,...
ONWARD reveals positive topline results of LIFT Home study
ONWARD Medical has reported topline results from the LIFT Home study, which reported no serious adverse events and a 97% rate of successful session...
NASS 2022: Erector spinae plane block safe and effective for posterior...
In patients undergoing posterior cervical spine surgery (PCSS), erector spinae plane block (ESPB) is a safe and effective technique with better outcomes than standard...
CTL Amedica gains FDA clearance for MONDRIAN ALIF cage system with...
CTL Amedica has received official 510(k) clearance from the US Food and Drug Administration (FDA) to market its MONDRIAN anterior lumbar interbody fusion (ALIF)...
NASS 2022: Percutaneous transforaminal endoscopic discectomy a more cost-effective treatment than...
Percutaneous transforaminal endoscopic discectomy (PTED) is more cost-effective from a societal perspective at 24 months than microdiscectomy for patients with sciatica. This is according...
Point Robotics’ handheld spine surgery robot granted 510(k) clearance
Point Robotics has received 510(k) clearance from the US Food and Drug Administration (FDA) for its minimally invasive surgical robot, the POINT kinguide robotic-assisted...
Philips expands rollout of its ClarifEye augmented reality surgical navigation solution...
Philips has announced both the expanded rollout of its augmented reality (AR) surgical navigation solution—ClarifEye—to Japan, as well positive results in the first patients...
Stryker launches Monterey AL interbody system
Stryker has announced the launch of the Monterey AL interbody system, a standalone interbody fusion device designed for anterior lumbar interbody fusion (ALIF).
Monterey AL...
ROTAIO cervical disc prosthesis a safe and effective treatment option for...
The ROTAIO cervical disc prosthesis (Signus) is a safe and efficient treatment option for those with symptomatic degenerative disc disease and demonstrates highly significant...
Life Spine announces FDA 510(k) clearance for its GHOST 3D-printed titanium...
Life Spine has received clearance from the US Food and Drug Administration (FDA) to market the GHOST 3D-printed titanium spacer system, which includes new...
New study highlights key factors affecting return to work after surgery...
Return to work (RTW) after surgery for cervical radiculopathy occurs primarily during the first year and the strongest predictor of RTW is fewer sick...
Orthofix and SeaSpine announce merger
Orthofix and SeaSpine have entered into a definitive agreement to combine in an all-stock merger of equals, with the new combined company to be...
Unilateral pedicle screw fixation with TLIF can achieve similar results to...
Transforaminal lumbar interbody fusion (TLIF) is an appropriate procedure for the treatment of lumbar foraminal stenosis (LFS) and, with balanced intervertebral support using a...
HAPPE Spine announces additional patents for hydroxyapatite porous polyetheretherketone devices
HAPPE Spine has announced the addition of two more issued patents in a growing portfolio of next generation orthopaedic and spinal implants enabled by the...
Upadacitinib ‘safe and effective’ for the treatment of active non-radiographic axial...
Upadacitinib (AbbVie), a Janus kinase inhibitor, significantly improves the signs and symptoms of non-radiographic axial spondyloarthritis compared with placebo at 14 weeks, according to...
SpineX demonstrates novel technology to treat children with cerebral palsy
SpineX has announced the publication of the results of its first in human study using its proprietary non-surgical and non-invasive device, SCiP, to treat...
Aurora Spine receives FDA clearance for its SiLO TFX MIS sacroiliac...
Aurora Spine has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its patented minimally invasive SiLO...
Stryker launches Q Guidance System with Spine Guidance Software
Stryker has announced the launch of its Q Guidance System for spine applications. The system combines new optical tracking options provided by a redesigned,...
SpineGuard and Omnia Medical announce strategic alliance for adult spine surgery...
SpineGuard and Omnia Medical, have signed a co-development and exclusive distribution agreement for adult spine surgery in the USA.
According to a press release, the partnership...
Spine BioPharma announces first patient treated in US Phase 3 clinical...
Spine BioPharma recently announced the first patient treated in a Phase 3 clinical study of SB-01. This, according to the company, is the first...
Ventris Medical receives 510(k) clearance for Amplify standalone bone graft putty...
Ventris Medical has announced that the US Food and Drug Administration (FDA) has granted it 510(k) clearance for its synthetic bone graft putty, Amplify.
Amplify...
Long-term curve progression of idiopathic scoliosis: 40-year follow-up
In idiopathic scoliosis (IS) patients, long-term curve progression for curves between 30 and 50° at skeletal maturity is both substantial and comparable to curves...
RevBio receives NIH grant to explore the treatment of VCFs with...
RevBio has been awarded a phase one small business innovation research grant from the National Institute on Aging, part of the National Institutes of...
SRS 2022: Technology can help transform scoliosis patient data extraction from...
Natural language processing (NLP) and computer vision methods have the potential to transform the extraction of scoliosis data elements from text and imaging electronic...
Spinal News International’s top 10 most popular stories of September 2022
Research showing that minimally invasive surgery is a safe and effective option for those with cerebrospinal fluid leaks was our most read story in...
First commercial use of prodisc C Vivo in Western US
Centinel Spine has announced the first implantation of its prodisc C Vivo cervical total disc replacement (TDR) product in the Western US. The procedure was undertaken by...
SRS 2022: Preoperative carbohydrate drink can benefit paediatric spinal fusion patients
The use of a preoperative carbohydrate drink for paediatric spinal fusion patients is not only safe, but significantly improves time to return of bowel...
CTL Amedica bags Taiwanese regulatory approval for MATISSE ACIF cage system
The Taiwan Food and Drug Administration (TFDA) has granted CTL Amedica a license for its MATISSE anterior cervical interbody fusion (ACIF) cage system, allowing...
NuVasive launches Reline Cervical for posterior cervical fusion
NuVasive has announced the expansion of its C360 portfolio following the commercial launch of Reline Cervical, a new fixation system for posterior cervical fusion (PCF),...
Synergy Spine Solutions and Ortho Consulting Group extend strategic partnership to...
Synergy Spine Solutions has extended its strategic partnership with Ortho Consulting Group (OCG) as the company looks to continue its expansion across the EMEA region.
OCG...
SRS 2022: Use of high-dose tranexamic acid not associated with higher...
There is strong evidence that the use of high-dose tranexamic acid (TXA) is not associated with an increased risk of medical complications, compared to...
Stryker receives FDA clearance for OptaBlate bone tumour ablation system
Stryker has announced that its first interventional oncology technology, the OptaBlate bone tumour ablation system, has received 510(k) clearance from the US Food and...
Scoliosis Research Society unveils its first female president
The Scoliosis Research Society (SRS), which was founded in 1966, has appointed its first ever female president.
Serena Hu, professor of orthopaedic surgery at Stanford...
Surgalign expands Fortilink product line
Surgalign has announced the expansion of its Fortilink product portfolio with the introduction and commercial launch of a new family of interbody fusion devices...
Spinopelvic alignment should influence treatment option of grade I degenerative spondylolisthesis...
Lumbar laminectomy with fusion is superior to laminectomy alone in terms of health-related quality of life and reoperation rate at two years postoperatively for...
Reducing intraoperative cone beam CT radiation dose does not increase risk...
Reducing the radiation dose of intraoperative cone beam computed tomography (CBCT) during posterior spinal fusion (PSF) for paediatric scoliosis does not lead to an...
Timing of tether breakage influences clinical results after VBT
Tether breakage after vertebral body tethering (VBT) leads to a consistent loss of correction when it occurs within the first 12 months. However, it...
Elevation Spine closes US$11 million Series B financing round
Elevation Spine has announced the completion of its Series B preferred stock financing, with the US$11 million raised going towards boosting the commercial production...
New spine company focused on ambulatory surgery centres formed
Healthcare investment firm KICVentures Group, led by orthopaedic spine surgeon Kingsley Chin (Fort Lauderdale, USA), has announced the formation of a new company, NANISX,...
Altus Spine receives patent allowance of Pars Repair Device to treat...
Altus Spine has received Notice of Allowance from the United States Patent and Trademark Office on its Pars Repair Device—a new device which the...
Minimally invasive surgery for spinal cerebrospinal fluid leaks “safe and effective”...
Minimally invasive surgery with tubular retractors and a tailored interlaminar fenestration and, if needed, a transdural approach, is safe and effective for the treatment...
Lumbar Synovial Cyst Score a “quick and accurate” tool for predicting...
The Lumbar Synovial Cyst Score model is a quick and accurate tool that can assist in the clinical decision-making process when treating those with...
Augmedics celebrates completion of 2,000th xvision case
Augmedics has announced the milestone achievement of 2,000 commercial cases completed utilising its xvision spine system.
The US Food and Drug Administration (FDA)-cleared xvision system...
SeaSpine announces full commercial launch of the WaveForm TA interbody system
SeaSpine has announced the full commercial launch of the WaveForm TA (transforaminal lumbar interbody fusion articulating) interbody system.
The WaveForm TA Interbody isystem is...
Measures needed to combat growing incidence and burden of spinal cord...
The incidence and burden of spinal cord injury (SCI) has increased during the past 30 years and effective measures are needed to face the...
RIWOspine launches new product line
RIWOspine is expanding its product portfolio to include an innovative segment in the field of minimally invasive spinal surgery. The new evospine product range...
AI can help determine surgical candidacy of LSS patients to comparable...
Artificial intelligence (AI) can be used to bring efficiency and automation to the decision-making process for determining surgical candidacy for those with lumbar spinal...
ACDF offers benefits over PCLF for cervical spondylotic myelopathy but postoperative...
Anterior cervical discectomy and fusion (ACDF) and posterior cervical laminectomy and fusion (PCLF) provide comparable postoperative neck pain improvement at three, 12, and 24...
eCential Robotics receives FDA clearance for its surgical robotic platform for...
eCential Robotics has announced US Food and Drug Administration (FDA) 510(k) clearance of its 3D imaging, navigation and robotics guidance system.
Created in 2009 by...
NeuraMedica receives FDA 510(k) clearance for DuraFuse dural clips
NeuraMedica has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its DuraFuse dural clips which, according to...
Spinal News International’s top 10 most popular stories of August 2022
Six-month data comparing the Nexxt Matrixx 3D-printed titanium interbody family to PEEK devices was our top story in August. The news that Sheeraz Qureshi...
Wenzel Spine launches S-LIF procedure for standalone lumbar interbody fusion
Wenzel Spine has announced the launch of the S-LIF procedure for standalone lumbar interbody fusion using the VariLift-LX device, which the company says is...
Indirect decompression does not provide superior long-term benefits to direct decompression...
Indirect decompression (ID) for the treatment of lumbar spondylolisthesis does not provide superior long-term clinical outcomes compared to direct decompression (DD), new research has...
SeaSpine announces full commercial launch of Meridian anterior lumbar interbody system
SeaSpine has announced the full commercial launch of its Meridian anterior lumbar interbody fusion (ALIF) system featuring the Reef A interbody.
The Meridian anterior lumbar...
Orthofix and CGBio announce strategic partnership agreement for bone graft solutions
Orthofix has signed a strategic partnership agreement with CGBio, a developer of synthetic bone grafts currently used clinically in Asia for spine, orthopaedic, trauma...
United Spinal Association announces new appointments to its board of directors
United Spinal Association has appointed five new members to its board of directors for the new fiscal year: Attorney Felecia Woolens, SUNY Stony Brook...
Nexus Spine announces full commercial launch of PressON posterior lumbar fixation...
Nexus Spine has announced the full commercial launch of its PressON posterior lumbar fixation system which features rods that press onto pedicle screws rather than...
Spineology launches fully endoscopic, single-tubular retractor fusion system
Spineology has announced the limited launch of OptiLIF Endo—an ultra-minimally invasive system that requires just one tubular retractor to integrate endoscopes and endoscopic equipment into...
AxioMed submits final Module III to the FDA for lumbar viscoelastic...
AxioMed has announced that it has submitted to the US Food and Drug Administration (FDA) all the required documents for PMA Module III, as...
Surgalign announces FDA 510(k) clearance of the Cortera spinal fixation system
Surgalign has received US Food and Drug Administration (FDA) 510(k) clearance of its Cortera spinal fixation system— a 5.5/6mm rod pedicle screw system, that has...
Spatial distribution of fat infiltration within the paraspinal muscles a potentially...
Spatial distribution patterns of fat infiltration (FI) in the paraspinal muscles (PSMs) is a potential diagnostic biomarker that may also provide granular mechanistic insights...
Operative treatment for adult cervical deformity offers significant improvements at three-year...
Operative treatment for adult cervical deformity (ACD) provides significant improvements in health-related quality of life at a mean 3.4-year follow-up, despite high complication rates...
No association between operation type and incidence of revision surgery for...
There is no significant association between the type of index operation—decompression alone or decompression with fusion—and incidence of revision surgery or the outcomes of...
NuVasive announces departure of chief commercial officer
NuVasive recently announced the resignation of its executive vice president and chief commercial officer, Massimo Calafiore. Calafiore will be leave NuVasive on August 31 to...
Zavation Medical Products receives FDA 510(k) clearance for Varisync anterior cervical...
Zavation Medical Products has received US Food and Drug Administration (FDA) 510(k) clearance of Varisync, a cervical intervertebral body fusion device.
The most recent addition to the...
Theragen receives patent for spine fusion bone growth stimulator with digital...
Theragen has announced that it has been granted a US patent for the development of its ActaStim-S spine fusion bone growth stimulator system.
ActaStim-S blends...
Spinal News International’s top 10 most popular stories of July 2022
A debate on the use of robotics in spine surgery was the most popular piece on Spinal News International in July, closely followed by...
Hospital for Special Surgery appoints Sheeraz Qureshi as co-chief of spine...
Hospital for Special Surgery (HSS; New York, USA) has announced the appointment of Sheeraz Qureshi, as co-chief of HSS Spine, effective 1 October 2022.
Qureshi will succeed Harvinder Sandhu,...
Kleiner Device Labs completes first surgery with KG2 Surge flow-thru interbody...
Kleiner Device Labs has announced that its new KG2 Surge flow-thru interbody system was used in its first surgical procedure. Anders Cohen performed a...
VyPlate anterior cervical plate system granted FDA clearance
VySpine has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its VyPlate anterior cervical plate (ACP) system....
Promising results associated with sacroiliac joint fusion for patients with lower...
Sacroiliac joint fusion (SIJF) shows potential as a surgical treatment option for those with lower back pain as a result of sacroiliac joint (SIJ)...
joimax expands distribution in China
German-based joimax has announced an exclusive partnership with Andeller (Nanjing) Healthcare and Technology Co for distribution in China.
Under the new strategic partnership, which is...
Orthofix announces first clinical use of Virtuos lyograft autograft substitute
Orthofix has announced the limited market release and first patient implant of the Virtuos lyograft, which the company describes as a first-of-its-kind, shelf-stable and complete...
Duration of preoperative pain linked to chronic opioid use after adult...
For patients who underwent adult spinal deformity (ASD) surgery, preoperative opioid use and pain duration of four or more years were independently associated with...
Researchers discover neural plastic changes that improve functional recovery after cervical...
Spinal cord and brain injury researchers at Indiana University School of Medicine (Indianapolis, USA), are studying new alternatives to promote functional recovery after a...
Wenzel Spine announces first awake spinal fusion using VariLift-LX
Wenzel Spine has announced that the first awake spinal fusion procedure using its VariLift-LX interbody implant has been performed.
The less invasive spine surgery (LISS) was performed...
Nexus Spine announces beta launch of Stable-C cervical interbody system with...
Nexus Spine has announced the beta launch of its Stable-C cervical interbody fusion implants featuring integrated anchoring blades.
The limited release adds to the company’s growing...
SATURN study highlights favourable outcomes for NeuorAiD in spinal cord injury...
NeuroAiD (MLC601/MLC901; Moleac) has a favourable safety profile and promising benefits as an add-on therapy to patients suffering from severe spinal cord injuries (SCIs)...
First commercial cases using the Karma MIS system performed
Spinal Elements has revealed that orthopaedic surgeon Pierce Nunley (Specialists Hospital Shreveport, Shreveport, USA), completed the first two commercial cases with its Karma minimally...
Nexxt Spine reveals early clinical evidence and completes enrolment for Nexxt...
Nexxt Spine has announced the completion of enrolment and six-month clinical data collection comparing the Nexxt Matrixx 3D-printed titanium interbody family to polyetheretherketone (PEEK)...
Spiderwort secures US$13.2 million in Series A financing
Spiderwort has announced the successful completion of its US$13.2 million Series A financing round, the money of which will be used to further develop its...
Systemic problems rather than patient-physician relationship most likely reason for racial...
The disparities in chronic low back pain experienced by Black patients compared to White patients are not linked to the patient-physician relationship but are...
NuVasive porous titanium interbody implant and synthetic bone graft substitute a...
The use of entirely synthetic solutions featuring porous titanium interbody implants and a bone graft substitute have clinical and economic advantages compared with traditional, non-porous...
VisAR augmented reality guidance system achieves promising results in spine surgery...
The VisAR augmented reality surgical guidance system (Novarad) is a highly accurate, emerging technology for navigating both open and minimally invasive spine surgery (MISS)...
Routine use of antibiotics after spine surgery may not be warranted
Routine use of postoperative antibiotics in spine surgery may not be effective in preventing surgical site infections (SSIs), according to a recent systematic review...
Comment: Endoscopic techniques “the next logical step” for the decompression of...
Daniel Sauer and Christoph Siepe of the Schön Klinik München Harlaching (Munich, Germany) discuss some of the benefits of endoscopic surgery compared with microsurgery...
Centinel Spine announces full commercial launch of FORTOS-C anterior cervical plating...
Centinel Spine has expanded its cervical solutions portfolio following the full commercial launch of its FORTOS-C anterior cervical plating system.
The FORTOS-C plate is a titanium anterior...
Staged surgery and simultaneous surgery associated with similar outcomes for patients...
For the treatment of tandem spinal stenosis (TSS), staged and simultaneous surgery have comparable perioperative, functional and neurologic outcomes, as well as complication rates....
Altus Spine agrees private label partnership with Nanovis Spine
Altus Spine has announced a private label partnership with Nanovis Spine to further strengthen and expand their bioceramic nanotube surface technologies throughout their portfolio.
A...
RECODE-DCM: Global consensus reached on degenerative cervical myelopathy as single unifying...
A global, multi-stakeholder consensus process involving those with lived experience has selected degenerative cervical myelopathy (DCM) as the single unifying term for a progressive...
Aurora Spine bags FDA lumbar spinal stenosis indication clearance for ZIP...
Aurora Spine has announced US Food and Drug FDA clearance of a new lumbar spinal stenosis indication for use for its ZIP family of...
Oligodendrocyte progenitor cells can be safely administered to patients in the...
Oligodendrocyte progenitor cells (LCTOPC1; Lineage Cell Therapeutics) can be safely administered to participants in the subacute period after cervical spinal cord injury (SCI), according...
Waypoint Orthopedics submits FDA 510(k) application for Waypoint GPS system
Waypoint Orthopedics recently announced the submission of a US Food and Drug Administration (FDA) 510(k) application for its Waypoint GPS—a bone awl for use...
No real benefit for rigid thoracolumbar orthosis over elastic lumbar support...
Rigid thoracolumbar orthosis devices do not provide any benefits over an elastic lumbar support in terms of bony union or health-related quality of life...
LimiFlex Dynamic Sagittal Tether moves one step closer to commercial launch
Empirical Spine recently had its pre-market approval (PMA) Module II accepted and closed by the US Food and Drug Administration (FDA), an important milestone in...
Further three prodisc cervical total disc replacement devices granted FDA approval
Centinel Spine has announced US Food and Drug Administration (FDA) pre-market application (PMA) approval for one-level indications for three additional cervical total disc replacement...
Tritanium posterior lumbar cage an ‘effective alternative’ to PEEK cages for...
For the treatment of degenerative disc disease (DDD), the Tritanium posterior lumbar cage (Stryker) is an effective alternative to polyetheretherketone (PEEK) cages, with higher...
IDE study data demonstrate significant benefits of M6-C artificial cervical disc...
Patients who received the M6-C artificial cervical disc (Orthofix) continue to show statistically significant benefits compared to those who underwent anterior cervical discectomy and...
Medtronic receives FDA clearance for next-generation UNiD Spine Analyzer
Medtronic has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its UNiD Spine Analyzer v4.0 planning platform, which...
Racial and socioeconomic disparities affect postoperative outcomes for spine surgery patients
Racial and socioeconomic disparities in patients’ preoperative physical and mental health at presentation for spine surgery are associated adversely with postoperative outcomes, new research...
Cutting Edge Spine announces received FDA 510(k) clearance of T-FIX 3DSI...
Cutting Edge Spine has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance of its T-FIX 3DSI joint fusion system....
First US surgeries performed in BalancedBack total joint replacement IDE trial
3Spine has announced completion of the first series of US surgeries in the BalancedBack total joint replacement investigational device exemption (IDE) pivotal clinical trial.
All...
BioRestorative Therapies enrols first patient in chronic lumbar disc disease trial
BioRestorative Therapies has announced that the first patient has been enrolled in the its phase 2 clinical trial evaluating the safety and preliminary efficacy...
AlloSource launches new micro fibres demineralised bone allograft for spine procedures
AlloSource has announced the addition of AlloFuse micro fibres demineralised bone allograft for use in spinal, foot and ankle or other orthopaedic procedures.
The micro...
Meta-analysis highlights benefits of spinal manipulative therapy for older adults with...
Spinal manipulative therapy (SMT) is equally as effective as recommended interventions for reducing pain and increasing functional status in older adults who suffer chronic...
Novel supine correction index helps predict brace outcomes in adolescent idiopathic...
Curve progression with brace treatment in patients with adolescent idiopathic scoliosis (AIS) can be predicted by their curve flexibility and in-brace correction rate, new...
Oxford Performance Materials and Fuse Medical join forces to develop new...
Oxford Performance Materials (OPM) has announced an agreement with Fuse Medical to develop new, spinal, extremity and sports medicine implant product lines utilising the former’s...
Cannabis use associated with increased use of prescription opioids following posterior...
Cannabis usage is associated with increased usage of opioids postoperatively, both while in-patient and post-discharge, following posterior lumbar spinal fusion surgery. This is the...
First surgeries using SureMAX-SA standalone cervical spacer conducted
Additive Implants has announced the first implantations of the SureMAX-SA cervical standalone spacer—a 3D-printed titanium device which the company claims offer unmatched options in...
Insurance type associated with differing patient-reported outcomes in those with lumbar...
Patients with lumbar spinal stenosis (LSS) who are insured in the USA through Medicaid have systematically worse baseline patient-reported outcome measures (PROMs) across almost...
SpineX announces first patient enrolment in SCONE clinical trial
SpineX has revealed that the first patient has been enrolled in a pivotal trial which will evaluate the safety and effectiveness of the company’s...
Study suggests hereditary link for adolescent spinal deformity
There is a considerable increased risk for adolescent spinal deformity (ASD) among those whose parents have suffered spinal deformities, according to a new national...
Enrolment completed in ONWARD’s LIFT Home study
ONWARD Medical has announced that it has completed enrolment in the LIFT Home study, which is designed to evaluate the safety and performance of...
Spinal News International’s top 10 most popular stories of June 2022
Our top story in June came from a modified Delphi study presented at the Global Spine Congress 2022 (1–4 June; Las Vegas, USA) which...
Xenco Medical launches Multilevel CerviKit
Xenco Medical has expanded its ambulatory surgery centre (ASC) surgical device portfolio through US Food and Drug Administration (FDA) clearance and launch of its...
Early study suggests novel, injectable gel may greatly reduce chronic low...
An experimental formulation of a hydrogel, injected into spinal discs, proved safe and effective in substantially relieving chronic low back pain caused by degenerative...
SeaSpine announces full commercial launch of WaveForm C 3D-printed interbody system
SeaSpine has announced the full commercial launch of the WaveForm C interbody system—the company’s first cervical 3D-printed interbody device.
The WaveForm C interbody system has...
Debate: Should robotics technology be more widely adopted in spine surgery?
The use of robotics in the field of spine surgery is a much discussed and controversial topic, with numerous physicians arguing both for and...
Theradaptive secures breakthrough device designation for spinal fusion implant
Theradaptive has announced that the US Food and Drug Administration (FDA) has granted breakthrough medical device designation for the use of its OsteoAdapt SP...
SI-Bone receives FDA 510(k) clearance for iFuse Bedrock Granite
SI-Bone has announced that it has received US Food and Drug Administration (FDA) 510(k) premarket clearance for its iFuse Bedrock Granite implant system (Granite)—which...
SMAIO receives FDA 510(k) clearance for K-rod range
SMAIO has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its patient-specific K-rod union rods which, combined with...
Surgical decompression provides significant improvement to patients with cervical spondylotic myelopathy...
Patients with cervical spondylotic myelopathy experience maximal improvement in their quality of life, neck disability, myelopathy score, and overall health out to three months...
3D augmented reality surgical navigation system achieves FDA approval for precision...
VisAR, an augmented reality surgical navigation system from healthcare technology company Novarad, has received US Food and Drug Administration (FDA) 510(k) approval for precision...
Revision discectomy associated with higher rates of subsequent lumbar fusion than...
Revision discectomy is associated with higher rates of subsequent lumbar fusion (SLF) and faster time to SLF that primary discectomy at eight-year follow-up. This...
NGMedical launches ART spinal fixation system
NGMedical recently announced the launch of its new ART fixation system in Europe. It has been designed with the aim of providing surgeons with...
Roger Härtl named AANS Humanitarian of the Year
Roger Härtl, co-director of Och Spine at NewYork-Presbyterian and director of Weill Cornell Medicine’s Center for Comprehensive Spine Care (New York, USA), was recently...
Inspired Spine hits 1,500 oblique lateral lumbar interbody fusion procedure milestone
Inspired Spine has announced that it has reached the milestone of completing 1,500 oblique lateral lumbar interbody fusion (OLLIF) procedures.
According to a company press...
eCential Robotics and ChoiceSpine announce long-term partnership to enhance robotic spine...
eCential Robotics and ChoiceSpine recently announced a long-term partnership to offer a common optimised solution which they say combines navigation, robotics, and implant systems...
3Spine granted investigational device exemption approval
3Spine has announced US Food and Drug Administration (FDA) investigational device exemption (IDE) approval for a US pivotal clinical trial for their MOTUS spinal...
Nexxt Spine receives United States patent award
Nexxt Spine has received a United States patent award for their rTLIF Rotatable Interbody design, which aims to improve implant positioning and aid insertion...
Altus Spine announces FDA clearance of Sochi OCT system
Altus Spine has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance of its Sochi OCT system—which is comprised of...
SeaSpine announces full commercial launch of the WaveForm TO 3D-printed interbody...
SeaSpine has announced the full commercial launch of its 3D-printed WaveForm TO (transforaminal lumbar interbody fusion oblique) interbody system which has been designed...
Zavation bags FDA 510(k) clearance for eZspand Lateral cage
Zavation Medical Products has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance of its expandable lumbar interbody fusion cage, eZspand Lateral.
According...
GSC 2022: Heavier patients at greater risk of infection after spinal...
Heavier patients frequently receive an inadequate weight-based dose of preoperative cefazolin and as such have an increased risk of infection following spinal fusion surgery....
GSC 2022: Stereotactic body radiotherapy associated with better local control and...
The risk of local failure is three and a half times greater after conventional external beam radiotherapy (cEBRT) when compared to stereotactic body radiotherapy...
SMAIO receives FDA 510(k) clearance for its Balance Analyzer 3D surgery...
SMAIO has received US Food and Drug Administration (FDA) 510(k) clearance for its Balance Analyzer 3D surgery planning software.
Balance Analyzer 3D is spinal realignment planning software...
GSC 2022: Expert consensus reached on clinical application of lateral lumbar...
A modified Delphi method has been used to ascertain expert consensus from the Chinese Study Group for Lateral Lumbar Spine Surgery in an effort...
First surgeries using Excelsius3D performed
Globus Medical has announced the first surgeries performed using its intraoperative three-in-one imaging platform, Excelsius3D.
Paul McAfee and Mesfin Lemma at MedStar Union Memorial Hospital...
InVivo Therapeutics announces full enrolment for INSPIRE 2.0 acute spinal cord...
InVivo Therapeutics has completed enrolment in the INSPIRE 2.0 study for patients with acute spinal cord injury. The 20-patient study is a randomised, controlled...
Aurora Spine receives FDA 510(k) clearance for its DEXA SOLO-L ALIF...
Aurora Spine has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its 3D-printed DEXA SOLO-L anterior lumbar interbody...
Camber Spine’s SPIRA-P and SPIRA-T devices enter full national launch mode
Camber Spine has announced that it is entering into the next phase of the complete national launch of its SPIRA-P posterior lumbar spacer and has recently commercialised its SPIRA-T...
Viseon hits 1,000 case milestone with MaxView imaging platform
Viseon has announced that it recently achieved the milestone of 1,000 minimally invasive spine surgery cases in the USA utilising its MaxView intraoperative realtime...
3Spine appoints Pierce Nunley to medical advisory board
3Spine has announced the appointment of Pierce Nunley, director of the Spine Institute of Louisiana (Shreveport, USA), to its medical advisory board.
The appointment was...
Altus Spine announces FDA clearance of Monaco HA pedicle screw system
Altus Spine has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance of its Monaco HA pedicle screw system.
The Monaco...
Stryker receives FDA clearance for Q Guidance System
Stryker has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its Q Guidance System, which—when used with the...
Spinal News International’s top 10 most popular stories of May 2022
A meta-analysis on cervical artificial disc replacement versus ACDF for those with single-level cervical spondylotic myelopathy was our most read story on Spinal News...
Is awake spine surgery a wave of the future?
Two experts outline their views on whether or not awake spine surgery will gain significant traction over the coming years.
Awake spine surgery IS...
Accelus receives US FDA 510(k) clearance for its Toro-L interbody fusion...
Accelus has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Toro Lateral (Toro-L) interbody fusion system—a biplanar expandable lateral...
High curve magnitude and limited flexibility the main risk factors for...
High curve magnitude and limited flexibility are major risk factors for early tether breakage following vertebral body tethering (VBT), new research has shown. The...
SeaSpine announces full commercial launch of Explorer TO expandable interbody system
SeaSpine has announced the full commercial launch of its Explorer TO (TLIF Oblique) expandable interbody system.
The system provides a posterior interbody solution that offers two...
Yoga a promising treatment option for those with neuropathic pain due...
Stretch and strength-based yoga exercise exercises could be a promising treatment option for patients with neuropathic pain due to lumbar disc herniation (LDH), according...
CTL Amedica granted FDA 510(k) approval for Navigation Instrument System
CTL Amedica has received official 510(k) clearance from the US Food and Drug Administration (FDA) to market its Navigation Instrument System. The system features...
Telemedicine has a future in spine surgery but further evidence needed...
Telemedicine is here to stay in spine surgery due to evidence of high patient satisfaction and significant cost savings but questions remain over whether...
Biogennix’s DirectCell advanced bone grafting system used in 500th case
Biogennix has announced that its DirectCell advanced bone grafting system has now been used in more than 500 cases.
The DirectCell system includes a bone graft product with...
Myelopathy.org launches new website to better support those with degenerative cervical...
Myelopathy.org, which was founded in 2017 as a collaborative information and support initiative for those affected by degenerative cervical myelopathy (DCM), has announced the...
Carlsmed raises US$30M in Series B funding
Carlsmed recently announced that it has closed an oversubscribed US$30M Series B funding round, which will be used to ramp up commercialisation of aprevo,...
Machine learning can help predict early-onset adjacent segment degeneration following ACDF
Machine learning (ML) can help in the discovery of early-onset adjacent segment degeneration (EO-ASD) as well as predict its development following anterior cervical discectomy...
Nanox receives FDA 510(k) clearance for its AI HealthOST device
Nanox has announced that its deep-learning medical imaging analytics subsidiary, Nanox.AI, recently received US Food and Drug Administration (FDA) 510(k) clearance for its HealthOST...
Cervical artificial disc replacement associated with better functional outcomes than ACDF...
Cervical artificial disc replacement (c-ADR) provides better functional outcomes than anterior cervical discectomy and fusion (ACDF) in patients with single-level cervical spondylotic myelopathy (CSM),...
ONWARD announces first-in-human use of its ARC implantable neurostimulator for spinal...
ONWARD Medical has announced the first patient enrolment in the HemON study and first-in-human use of the company’s ARC implantable pulse generator (IPG), which is...
CTL Amedica awarded US patent for KLIMT cage design
CTL Amedica has been granted an official patent by the United States Patent and Trademark Office for its KLIMT expandable lumbar interbody fusion cage...
Spinal Simplicity launches Minuteman G5 implant
Spinal Simplicity has announced the launch of its Minuteman G5 implant—a minimally invasive, interspinous-interlaminar fusion device intended for the fixation and stabilisation of the thoracic,...
Operative treatment for ASD associated with significant long-term health-related quality of...
Operative treatment for adult spinal deformity (ASD) provides significant improvement in health-related quality of life at minimum three-year follow-up (mean 4.1 years), suggesting that...
Accelus launches TiHawk7 expandable interbody cage to support endoscopic and MIS...
Accelus has announced both the launch and first procedures performed utilising its TiHawk7 expandable interbody cage—the latest addition to its FlareHawk interbody fusion system portfolio...
ReVivo Medical announces first ever in-human use of its cervical fusion...
ReVivo Medical has announced that Darryl DiRisio (Albany, USA) has successfully completed the first two surgical procedures using the company’s new design of anterior...
Wenzel Spine announces new leadership
Wenzel Spine has announced that its board of directors has appointed Warren Neely as chairman of the board and William (Bill) Wilson as president...
Pre-transfusion testing only necessary for select degenerative cervical spine surgery patients
Pre-transfusion testing for all patients undergoing degenerative cervical spine surgery is unnecessary and only patients with preoperative haemoglobin (Hgb) lower than 12 gr/dl would...
US National Spine Health Foundation celebrates 50-member medical and scientific board...
To celebrate its 20th anniversary, the US National Spine Health Foundation (NSHF) has announced the 50 top spine experts who comprise its medical and...
First successful surgical procedure performed using HOLO Portal surgical guidance system
Surgalign has announced that its HOLO Portal surgical guidance system has officially entered clinical use, with the first procedure performed at Indiana Spine Hospital...
OrthoSon completes £8.9m Series A financing to help develop low back...
OrthoSon has announced the completion of a £8.9m Series A financing round to help prepare its proprietary back pain treatment for Phase I trials...
Cartilage endplate composition has a significant impact on disc degeneration
Poor cartilage endplate (CEP) composition plays a significant role in disc degeneration severity and can affect disc health both with and without deficits in...
ChoiceSpine launches Harrier standalone anterior lumbar interbody fusion system
ChoiceSpine has announced the full market release of its next-generation Harrier standalone anterior lumbar interbody fusion (ALIF) system.
Harrier SA is a 3D-printed standalone screw-based...
One in five older adults regret undergoing corrective surgery for adult...
One-in-five older adults regret their decision to undergo corrective surgery for adult spinal deformity (ASD), new research—published in the journal Spine by Owoicho Adogwa...
Camber Spine patents its Variant Retractor device
Camber Spine has announced that it has received a notice of allowance from the United States Patent and Trademark Office (USPTO) for its Variant...
Data show superiority of Simplify cervical disc compared to ACDF for...
Results from a two-level multicentre US Food and Drug Administration (FDA) investigational device exemption (IDE) study have shown superior outcomes with the Simplify cervical...
Spinal News International’s top 10 most popular stories of April 2022
Our most popular article in April was a debate between two experts in the field—Paul Houle (Hyannis, USA) and Jeremy Steinberger (New York, USA)—on...
Empirical Spine submits PMA Module II for LimiFlex Dynamic Sagittal Tether
Empirical Spine recently submitted premarket approval (PMA) Module II in the US Food and Drug Administration (FDA) approval process for its LimiFlex Dynamic Sagittal...
IMAST 2022: Vitamin D deficiency may play a role in the...
Dietary vitamin D supplementation can potentially offer a benefit to those with adolescent idiopathic scoliosis (AIS), according to new research which found that a...
IMAST 2022: Use of low radius of curvature implants increases the...
In patients with early onset scoliosis (EOS), implants with a lower radius of curvature (ROC) are associated with an increased risk of clinically significant...
IMAST 2022: Instrumented posterolateral fusion associated with similar patient outcomes but...
Although there was no difference in patient reported outcomes (PROs) between those who underwent surgery for decompression with instrumented posterolateral fusion (IPLF) and those...
Spine Innovations marks 20,000 ESP spinal disc implant milestone
Spine Innovations has announced that more than 20,000 of its ESP spinal disc replacements have now been successfully implanted in patients around the world....
IMAST 2022: New research highlights high failure rates of anterior VBT...
Anterior vertebral body tethering (VBT) for Lenke 1/2 curves with lumbar C modifier is associated with significantly higher failure rates if both curves are...
TheraCell acquired by Isto Biologics
Isto Biologics has acquired TheraCell as is looks to increase its focus on offering solutions for surgical and clinical care procedures within spine, orthopaedics,...
SpineGuard obtains FDA clearance for commercial release of its Threaded PediGuard...
SpineGuard has received 510(k) clearance by the US Food and Drug Administration for the commercial release in the USA of its Threaded PediGuard device...
restor3d raises US$23 million to expand 3D-printed surgical solutions
Medical device company restor3d has raised US$23 million as it looks to expand delivery of its 3D-printed personalised surgical solutions across multiple musculoskeletal specialties....
Astura Medical bags FDA 510(k) clearance for El Capitan Oblique ALIF...
Astura Medical has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its El Capitan Oblique anterior...
SpinaFX Medical appoints Kieran Murphy as chief medical officer
Minimally invasive image-guided therapy startup, SpinaFX Medical, has announced the appointment of Kieran Murphy (University Health Network , Toronto, Canada) as chief medical officer...
BASS 2022: Vertebral augmentation can significantly shorten length of hospital stay...
Hospitalised patients with vertebral fragility fractures (VFF) represent a significant number, cost and use of bed days in England, however those who had early...
BASS 2022: Non-fusion anterior scoliosis correction in skeletally mature children a...
Non-fusion anterior scoliosis correction (NFASC) as an alternative to fusion to stabilise progressive idiopathic scoliosis in skeletally mature children with double sided curve is...
BASS 2022: Early mobilisation after incidental dural tear significantly lowers risk...
Although early mobilisation after repaired incidental dural tears has similar major complication and reoperation rates compared to later mobilisation, it does, however, significantly decrease...
COVID, robotics and treating the frail among the key themes at...
David Cumming, the current president of the British Association of Spine Surgeons (BASS), speaks to Spinal News International about some of the main messages...
Spine BioPharma completes US$13m Series B financing round
Spine BioPharma, a biopharmaceutical company that aims to develop non-opiate, non-surgical therapies for the treatment of pain and disability from chronic low back pain...
Spinal News International’s top 10 most popular stories of March 2022
Positive interim data that highlighted the safety and efficacy of DiscGenics’ cell therapy for degenerative disc disease was the most-read story on Spinal News...
HAPPE Spine announces new additions to board of directors
HAPPE Spine has announced two new additions to its board of directors following a US$3.35 million Series A financing round, the funds of which will be...
Debate: Will endoscopic surgery become the standard of care for spinal...
Two experts from the field of spine surgery, Paul Houle (Hyannis, USA) and Jeremy Steinberger (New York, USA), go head-to-head on the controversial topic...
Neuroplast enrols first patient in Phase II clinical trial of Neuro-Cells...
Neuroplast has enrolled its first patient in a Phase II clinical trial to evaluate efficacy of its transformative Neuro-Cells treatment that aims to prevent further...
Augmedics adds former DePuy Synthes president to board of directors
Augmented reality (AR) surgical navigation firm, Augmedics, recently announced the appointment of Nadav Tomer as an independent director to the company’s board of directors.
Tomer...
Routine use of screening MRI and pre-emptive treatment “not warranted” to...
The routine use of screening magnetic resonance imaging (MRI) and pre-emptive treatment to prevent clinical spinal cord compression (cSCC) is not warranted in patients...
Biocomposites signs agreement with Zimmer Biomet to distribute new genex bone...
Biocomposites has entered into a multi-year agreement with Zimmer Biomet to exclusively distribute its genex bone graft substitute with its new mixing system and...
Saluda Medical raises US$125m to boost Evoke spinal cord stimulation offering
Saluda Medical has finalised US$125 million in equity financing, with the proceeds being used in part to operationalise and scale commercialisation of the company’s Evoke spinal...
First surgical cases completed using Life Spine’s Dyna-Link titanium with barb...
Life Spine has announced that the first surgical cases using its Dyna-Link titanium device with barb fixation have been completed. The Dyna-Link titanium stand-alone...
SurGenTec receives FDA clearance for ION screw spine fixation implant
SurGenTec has received clearance from the US Food and Drug Administration (FDA) for ION screw, its proprietary standalone spine fixation implant which can be...
Cannabis can be an effective treatment option for back pain but...
The use of cannabis can be an effective option to treat back pain with an acceptable side effect profile but long-term follow-up is lacking...
SpineUp receives 510(k) FDA clearance for Romero cervical cages
SpineUp has been granted 510(k) clearance by the US Food and Drug Administration (FDA) for both its Romero self-anchored cervical cage and Romero cervical...
Robot-assisted and augmented reality-assisted thoracolumbar instrumentation “advantageous for both patients and...
Robot-assisted and augmented reality-assisted thoracolumbar instrumentation is advantageous for both patients and surgeons but, as the technology progresses and indications expand, it remains essential...
Augmented reality technology has a “bright future” in spine surgery
Alexander Satin, a spine surgeon at the Texas Back Institute (Frisco, USA), speaks to Spinal News International about the reasons why he uses augmented...
First participants enrolled in ONWARD’s LIFT Home study
ONWARD has begun enrolment in the LIFT Home study, which is designed to examine the safety and performance of its ARCEX Therapy for spinal cord...
3Spine raises US$33 million in Series C funding round
3Spine has raised US$33 million in an oversubscribed Series C private offering, the proceeds of which will be used to fund a Phase 2...
Obese patients still benefit from minimally invasive surgery for adult spinal...
Obese patients who undergo minimally invasive surgery (MIS) for adult spinal deformity (ASD) have less correction of their deformity, worse quality-of-life outcomes, more implant...
Saluda Medical receives FDA approval for the Evoke spinal cord stimulation...
Saluda Medical has announced that it has received full approval from the US Food and Drug Administration (FDA) for the Evoke spinal cord stimulation (SCS)...
Accelus announces first successful surgeries using Remi robotic navigation with LineSider...
Accelus has announced the successful completion of the first cases utilising its Remi robotic targeting and navigation platform with its LineSider posterior fixation system.
Neurosurgeon...
Life Spine announces first surgical case of ProLift Lateral HELO fixated
Life Spine has announced the first surgical case of the ProLift Lateral HELO fixated expandable lateral spacer system.
The ProLift Lateral HELO fixated with Osseo-Loc surface...
VySpine announces FDA clearance for LumiVy lumbar IBF system
VySpine has received 510(k) clearance from the US Food and Drug Administration (FDA) for its LumiVy lumbar IBF system which is designed for use...
VUZE Medical secures new global patents
VUZE Medical has received additional patents for its VUZE system in the US, Europe and China. Using proprietary image processing, the VUZE system is a...
Vertebral body tethering can help prevent fusion surgery of skeletally immature...
Vertebral body tethering (VBT) is a safe and efficacious technique in preventing skeletally immature idiopathic scoliosis patients from having fusion surgery, new research—published by...
CoreLink announces FDA clearance of Fusation 3D printed cervical anchor
CoreLink has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the addition of Fusation anchors to...
Waypoint Orthopedics appoints Andrew Iott to board of directors
Waypoint Orthopedics has appointed Andrew Iott, who has more than 20 years of experience in the medical device industry, to its board of directors.
Iott has...
Quantitative computed tomography ‘should become gold standard’ for detecting spinal osteoporosis
Quantitative computed tomography (Q-CT) is a better alternative and should replace dual X-ray absorptiometry (DXA) as the gold standard for detecting spinal osteoporosis. This...
Why the Pulse platform is a “game-changer” for spine surgery
This advertorial is sponsored by NuVasive.
The field of spine surgery has seen some major developments over the past few years, with new technological advances...
DiscGenics reveals positive interim data of cell therapy for degenerative disc...
DiscGenics has announced positive interim data from its ongoing phase 1/2 clinical trial of IDCT (rebonuputemcel), an allogeneic injectable discogenic cell therapy for degenerative...
Spinal News International’s top 10 most popular stories of February 2022
Anterior lumbar interbody fusion versus transforaminal lumbar interbody fusion for treating those with isthmic spondylolisthesis was our top story in February, closely followed by...
4WEB Medical launches new hyperlordotic lateral implant range
4WEB Medical has announced the launch of an array of hyperlordotic lateral implants, utilising the firm’s proprietary Truss Implant Technology.
Brad Prybis, an orthopidst at...
Underweight patients at greater risk of postoperative adverse events following stand-alone...
Patients who are underweight are more likely to experience postoperative adverse events following stand-alone anterior lumbar interbody fusion (ALIF) than those who have either...
VySpine and Oxford Performance Materials join forces to develop spinal implants
VySpine has entered into a partnership agreement with Oxford Performance Materials (OPM), enabling the pair to collaborate to develop spine fusion products using OPM’s...
Orthofix launches Opus BA for cervical and lumbar spine fusion
Orthofix has announced the full market launch of Opus BA, a synthetic bioactive bone graft solution for cervical and lumbar spine fusion procedures.
Available in putty...
Cerapedics completes enrolment of pivotal IDE study for P-15L bone graft
Cerapedics has announced that it has completed enrolment of the ASPIRE study—a pivotal US Food and Drug Administration (FDA) investigational device exemption (IDE) study—which...
Research outlines transfusion guidelines for adult spine surgery
For adult spine surgery patients, red blood cell transfusion should be avoided if haemoglobin (Hb) numbers remain above 9g/dl in the intraoperative period and...
Theradaptive wins additional FDA breakthrough designation for spinal fusion implant
Theradaptive has announced that the US Food and Drug Administration (FDA) has granted breakthrough medical device designation for its OsteoAdapt SP spinal fusion implant...
Neo Medical closes US$20.6M financing round
Neo Medical has announced the closure of a US$20.6M financing round, the proceeds of which will be used to support the accelerated commercial deployment, with...
Full-endoscopic transforaminal discectomy is “an effective alternative” to open microdiscectomy in...
Percutaneous transforaminal endoscopic discectomy (PTED) can be considered as an effective alternative to open microdiscectomy in treating sciatica. This is the key finding from...
Companion Spine raises US$55 million to further develop and market its...
Companion Spine has raised US$55 million in a Series A financing round, with the money going towards the development and commercialisation of its range...
First surgical procedures performed in the USA with the Jazz PF...
Implanet has announced that the first surgeries have been conducted in the USA with its Jazz PF tethering implant.
Jazz PF is designed to allow...
SCS for postlaminectomy syndrome associated with minor reductions in opioid use,...
Spinal cord stimulation (SCS) for postlaminectomy syndrome (PLS) is associated with small, clinically questionable opioid discontinuation and a lower rate of new opioid use...
No proven benefit of non-invasive electrical stimulation as adjunct to fusion
Non-invasive electrical stimulation as an adjunct to fusion does not appear to offer any meaningful increase in fusion rate, although further and better quality...
AxioMed closes in on FDA approval of its lumbar viscoelastic total...
AxioMed has moved closer towards achieving US Food and Drug Administration (FDA) approval of its lumbar viscoelastic total disc replacement after submitting PMA Module...
ALIF offers superior outcomes to TLIF for the treatment of L5-S1...
Anterior lumbar interbody fusion (ALIF) generates greater segmental lordosis, regional lordosis, and restoration of disc height compared to transforaminal lumbar interbody fusion (TLIF) when treating isthmic...
Empirical Spine inches closer to LimiFlex US launch
Empirical Spine has recently achieved a number of clinical, reimbursement and regulatory milestones in the past 12 months that have helped move its LimiFlex...
Spinal News International’s top 10 most popular stories of January 2022
Research on artificial disc replacement following anterior decompression tops January's Top 10 Spinal News International articles. Also popular this month were findings on the...
Meta-analysis highlights benefits of reducing endotracheal tube cuff pressure following retractor...
Reducing endotracheal tube cuff pressure (ETTCP) following retractor placement in anterior cervical fusion surgery may be a protective measure to decrease the severity of...
SpineGuard files 510(k) dossier for clearance of its Threaded PediGuard for...
SpineGuard has announced the filing of its 510(k) regulatory dossier with the US Food and Drug Administration (FDA), as it seeks authorisation to commercialise its...
VySpine announces FDA clearance for ClariVy cervical IBF system
VySpine has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its ClariVy cervical interbody fusion (IBF)...
AO Spine launches new Guest Blog
AO Spine has unveiled its new Guest Blog, which aims to share knowledge and improve patient care by allowing clinicians, scientists, influencers, thought leaders, and...
Implanting standalone expandable cages following anterior cervical corpectomy and fusion is...
The use of a standalone expandable cage in the cervical spine after one or two-level anterior cervical corpectomy and fusion (ACCF) without additional posterior...
Bone Solutions launches injectable bone void filler
Bone Solutions has announced the commercial launch of Mg OSTEOINJECT, an injectable bone void filler which is designed to promote bone repair and regeneration...
SetBone Medical closes US$1.6 million financing round
SetBone Medical, a company that has developed a novel bone cement for the treatment of spinal vertebrae fractures and other orthopaedic procedures, has announced...
Medtronic announces FDA approval of spinal cord stimulation therapy for treating...
Medtronic has received US Food and Drug Administration (FDA) approval of its Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulator for the treatment of chronic...
NGMedical appoints new president and general manager of its US business
NGMedical has announced the addition of Mitch White as president and general manager, a role in which he will lead all aspects of the...
Adult spinal deformity surgery associated with increased productivity and decreased work...
Adult spinal deformity (ASD) surgery is associated with increased productivity and decreased absenteeism from both work and school. These are the key findings from...
Orthofix and nView medical announce partnership and investment agreement
Orthofix and nView medical have announced a partnership and investment agreement to jointly develop and co-market the nView systems with Orthofix cervical spine and...
Surgalign receives FDA clearance for AI-driven HOLO Portal system for spine...
Surgalign Holdings has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its HOLO Portal surgical guidance system for...
Risdiplam associated with significant improvements in motor function in type 2...
The use of once-daily risdiplamin in type 2 and non-ambulant type 3 spinal muscular atrophy (SMA) patients leads to a significant improvement in motor...
Vast majority of scoliosis patients who develop a major neurological deficit...
Almost 90% of scoliosis patients who develop a major neurological deficit after corrective surgery either partially or completely recover within two years, a recent...
Amber Implants closes US$10milliom Series A financing round
Amber Implants has announced the successful closing of its US$10 million Series A financing round, the funds of which will be used to boost the company’s...
VUZE system gets US FDA 510(k) clearance
VUZE Medical has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its VUZE system—a software-only solution that overlays...
Whole spine MRI should be used to assess children with suspected...
Whole spine magnetic resonance imaging (MRI) rather than cervical spine MRI should be used in children with suspected abusive head trauma in order to...
FDA grants StimuLux system breakthrough device designation
Wavegate Corporation has announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its StimuLux optical reflectometry system for...
DTM spinal cord stimulation endurance therapy associated with meaningful pain relief...
Differential Target Multiplexed (DTM) spinal cord stimulation (SCS) endurance therapy provides meaningful pain relief according to three-month data from the DTM-LE trial—the findings of...
First implant in integrated spinal fusion and DRG neuromodulation proof-of-concept study
SynerFuse has announced the first implantation in the company's proof-of-concept study, which will evaluate the safety and tolerability of simultaneously implanting spinal fusion hardware and...
Inspan interspinous plate fixation device granted FDA clearance for fusion and...
Inspan LLC has announced that it has received US Food and Drug Administration (FDA) clearance for its interspinous plate fixation device to be used...
Nvision Biomedical Technologies and Watershed Idea Foundry launch first 3D-printed anterior...
Nvision Biomedical Technologies and Watershed Idea Foundry have received FDA clearance for what they say is the first-ever completely additive manufactured titanium anterior cervical plate, the Quantum...
Artificial disc replacement has no long-term benefit over fusion following anterior...
There is no clear benefit associated with artificial disc replacement (ADR) compared with fusion surgery when it comes to patient satisfaction, sustainability, and protection...
Orthofix appoints Thomas West to board of directors
Orthofix has announced that Thomas West has been appointed to the company’s board of directors as well as to its compensation and talent development...
VySpine bags FDA clearance for the VySpan posterior cervical thoracic system
VySpine has received 510(k) clearance from the US Food and Drug Administration (FDA) for the VySpan posterior cervical thoracic (PCT) system. The system features...
Spinal News International’s top 10 most popular stories of December 2021
A whole host of research, on topics ranging from sciatica surgery and spinal cord stimulation to vertebral augmentation and laminectomy plus instrumented fusion, dominated...
NuVasive announces expanded indications of use for Attrax Putty
NuVasive has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for expanded indications of use for Attrax Putty with its...
Proclaim XR spinal cord stimulation system gets expanded MRI compatibility boost
Abbott has announced that the US Food and Drug Administration (FDA) has approved new expanded magnetic resonance imaging (MRI) compatibility for its Proclaim XR spinal cord...
Postoperative neurological deficit linked to intraoperative somatosensory-evoked potential changes
Patients who have postoperative neurological deficit following lumbar spine surgery are 22 times more likely to have exhibited intraoperative somatosensory-evoked potential (SSEP) changes. This...
Increased curve flexibility is ‘strongly associated’ with increased initial in-brace correction...
A recently published systematic literature review has suggested that increased curve flexibility is strongly associated with initial in-brace correction in patients with idiopathic scoliosis...
Camber Spine unveils new chief medical officer
Camber Spine has named Edward Vresilovic—a man with more than 36 years of experience in orthopaedic surgery—as its new chief medical officer.
A board-certified orthopaedic...
Surgical treatment for degenerative cervical myelopathy is associated with long-term improvements...
Surgical treatment for degenerative cervical myelopathy (DCM) leads to a satisfactory improvement of functional outcome which is maintained out to 10 years, a recent...
Enrolment completed for Up-LIFT pivotal trial of ARC Therapy for spinal...
ONWARD has announced that it has completed enrolment in the Up-LIFT study, a pivotal trial that aims to evaluate the safety and effectiveness of...
Laminectomy plus instrumented fusion associated with higher costs and no superior...
Surgical treatment with instrumented fusion as an adjunct to laminectomy is not associated with superior long-term clinical outcomes compared with laminectomy alone for patients...
Longer-term data needed to fully assess potential superiority of minimally invasive...
There is no clear superiority between minimally invasive posterior cervical foraminotomy (MIS-PCF) and either anterior cervical discectomy and fusion (ACDF) or cervical total disc...
Spire Orthopedic Partners recruits first chief marketing officer
Spire Orthopedic Partners has hired orthopaedic marketing executive Nicole Monsky as the company’s first chief marketing officer.
“We are thrilled to welcome Nicole to our...
Vertebral augmentation surgeries demonstrate positive clinical outcomes for cancer-related spinal compression...
Vertebral augmentation surgeries—such as vertebroplasty and kyphoplasty—for the treatment of cancer-related spinal compression fractures are associated with statistically significant positive outcomes, particularly when compared to nonsurgical...
Over-the-arch technique is safe and feasible for C1 screw fixation in...
The over-the-arch (OTA) technique is a safe and feasible alternative for C1 screw fixation in patients in whom conventional techniques cannot be employed, according...
Effect on leg pain is biggest factor for patients considering sciatica...
The effect on leg pain is the most important factor for patients when it comes to deciding whether or not to undergo surgery for...
Premia Spine appoints three new board advisors ahead of TOPS system...
Premia Spine has announced the appointment of three new advisors—Stephen Hochschuler, Peter Wehrly and Nicholas Pachuda—to its board of directors. Bringing decades of clinical,...
New research highlights importance of early surgery for those with chronic...
Patients with chronic sciatica secondary to lumbar disc herniation who receive delayed surgery following prolonged, standardised non-operative care have inferior outcomes to those who...
Spinal News International’s top 10 most popular stories of November 2021
Research presented at the Global Spine Congress annual meeting (3–6 November 2021, Paris, France), a video on the effects of Covid-19 on spine care...
Passive recharge burst spinal cord stimulation provides sustainable improvements in pain...
Passive recharge burst spinal cord stimulation (B-SCS) can alleviate pain intensity, psychological distress, and improve physical function and health-related quality of life out to two years,...
Spine Wave launches Defender anterior cervical plate and Stronghold C 3D...
Spine Wave has announced the launch of both the Defender anterior cervical plate and the Stronghold C 3D titanium interbody device featuring TiCell 3D...
Philips expands global presence of augmented reality spine navigation solution
Philips has announced that the first patients have been successfully treated using its 3D augmented reality (AR) spine navigation solution, ClarifEye, at Sant Joan...
Low education and low income are “clear independent contributors” to poorer...
Low educational attainment and low income status are clear independent contributors to poorer outcomes following lumbar spine surgery, a new study, published in The...
CoreLink announces commercial launch of CentraFix midline fixation system
CoreLink has announced the commercial launch and 510(k) clearance from the US Food and Drug Administration (FDA) for its CentraFix midline fixation system—which features...
Initial use of spinal manipulative therapy reduces adverse drug event risk...
The use of spinal manipulative therapy (SMT) as initial treatment of chronic low back pain (cLBP) in older patients is associated with a substantial...
Meta-analysis reveals key risk factors for postoperative urinary retention following spine...
Older age, male sex, benign prostatic hyperplasia, diabetes mellitus and a history of urinary tract infection are all risk factors for postoperative urinary retention...
First dualPortal endscopic spine procedure performed
Amplify Surgical has announced the completion of the first endoscopic spine procedure using its dualPortal solution—a novel two-portal endoscopic approach that the company says...
SeaSpine announces full commercial launch of the Admiral ACP system
SeaSpine has announced the full commercial launch of its Admiral ACP system—a spinal implant system which is designed to create a more efficient and...
New bone cutting technology from Surgify gets first surgical use
Finnish startup, Surgify, has announced that its bone cutting technology—which is designed to allow surgeons to perform operations on bones faster and safer—has been...
DePuy Synthes unveils next-generation power tool system for spine surgery
DePuy Synthes has launched its next-generation UNIUM power tool system which can be used in spine, thorax and small bone procedures.
Funda Haine, worldwide vice...
Novoron Bioscience raises US$3 million to boost neuroregeneration therapy for spinal...
Novoron Bioscience has secured US$3 million in seed funding which will go towards advancing the development of its of neuroregeneration therapy for spinal cord...
Greater patient support needed to tackle persistent opioid usage following lumbar...
Patients who are either persistent opioid users, or are at risk of developing persistent opioid use, should be identified and offered counselling and support...
Precise blood pressure control may aid patient recovery from spinal cord...
High or low blood pressure in patients undergoing surgery to repair a spinal cord injury may contribute to poorer outcomes and maintaining an optimal...
Neuroplast secures €10 million in funding to boost clinical development of...
Neuroplast has raised a total of €10 million in a Series B funding round, the money of which will be used to obtain conditional...
Theradaptive’s Osteo-Adapt SP spinal fusion implant granted FDA breakthrough device designation
Theradaptive has announced that the US Food and Drug Administration (FDA) has granted breakthrough medical device designation to its Osteo-Adapt SP Spinal Fusion implant...
Cortical bone trajectory technique shows “remarkable superiority” compared with traditional trajectory...
The use of the cortical bone trajectory (CBT) technique has not only shown similar intra-pedicular accuracy compared to traditional trajectory (TT) but also “remarkable...
Fewer surgical risks with robotic guidance than fluoroscopic guidance in adult...
Robotic guidance (RG) is associated with a lower risk of both surgical complications and revision surgery when compared with fluoroscopic guidance (FG) in adult...
Spineart announces IDE milestone and Australian partnership
Spineart has revealed that the 100th surgery has been performed in their combined single-level and two-level US investigational device exemption (IDE) clinical trials of...
New CPT add-on code accepted for second level of lumbar total...
In an effort to increase the availability of two-level lumbar total disc replacement (TDR) to individuals experiencing degeneration of the intervertebral discs, the American...
MedTech Insights: Covid-19 has “served as a catalyst” for a shift...
Carlton Weatherby (Memphis, USA), vice president and general manager of spine and biologics at Medtronic, talks to Spinal News International about his own early...
Long-term outcomes for minimally invasive TLIF in elderly patients are comparable...
Elderly patients undergoing minimally invasive (MIS) transforaminal lumbar interbody fusion (TLIF) not only had similar perioperative outcomes compared to younger patients, but also achieved...
HSS scientist awarded $6 million in grants for disc degeneration and...
A scientist at Hospital for Special Surgery (HSS), Chitra Dahia (New York, USA) has received two National Institutes of Health (NIH) grants totalling $6 million for translational...
Spinal Elements announces first clinical use of the Lucent 3D lumbar...
Spinal Elements has announced that the first clinical cases using the Lucent 3D lumbar interbody system have been successfully completed. The first cases were...
Neuroplast announces successful clinical Phase I trial with Neuro-Cells stem cell...
Dutch biotech company, Neuroplast, and the Hospital Nacional de Parapléjicos de Toledo in Spain have announced positive clinical Phase I results after analysis of ten patients...
HAPPE Spine raises US$3.35 million to launch new interbody spinal fusion...
HAPPE Spine has announced the closure of a US$3.35 million Series A funding round, the proceeds of which will be used to help launch...
Table-mounted retractors can improve operative efficiency without leading to inferior outcomes
With proper application, the use of a table-mounted retractor can help improve operative efficiency without leading to inferior outcomes in patients undergoing anterior cervical...
Minimally invasive spine surgery associated with significantly lower incidence of dural...
Minimally invasive spine surgery results in a significantly lower incidence of dural tear and complications when compared to open surgery in patients with degenerative...
Existing guidelines to change as research shows early surgical decompression following...
Surgical decompression within 24 hours of acute spinal cord injury (SCI) improves neurological recovery, and current guidelines on surgical management of SCI are being reviewed...
Premia Spine’s Tops spinal arthroplasty system yields positive patient outcomes
Intermediate clinical study results, which were presented at the Society for Minimally Invasive Spine Surgery (SMISS) annual meeting (28–30 October, Las Vegas, USA) by...
Surgery is associated with a greater likelihood of neurologic recovery in...
Brian Goh (Boston, USA) speaks to Spinal News International about the results of a study that aimed to better understand the impact of surgical...
Erector spinae plane block is effective in reducing postoperative pain and...
Erector spinae plane block (ESPB) is effective in decreasing both postoperative pain intensity and postoperative opioid consumption after spine surgery, according to findings from...
Early surgical decompression is recommended for patients with foot drop in...
Early surgical decompression after foot drop is beneficial in terms of recovery rate and neurological improvement when compared with late surgery. This is according...
NeoSpine first to offer spinal cord stimulation for treatment of painful...
NeoSpine is now offering spinal cord stimulation (SCS) procedures for the treatment of painful diabetic neuropathy (PDN) via its HFX system—a newly approved nondrug treatment...
SeaSpine announces limited commercial launch of Mariner MIS Wayfinder
SeaSpine has announced the limited commercial launch and completion of initial surgeries of the Mariner MIS Wayfinder—a novel, one-step, k-wireless screw delivery system for...
Bioventus looks to expand spinal reach with Misonix acquisition
Bioventus has completed the acquisition of Misonix—a provider of minimally invasive therapeutic ultrasonic technologies and regenerative medicines that are designed to enhance clinical outcomes—...
Study supports clinical effectiveness of STALIF C-Ti integrated interbody system
The STALIF C-Ti integrated cage-screw implant (Centinel Spine) has demonstrated statistically significant and clinically meaningful improvements in all available patient reported outcome scores out...
Subcutaneous intrathecal catheter provides reliable administration of nusinersen for SMA patients
For spinal muscular atrophy (SMA) patients with complex spine anatomy, the subcutaneous intrathecal catheter (SIC) allows for reliable outpatient administration of nusinersen that results...
Medtronic Canada unveils Mazor X, the first dedicated robotic spinal surgery...
Medtronic Canada has announced the commercial launch of the Mazor X system for robotic-guided spine surgery. The Mazor X platform offers a fully integrated...
Improved implants, patient selection and long-term data needed to assess true...
Anterior vertebral body tethering (AVBT) of skeletally immature patients is associated with satisfactory deformity correction in the majority of cases, new research has found....
CMS grants transitional pass-through payment for Carlsmed’s aprevo personalised interbody devices
Carlsmed has announced that the Centre for Medicare and Medicaid Services (CMS) has granted its aprevo personalised interbody devices a transitional pass-through (TPT) payment...
Lateral lumbar interbody fusion is associated with lower adjacent segment motion...
The choice of lumbar interbody fusion approach influences adjacent segment motion in a cadaveric model, according to new research published in the journal Spine,...
NuVasive launches latest porous PEEK implant for posterior spine surgery
NuVasive has announced the launch of its Cohere TLIF-O implant as well as the upcoming launch later this year of the Cohere TLIF-A implant....
Eurospine 2021: Artificial intelligence can “accurately and reliably” detect thoracolumbar fractures...
Artificial intelligence (AI) has the capability to accurately and reliably detect thoracolumbar fractures on sagittal radiographs, according the findings from a retrospective study that...
Eurospine 2021: Transforaminal epidural steroid injection “should be first invasive treatment...
Transforaminal epidural steroid injection (TFESI) should be considered as a first invasive treatment option, up to 12 months, for patients with sciatica secondary to...
Eurospine 2021: Surgery for adult spinal deformity is associated with long-term...
Research presented at the 2021 Eurospine annual meeting (6–8 October, Vienna, Austria) shows that there is strong evidence to suggest that surgery for adult...
Life Spine receives FDA 510(k) clearance for ProLift micro expandable spacer...
Life Spine has received clearance from the US Food and Drug Administration (FDA) to market the ProLift micro Expandable Spacer System.
ProLift micro is designed...
ReVivo Medical raises $2 million for FDA-sanctioned clinical trial
ReVivo Medical has announced that it has raised $2 million which will allow it to complete the 500 surgical procedures of its clinical trial.
Gary...
SpineGuard secures Brazilian clearance for DSG Connect products
SpineGuard has received clearance from ANVISA (Agência Nacional de Vigilância Sanitária), the government regulatory authority, for authorisation to sell its Dynamic Surgical Guidance (DSG) Connect products...
Amber Implants’ VCFix spinal system receives US FDA breakthrough device designation
Amber Implants has announced that its VCFix spinal system, which aims to improve the treatment of vertebral fractures, has been granted breakthrough device designation...
First commercial cases completed using Pulse platform
Michael Kachmann and Zachary Tempel from Mayfield Brain & Spine (Norwood, USA) and Paul Holman from Houston Methodist Hospital (Houston, USA) have successfully completed...
Efficacy of liposomal bupivacaine in spine surgery indicated but high quality...
Liposomal bupivacaine (LB) may safely decrease postoperative opioid requirements, pain scores, and length of stay in patients undergoing spine surgery, but greater evidence is needed to...
Nexxt Spine announces commercial launch of the Nexxt Matrixx standalone cervical...
Nexxt Spine has announced the commercial launch of the Nexxt Matrixx cervical standalone system—a 3D laser printed titanium implant that features varying pore sizes...
Navigation in adult spinal deformity patients leads to an increased risk...
Use of navigation in patients undergoing surgery for adult spinal deformity (ASD) is associated with higher operative time and transfusion compared to conventional surgery, suggesting that navigation...
Spineology unveils “first-of-its-kind” Duo Ti expandable interbody fusion procedure
Spineology has unveiled its Duo Ti expandable interbody fusion procedure, which combines the company’s proprietary mesh technology with porous titanium in order to deliver a...
Joimax launches NAVENTO navigation endoscopic tower
Joimax has announced the global launch of its NAVENTO navigation endoscopic tower, which can be used for endoscopic spine surgery and includes settings that...
Precision Spine launches the Dakota ACDF standalone system
Precision Spine has announced the launch of the Dakota ACDF standalone system for the treatment of degenerative disc disease (DDD).
The Dakota ACDF system features...
Camber Spine launches SPIRA-P and SPIRA-T implants for national distribution
Camber Spine has initiated the full US launch of its SPIRA-P posterior lumbar spacer and SPIRA-T oblique posterior lumbar spacer devices.
News of launch comes...
Revision PCDF has lower risk of ICU stay but higher hospitalisation...
Patients undergoing revision posterior cervical discectomy and fusion (PCDF) procedures had a decreased risk of required intensive care unit (ICU) stay but greater risk...
Patients experience improvement in pain during sexual activity at one year...
A large proportion of patients undergoing surgery for lumbar spinal stenosis (LSS) experienced an improvement in pain during sexual activity at one year, according to the results of a...
ADVERTORIAL: BEE® cage implant optimises bone ingrowth and fusion while reducing subsidence
This advertorial is sponsored by NGMedical.
Pierce Nunley, director of the Spine Institute of Louisiana (Shreveport, USA) and associate professor at LSUHSC Department of Orthopaedic Surgery, talks to Spinal News...
Biedermann Motech further expands MOSS VRS pedicle screw platform
Biedermann Motech has announced that its MOSS VRS pedicle screw platform is now available as a fully modular solution.
The MOSS VRS system features Next Generation...
Joimax receives FDA clearance to market 3D-printed titanium cages in the...
Joimax has received US Food and Drug Administration (FDA) clearance to market the EndoLIF Delta-Cage and EndoLIF DoubleWedge-Cage—both of which are intended for intervertebral...
Intelivation Technologies receives FDA approval for Advantage-C PEEK cervical interbody fusion...
Intelivation Technologies has received US Food and Drug Administration (FDA) 510(k) clearance of the Advantage-C PEEK cervical interbody fusion device, which is designed to be...
Spinal Elements announces full commercial launch of Luna XD and Orbit...
Spinal Elements has announced the full commercial launch of the Luna XD multiexpandable lumbar interbody fusion device and Orbit articulating discectomy systems.
Luna XD and Orbit...
PEEK-on-ceramic TDR is a ‘viable alternative’ to ACDF for single-level symptomatic...
Polyetheretherketone (PEEK)-on-ceramic total disc replacement (cTDR) is a viable treatment for symptoms related to cervical disc degeneration and offers similar or superior outcomes compared with fusion, according...
Study indicates increased prevalence of depression in patients with degenerative spine...
There is an increased prevalence of depression in patients with degenerative spine disease (DSD) and, considering the relationship between depression and poor surgical outcomes,...
Boston Scientific launches FAST—a new therapy for spinal cord stimulation
Boston Scientific has announced the European launch of FAST—a new fast-acting sub-perception therapy that the company says is clinically proven to demonstrate significant and...
Patient education and new technologies can help reduce unnecessary and costly...
In an effort to reduce unnecessary patient interactions and associated costs following lumbar surgery, providers should utilise virtual visits or new technologies to monitor patient's postoperative...
MiRus receives FDA clearance for IO Expandable Lumbar Interbody
MiRus has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its IO Expandable Lumbar Interbody, a device which...
New study demonstrates long-term efficacy of prodisc L total disc replacement
Centinel Spine has announced findings of a new study that it says strongly support the long-term safety and effectiveness of its prodisc L total disc replacement...
NuVasive announces new executive leadership roles
NuVasive has announced new executive leadership roles, with the appointments designed to strengthen the firm’s innovation and go-to-market teams while furthering the company's growth.
Massimo...
Intelivation Technologies receives FDA approval for its Golden Isles Pedicle Screw...
Intelivation Technologies has announced that the company has achieved US Food and Drug Administration (FDA) 510(k) clearance of its Golden Isles Pedicle Screw System.
The Golden Isles...
OsteoCentric Technologies secures $30m funding
OsteoCentric Technologies has announced USD$30million in growth capital funding that it says will enable new product introductions which address implant instability as well as...
Intraoperative freehand erector spinae plane block is effective and can reduce...
Intraoperative freehand erector spinae plane block (ESPB) as part of multimodal analgaesia is effective and, for posterior instrumented patients with spondylolisthesis, it can relieve...
Arthroplasty and fusion offer similar results out to five years for...
Arthroplasty and fusion are comparable treatment options for cervical radiculopathy and have similar long-term efficacy, findings from a randomised controlled trial (RCT) have shown.
The data, which were...
Cycling accidents are the most common cause of sports-related traumatic spine...
Accidents involving cycling are by far the most common cause of sports-related traumatic spine injuries (TSIs) in the USA, according to new research published...
Auctus Surgical granted FDA breakthrough device designation for vertebral body tethering...
Auctus Surgical has received US Food and Drug Administration (FDA) breakthrough device designation for its vertebral body tethering (VBT) system, which the company says...
Stryker launches SurgiCount+ safety-sponge system
Stryker has announced the launch of SurgiCount+ safety-sponge system—its next-generation surgical sponge-counting technology.
SurgiCount+ allows healthcare providers to count and scan sponges and connect to...
Decompression alone is non-inferior to decompression with instrumented fusion out to...
Spinal decompression alone is non-inferior to decompression with instrumented fusion over a period of two years in patients with degenerative lumbar spondylolisthesis, according to...