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, the company’s US Food and Drug Administration (FDA) cleared personalised surgical devices. The Series B funding...
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 and fusion (ACDF). As such, the technology can be used to support clinical decision-making and...
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 device. HealthOST is an artificial intelligence (AI) software that aims to provide qualitative and quantitative analysis...
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), a recent meta-analysis has shown. The research, published by Cheng-Li Lin (National Cheng Kung University Hospital,...
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 designed to stimulate the spinal cord to restore movement and autonomic function for people with...
CTL Amedica has been granted an official patent by the United States Patent and Trademark Office for its KLIMT expandable lumbar interbody fusion cage design. Named after the famous Austrian artist Gustav Klimt, the KLIMT expandable lumbar interbody fusion cage...
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, lumbar, and sacral spine while awaiting bony fusion to occur. The implant is designed for attachment...
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 the benefits of surgery for ASD remain durable long term. This is the key message...
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 of spinal fusion cages—which features a new ultra-low profile with titanium at the bony interface. Chris...
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 cervical plates and interbody cages. Gary Mittleman, president and CEO of ReVivo Medical, said: “The procedures...
Wenzel Spine has announced that its board of directors has appointed Warren Neely as chairman of the board and William (Bill) Wilson as president and chief executive officer following the unexpected passing in March this year of Wenzel Spine’s...
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 routinely need pre-transfusion testing. This is according to new research, published recently in the journal...
To celebrate its 20th anniversary, the US National Spine Health Foundation (NSHF) has announced the 50 top spine experts who comprise its medical and scientific and scientific board and who help to promote the foundation’s mission to improve spinal...
Surgalign has announced that its HOLO Portal surgical guidance system has officially entered clinical use, with the first procedure performed at Indiana Spine Hospital (Carmel, USA) by Mario Brkaric, a board-certified orthopaedic surgeon. According to Surgalign, the HOLO Portal system...
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 in the US. New international investors in this expanded round include the Greek technology venture capital...
Poor cartilage endplate (CEP) composition plays a significant role in disc degeneration severity and can affect disc health both with and without deficits in vertebral perfusion. This is the key message to come out of new research published in...
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 system that incorporates ChoiceSpine’s proprietary BioBond porous structure technology. The system features four titanium, dual-threaded...
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 (University of Cincinnati College of Medicine, Cincinnati, USA) et al—has found. The retrospective single-centre study showed...
Camber Spine has announced that it has received a notice of allowance from the United States Patent and Trademark Office (USPTO) for its Variant Retractor technology. The Variant Retractor is a tool designed to provide flexible spacing support for a...
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 disc (NuVasive) compared to anterior cervical discectomy and fusion (ACDF) in appropriately selected patients with...
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 whether or not endoscopic surgery will become the standard of care for spinal decompression. Quality...
Empirical Spine recently submitted premarket approval (PMA) Module II in the US Food and Drug Administration (FDA) approval process for its LimiFlex Dynamic Sagittal Tether (DST). LimiFlex is an investigational device targeting grade one lumbar degenerative spondylolisthesis patients with spinal...
Medtronic has announced that Laura Mauri has been appointed as the company’s chief scientific, medical and regulatory officer. This appointment adds to Mauri's prior responsibilities as chief clinical and regulatory officer, aligning and integrating the company's scientific, medical, clinical research...
Dietary vitamin D supplementation can potentially offer a benefit to those with adolescent idiopathic scoliosis (AIS), according to new research which found that a significantly higher occurrence and severity of scoliosis induced by a vitamin D deficient diet suggested...
In patients with early onset scoliosis (EOS), implants with a lower radius of curvature (ROC) are associated with an increased risk of clinically significant proximal junctional kyphosis (PJK). This is the key finding from new research which was presented...
Although there was no difference in patient reported outcomes (PROs) between those who underwent surgery for decompression with instrumented posterolateral fusion (IPLF) and those with uninstrumented posterolateral fusion (UPLF) at two-year follow-up, patients who underwent UPLF had a higher...
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. The company now operates in a total of 17 countries and are currently working towards...
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 tethered and the preoperative triradiate cartilage is open, a recent study has found. The results of...
Isto Biologics has acquired TheraCell as is looks to increase its focus on offering solutions for surgical and clinical care procedures within spine, orthopaedics, and sports medicine. Don Brown, CEO of Isto Biologics, said: “We are thrilled to add TheraCell’s...
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 for anterior approach instrumented spine surgery. Stéphane Bette, co-founder and deputy CEO of SpineGuard, said: “SpineGuard’s...
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. The financing will also go towards developing machine learning software tools for assisting engineers with...
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 lumbar interbody fusion (ALIF) system. According to the company, El Capitan Oblique was specifically designed to...
Following the recent introduction of key data supporting the use of high-frequency spinal cord stimulation (SCS) in the treatment of non-surgical refractory back pain (NSRBP), Leonardo Kapural (Carolinas Pain Institute, Winston-Salem, USA) talks to Spinal News International's sister title,...
Minimally invasive image-guided therapy startup, SpinaFX Medical, has announced the appointment of Kieran Murphy (University Health Network , Toronto, Canada) as chief medical officer and member of the board of directors. SpinaFX Medical CEO, Jeff Cambra, said: “ Murphy has...
Hospitalised patients with vertebral fragility fractures (VFF) represent a significant number, cost and use of bed days in England, however those who had early vertebral augmentation had a significantly shorter length of hospital stay. This is according to 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 “promising” but longer-term data are needed, new research suggests. The results of a prospective study, which...
Although early mobilisation after repaired incidental dural tears has similar major complication and reoperation rates compared to later mobilisation, it does, however, significantly decrease the risk of minor complications and length of hospitalisations. This is according to a new...
 David Cumming, the current president of the British Association of Spine Surgeons (BASS), speaks to Spinal News International about some of the main messages and key themes to come out of this year’s meeting (23–25 March 2022; Belfast, UK),...
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 caused by degenerative disc disease (DDD), has announced the completion of a US$13 million Series B equity...
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 International in March. It was closely followed by an advertorial on the benefits of the...
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 used to help launch an interbody spinal fusion implant, with a focus on completing final...
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 of whether or not endoscopic surgery will eventually become the standard of care for spinal...
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 damage to the central nervous system after sustaining acute traumatic spinal cord injury (TSCI). The trial...
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 is described as an experienced medical device executive with 23 years’ global experience who retired...
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 with asymptomatic castration-resistant prostate cancer with spinal metastasis, according to data from the PROMPTS trial,...
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 delivery options in the US orthopaedic market. According to Biocomposites, the genex bone graft substitute is...
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 cord simulation (SCS) system for chronic pain. The equity financing was led by existing investor Redmile...
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 anterior lumbar system is a zero-profile, standalone device that the company says offers surgeons a...
SurGenTec has received clearance from the US Food and Drug Administration (FDA) for ION screw, its proprietary standalone spine fixation implant which can be used to treat a variety of pathologies throughout the spine from C2-S1. According to SurGenTec, the...
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 and more evidence is needed to allow healthcare providers to confidently recommend cannabis therapy for...
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 cage—the company’s first product range. The Romero self-anchored cervical cage and Romero cervical cage are made...
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 to continue investigations of both in order to validate meaningful benefit over conventional instrumentation techniques...
Alexander Satin, a spine surgeon at the Texas Back Institute (Frisco, USA), speaks to Spinal News International about the reasons why he uses augmented reality (AR) in his practice. He outlines some of the key benefits as well as...
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 injury (SCI) when used in a home setting. ONWARD’s ARCEX Therapy is externally delivered programmed stimulation...
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 clinical study of its BalancedBack total joint replacement procedure in the USA. The company’s MOTUS device,...
A spinal cord stimulation (SCS) system capable of simultaneously delivering multiple treatment modalities has produced a sustained improvement in outcomes in a randomised controlled trial (RCT) involving chronic pain patients. Two-year findings from this study—the COMBO (Combining mechanisms for...
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 complications and infections, and an increased rate of revision surgery compared with their non-obese counterparts,...
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) system, which is indicated for the treatment of chronic intractable pain of the trunk and/or...
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 and Accelus chief robotics officer, Kevin Foley, who was also a key contributor in the...
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 technology offers a micro invasive solution for lateral lumbar interbody fusion, say Life Spine. The company...
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 after lumbar discectomy in fusion procedures. The LumiVy lumbar IBF system features lumbar interbody fusion devices...
Medtronic has announced that it has entered into a contract with Vizient to add Touch Surgery Enterprise, an AI-powered surgical video management and analytics platform for the operating room (OR), to Vizient's offerings. In a press release, Medtronic said that...
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 software-only solution that overlays a graphical representation of tools seen in intra-operative 2D images onto...
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 Darren Lui (St. George’s Hospital, London, UK) et al in the Bone and Joint Open...
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 the company’s F3D-C2 cervical stand-alone fusion system.  According to CoreLink, the Fusation anchors are an ideal...
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 worked in various product development and executive functions throughout his career. Most recently he was...
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 is according to a recent prospective comparative study, the results of which were published in...
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 paving the way for more accurate and reproducible procedures which, in turn, has ultimately helped...
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 disc disease (DDD). The interim results of the study—which includes 60 participants and is designed to...
Anterior lumbar interbody fusion versus transforaminal lumbar interbody fusion for treating those with isthmic spondylolisthesis was our top story in February, closely followed by further new research, this time on how effective full-endoscopic transforaminal discectomy is as an alternative...
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 Tanner Medical Center (Carollton, USA) who conducted the first procedure, said: “The application of 4WEB's...
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 a normal, overweight or even obese body mass index (BMI), new research published by Jonathan...
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 patented OsteoFab PEKK technology. VySpine is the designer of the OsteoVy PEKK lattice, which will be...
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 and strip formulations, Opus BA can be used to fill bone voids or gaps in...
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 will evaluate the safety and efficacy of P-15L bone graft for use in transforaminal lumbar...
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 8g/dl in the direct postoperative period. This is according to recent research, published by Umaru...
Theradaptive has announced that the US Food and Drug Administration (FDA) has granted breakthrough medical device designation for its OsteoAdapt SP spinal fusion implant indicated for posterolateral spinal fusion to treat degenerative disc disease, spondylolisthesis, or retrolisthesis. This marks the...
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 a particular focus on the US market, of the company’s ADVISE augmented reality (AR) platform...
Percutaneous transforaminal endoscopic discectomy (PTED) can be considered as an effective alternative to open microdiscectomy in treating sciatica. This is the key finding from new research published in the British Medical Journal by Pravesh Gadjradj (Weill Cornell, Brain and Spine...
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 of minimally invasive diagnostic and therapeutic solutions in the United States and internationally for the...
Nevro Corporation has announced online publication of 12-month data from the SENZA-NSRBP randomised controlled trial (RCT) in Journal of Neurosurgery: Spine. These data show that high-frequency 10kHz spinal cord stimulation (SCS) therapy results in profound improvements in non-surgical refractory back...
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 surgeons to create a soft landing of posterior spinal constructs in order to prevent proximal...
Spinal cord stimulation (SCS) for postlaminectomy syndrome (PLS) is associated with small, clinically questionable opioid discontinuation and a lower rate of new opioid use in patients who were previously opioid-naïve. These were the findings of new research, published by...
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 research is needed. This is according to findings of a meta-analysis which were recently published...
AxioMed has moved closer towards achieving US Food and Drug Administration (FDA) approval of its lumbar viscoelastic total disc replacement after submitting PMA Module II to the regulatory body. According to AxioMed, the clinical data supporting the device is strong...
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 spondylolisthesis. This is according to new research published in the journal Spine by Andrew Simpson...
Empirical Spine has recently achieved a number of clinical, reimbursement and regulatory milestones in the past 12 months that have helped move its LimiFlex Dynamic Sagittal Tether (DST) closer to market in the US. LimiFlex is an investigational device targeting...
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 link between adult spinal deformity and work and school absenteeism, as well as news on...
Reducing endotracheal tube cuff pressure (ETTCP) following retractor placement in anterior cervical fusion surgery may be a protective measure to decrease the severity of dysphagia and the odds of developing recurrent laryngeal nerve palsy (RLNP) or dysphonia, according to...
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 Threaded PediGuard device for anterior approach instrumented spine surgery. Stéphane Bette, co-founder and deputy CEO of...
Abbott announced today that UnitedHealthcare (UHC)—the largest private health insurance company in the USA—has updated its ‘Implanted electrical stimulator for spinal cord’ medical policy to expand patient access to Abbott’s dorsal root ganglion (DRG) neurostimulation devices for people suffering...
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) system which is designed for use in anterior cervical discectomy with fusion (ACDF) procedures.  Tom McLeer,...
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 solution providers to share their experiences and opinions. Asdrubal Falavigna, the current chairperson of AO Spine,...
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 fixation or anterior plating is a safe procedure that results in fusion, new research has...
Bone Solutions has announced the commercial launch of Mg OSTEOINJECT, an injectable bone void filler which is designed to promote bone repair and regeneration within insufficiency and micro fractures. According to Bone Solutions, Mg OSTEOINJECT is the first injectable bone...
The US Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies.   As per an FDA press release, the finalised version of the first of these two guidance...
SetBone Medical, a company that has developed a novel bone cement for the treatment of spinal vertebrae fractures and other orthopaedic procedures, has announced that it has closed an oversubscribed investment round of US$1.6 million. Investors in the round include The...
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 pain associated with diabetic peripheral neuropathy (DPN). Medtronic estimates that up to 800,000 US patients suffer...
NGMedical has announced the addition of Mitch White as president and general manager, a role in which he will lead all aspects of the company’s business throughout the US. White has held numerous positions within the spinal implant industry, with...
Adult spinal deformity (ASD) surgery is associated with increased productivity and decreased absenteeism from both work and school. These are the key findings from a recent retrospective cohort study, the findings of which were published by Wesley Durand (Johns...
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 paediatric limb deformity correction procedural solutions. The novel nView s1 system with insta-3D technology is a...
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 use within lumbar spine procedures. According to Surgalign, the HOLO Portal system is the world’s first...
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 function when compared to placebo. This is according to the latest data from the SUNFISH...
Nevro Corporation has announced the results from data presentations at the 25th North American Neuromodulation Society (NANS) annual meeting (13–15 January 2022; Orlando, USA) supporting the use of 10kHz spinal cord stimulation (SCS) therapy for patients with chronic pain. These...
Almost 90% of scoliosis patients who develop a major neurological deficit after corrective surgery either partially or completely recover within two years, a recent single-centre analysis suggests. The findings, published by Jue Li (Nanjing Drum Tower Hospital, Nanjing, China) et...
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 vertebral body augmentation system, VCFix. The financing round was co-led by the founders and existing venture...
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 a graphical representation of tools seen in intra-operative 2D images onto axial and sagittal views...
Whole spine magnetic resonance imaging (MRI) rather than cervical spine MRI should be used in children with suspected abusive head trauma in order to avoid missing isolated thoracolumbar injuries, according to a recent article published in the American Roentgen...
Wavegate Corporation has announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its StimuLux optical reflectometry system for closed-loop adaptive modulation of spinal cord stimulation.  Breakthrough device designation aims to expedite the development and...
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 which were recently released at the North American Neuromodulation Society’s (NANS) 25th annual meeting (13–15...
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 a dorsal root ganglion (DRG) neurostimulator in patients suffering from chronic lower back pain. The first...
Inspan LLC has announced that it has received US Food and Drug Administration (FDA) clearance for its interspinous plate fixation device to be used for spinal fusion and spinal stenosis from T1-S1. The Inspan Spinous Process Plate System is a...
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 Titanium Cervical Plate System. The Quantum system offers multiple features, including a nested assembly in which...
Maricela Schnur (St Luke’s Hospital, Duluth, USA) highlights a handful of socioeconomic disparities, racial differences, and psychological and psychiatric factors that currently present difficulties in patient access to spinal cord stimulation (SCS). Barriers and gaps in the delivery of healthcare...
There is no clear benefit associated with artificial disc replacement (ADR) compared with fusion surgery when it comes to patient satisfaction, sustainability, and protection against adjacent-segment pathology (ASP) in those who have received anterior decompression due to cervical degenerative...
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 committee. West currently serves as the president, chief executive officer and director of Intersect ENT, a...
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 various screw and hook options, multiple transition rods and, according to the company, revolutionary crosslink...
A whole host of research, on topics ranging from sciatica surgery and spinal cord stimulation to vertebral augmentation and laminectomy plus instrumented fusion, dominated our December’s most read stories. Also popular last month were recent industry announcements from Philips,...
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 thoracolumbar interbody portfolio for spine surgery. Attrax Putty is a synthetic, bioactive and osteoconductive bone void filler...
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 stimulation (SCS) system with Octrode leads. The new labelling lifts MRI restrictions for lead tip location and...
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 is according to a new meta-analysis published recently in the journal Spine by Robert Chang...
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 (IS). The study—the findings of which were published in the journal Spine by Charles Peeters (University...
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 spine surgeon, Vresilovic most recently practiced with UPMC Orthopaedic Specialists of Central Pennsylvania (Lancaster, USA). He...
Surgical treatment for degenerative cervical myelopathy (DCM) leads to a satisfactory improvement of functional outcome which is maintained out to 10 years, a recent study has found. Published in the Journal of Neurosurgery: Spine by Mark Dijkman (Radboud University...
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 its ARC Therapy to restore hand and arm function in people with spinal cord injury...
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 with degenerative cervical myelopathy (DCM), according to a recent national study from Sweden. The findings, which...
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 arthroplasty (TDA) in relation to operative time, postoperative length of stay, rate of complications or...
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 company during a time of unprecedented growth and expansion,” said Tim Corvino, CEO of Spire....
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 management, radiofrequency ablation, or chemotherapy alone. These are the key findings from a meta-analysis published...
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 to a recent study published in the Journal of Neurosurgery: Spine by Hyung Rae Lee...
The effect on leg pain is the most important factor for patients when it comes to deciding whether or not to undergo surgery for sciatica. This is according to a recent study, which was published in the Journal of...
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, business and medical device innovation experience to Premia Spine, the new appointees will look to...
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 undergo expedited surgery, new research has indicated.   The results from a secondary analysis of a...
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 and a feature on the use of spinal cord stimulation to treat chronic pain are...
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, according to latest data from the TRIUMPH study. This prospective, international, multicentre, single-arm, post-market study—the 24-month...
Spine Wave has announced the launch of both the Defender anterior cervical plate and the Stronghold C 3D titanium interbody device featuring TiCell 3D advanced surface technology. The Defender anterior cervical plate is a titanium plate and screw system that...
Philips has announced that the first patients have been successfully treated using its 3D augmented reality (AR) spine navigation solution, ClarifEye, at Sant Joan de Déu Barcelona Children's Hospital (Barcelona, Spain) and the Armed Forces Hospital (Muscat, Oman). In both...
Low educational attainment and low income status are clear independent contributors to poorer outcomes following lumbar spine surgery, a new study, published in The Spine Journal by Emma Karran (University of South Australia, Adelaide, Australia) et al, has found. The...
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 modular cobalt chrome tulip heads that CoreLink say are designed to allow for intraoperative flexibility...
The use of spinal manipulative therapy (SMT) as initial treatment of chronic low back pain (cLBP) in older patients is associated with a substantial reduction in the long-term risk of adverse drug events (ADEs) when compared to those who...
Older age, male sex, benign prostatic hyperplasia, diabetes mellitus and a history of urinary tract infection are all risk factors for postoperative urinary retention (POUR) following elective spine surgery, according to a recent meta-analysis. The meta-analysis, the findings of which...
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 allows surgeons to easily learn and perform a wider range of lumbar spine procedures than...
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 consistent anterior cervical discectomy and fusion (ACDF) experience for spine surgeons. Don Park, vice chair of...
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 used for the first time in clinical practice at Helsinki University Hospital (Helsinki, Finland). Mika Niemelä,...
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 president, power tools, at DePuy Synthes, said: “The UNIUM system significantly enhances our power tools...
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 injuries   The investment, from venture capital firm Two Bear Capital, will be used to develop...
Patients who are either persistent opioid users, or are at risk of developing persistent opioid use, should be identified and offered counselling and support in order to taper off opioid treatment following degenerative lumbar surgery. This is according to...
High or low blood pressure in patients undergoing surgery to repair a spinal cord injury may contribute to poorer outcomes and maintaining an optimal blood pressure range during surgery may help patients recover motor function. These are the key...
Neuroplast has raised a total of €10 million in a Series B funding round, the money of which will be used to obtain conditional European Medicines Agency (EMA) market approval for its Neuro-Cells stem cell therapy to treat patients...
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 indicated for transforaminal lumbar interbody spinal fusion to treat degenerative disc disease, spondylolisthesis, or retrolisthesis. Under...
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 superiority” in terms of proximal facet joint protection in transforaminal lumbar interbody fusion (TLIF) patients,...
Robotic guidance (RG) is associated with a lower risk of both surgical complications and revision surgery when compared with fluoroscopic guidance (FG) in adult minimally invasive (MIS) lumbar fusions, a new study has found. The prospective, multicentre study, MIS ReFRESH,...
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 the BAGUERA® C cervical disc prosthesis. In addition, the company has also reached an exclusive...
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 Medical Association (AMA) has accepted the addition of a new add-on Category I Current Procedural...
 Carlton Weatherby (Memphis, USA), vice president and general manager of spine and biologics at Medtronic, talks to Spinal News International about his own early experiences within a healthcare setting and specifically his “early affinity” to the field of spine. Spine...
Elderly patients undergoing minimally invasive (MIS) transforaminal lumbar interbody fusion (TLIF) not only had similar perioperative outcomes compared to younger patients, but also achieved comparable improvements in pain, disability and quality of life that were sustained for up to...
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 research aimed at understanding the root cause of disc degeneration and chronic back pain in...
Spinal Elements has announced that the first clinical cases using the Lucent 3D lumbar interbody system have been successfully completed. The first cases were undertaken by Thomas Noh, a neurosurgeon at Hawaii Pacific Health (Honololu, USA) and Douglas Musser...
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 suffering from traumatic spinal cord injury (TSCI), with data demonstrating that its investigational stem cell...
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 an interbody spinal fusion implant, with a focus on completing final regulatory testing and obtaining...
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 spine surgeries (ACSS). This was the main finding of a recent study, presented at the...
Minimally invasive spine surgery results in a significantly lower incidence of dural tear and complications when compared to open surgery in patients with degenerative lumbar pathologies, new research suggests. The study—the findings of which were presented by Ayush Sharma (Dr....
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 and updated as a result. These were the key messages to come out of a presentation by...
Medtronic has announced its ambition to achieve net zero carbon emissions by fiscal year 2045 across its operations and value chain to accelerate efforts to combat climate change. The announcement comes amidst the 2021 United Nations Climate Change Conference...
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 John Chi (Boston, USA), support the use of Premier Spine’s Tops system for lumbar spinal...
Brian Goh (Boston, USA) speaks to Spinal News International about the results of a study that aimed to better understand the impact of surgical intervention in patients who sustained gunshot wound induced spinal injuries (GSIs), the results of which...
Following the recent approval of the Senza system (Nevro) by the US Food and Drug Administration (FDA), Erika A Petersen (Little Rock, USA) discusses the impact of the only spinal cord stimulation (SCS) device indicated to treat chronic pain associated...
Erector spinae plane block (ESPB) is effective in decreasing both postoperative pain intensity and postoperative opioid consumption after spine surgery, according to findings from a recent systematic review and meta-analysis which were published in the European Spine Journal by...
Early surgical decompression after foot drop is beneficial in terms of recovery rate and neurological improvement when compared with late surgery. This is according to a new meta-analysis which also indicates that surgery within one month is recommended for...
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 for PDN which, according to NeoSpine, is the only SCS system approved by the US...
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 pedicle screw fixation. Mariner MIS Wayfinder eliminates reliance on traditional guidewires for percutaneous screw placement by...
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— for cash and common stock. According to the terms of the merger agreement, Misonix has become...
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 to 12 months, a new prospective multicentre study has found. The study, the findings of which...
Nuvasive has announced the release of a virtual reality (VR) training module for the NuVasive X360 system to complement its Clinical Professional Development (CPD) programme. In collaboration with PrecisionOS, developers of a medical-grade VR learning platform, the NuVasive X360 VR...
For spinal muscular atrophy (SMA) patients with complex spine anatomy, the subcutaneous intrathecal catheter (SIC) allows for reliable outpatient administration of nusinersen that results in meaningful improvements in upper limb function, but introduces risks of technical malfunction and iatrogenic...
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 procedural solution for surgical planning, workflow, execution and confirmation, and is, according to the company,...
Anterior vertebral body tethering (AVBT) of skeletally immature patients is associated with satisfactory deformity correction in the majority of cases, new research has found. However, complication and revision rates suggest the need for improved implants and patient selection. In addition,...
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 as part of the quarterly update of the 2021 Medicare Hospital Outpatient Prospective Payment System. The...
The choice of lumbar interbody fusion approach influences adjacent segment motion in a cadaveric model, according to new research published in the journal Spine, the findings of which also showed that lateral lumbar interbody fusion had the least adjacent...
 Everard Munting (Ottignies-Louvain-la-Neuve, Belgium), the current president of Eurospine, talks to Spinal News International about this year’s annual meeting, which took place between the 6–8 October in Vienna, Austria. Munting notes that “everybody was extremely happy to be there...
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. These two additions mean that it is the only company to offer both porous PEEK...
Artificial intelligence (AI) has the capability to accurately and reliably detect thoracolumbar fractures on sagittal radiographs, according the findings from a retrospective study that was presented during a Best of Show session at the 2021 Eurospine annual meeting (6–8...
Transforaminal epidural steroid injection (TFESI) should be considered as a first invasive treatment option, up to 12 months, for patients with sciatica secondary to herniated lumbar disc. This is according to the results of a randomised controlled trial, NERVES,...
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 spinal deformity (ASD) is associated with durable outcomes that do not deteriorate over time and...
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 to support micro invasive procedures ranging from endoscopic transforaminal lumbar interbody fusion to transforaminal and...
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 Mittleman, ReVivo Medical president and CEO, said: “Raising funds is never an easy task and...
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 in Brazil. The obtention of ANVISA clearance was the last step in the registration process of SpineGuard’s DSG...
Amber Implants has announced that its VCFix spinal system, which aims to improve the treatment of vertebral fractures, has been granted breakthrough device designation by the US Food and Drug Administration (FDA). The FDA breakthrough device program aims to provide...
Michael Kachmann and Zachary Tempel from Mayfield Brain & Spine (Norwood, USA) and Paul Holman from Houston Methodist Hospital (Houston, USA) have successfully completed the first commercial cases with NuVasive’s Pulse platform.  Kachmann and Tempel performed the first commercial case...
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 assess its true efficacy, new research has shown.   However, although she systematic review, published by Tommy Nguyen...
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 and provides the strength and biocompatibility of titanium and a modulus of elasticity comparable to...
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 carries an increased risk of infection-related events, a new retrospective study has found.   The objective of...
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 large, anatomy-conforming implant via anatomy-conserving lateral decubitus and prone approaches. The porous titanium blocks are made...
Joimax has announced the global launch of its NAVENTO navigation endoscopic tower, which can be used for endoscopic spine surgery and includes settings that are designed to for the safe treatment of sensitive structures. The fourth generation endo-tower, which will...
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 a titanium plate polyetheretherketone (PEEK) cage with cortical cancellous screws which are intended to provide...
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 on the heels of Camber’s announcement last month that it has received US Food and...
Patients undergoing revision posterior cervical discectomy and fusion (PCDF) procedures had a decreased risk of required intensive care unit (ICU) stay but greater risk of 30-day emergency department (ED) admission and higher direct hospitalisation and surgical costs than those undertaking...
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 recent study published in the journal Spine. The multicentre observational study authored by Siril Holmberg (Norwegian University of Science and Technology,...
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 International about his own experience with the titanium cervical BEE® cage (NGMedical), how the spinal implant optimises bone ingrowth...
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 Pedicle Screw Technology, which allows the surgeon to lock the polyaxial angle of the pedicle...
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 body fusion procedures for various diseases of the lumbar spine, such as degenerative disc disease—in...
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 used in skeletally mature patients in levels C2-T1 in conjunction with fixation for ACDF (anterior...
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 have been integrated into Spinal Elements as the newest technologies in its MIS Ultra platform of...
Centinel Spine has announced the first international implantation of the 3D-printed porous titanium FLX platform. Alfredo Guiroy and Jose Ricardo Prina in Argentina were the first surgeons outside the USA to implant the Stalif C FLX and Stalif M...
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 to new data.   The purpose of this prospective, non-randomised, historically controlled, multicentre US Food and Drug Administration (FDA)...
There is an increased prevalence of depression in patients with degenerative spine disease (DSD) and, considering the relationship between depression and poor surgical outcomes, more attention should be paid to identifying strategies for preventing and treating depression in DSD...
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 sustained pain relief within minutes—for its WaveWriter Alpha Spinal Cord Stimulator (SCS) systems. While traditional paraesthesia-free...
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 progress, a new study has suggested.   Published in The Spine Journal, by Neda Gilmartin and Jeffrey Gum (Norton...
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 can be used in both posterior lumbar interbody fusion and transforaminal lumbar interbody fusion procedures. It features the lowest insertion...
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 system for the lumbar spine. The study is one of the largest total disc replacement patient...
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 Calafiore has been appointed chief commercial officer, and Ryan Donahoe has been appointed chief technology...
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 Pedicle Screw System is designed to provide immobilisation and stabilisation of spinal segments in skeletally...
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 help it to expand applications of its UnifiMI technology. The investment in OsteoCentric Technologies—founded in 2015...
Intraoperative freehand erector spinae plane block (ESPB) as part of multimodal analgaesia is effective and, for posterior instrumented patients with spondylolisthesis, it can relieve postoperative backache and reduce opioid consumption. This is according to new data published in the...
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 published by Tonje Johansen (St Olavs Hospital, Trondheim, Norway) et al in the Journal of the American Medical Association (JAMA) indicated that there were similar...
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 in the Journal of Neurosurgery: Spine. Blake Hauser (Harvard Medical School, Boston, USA) et al...
Auctus Surgical has received US Food and Drug Administration (FDA) breakthrough device designation for its vertebral body tethering (VBT) system, which the company says treats paediatric scoliosis with a “non-fusion, dynamic approach”. This FDA designation allows for priority review and...
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 hospital electronic medical records (EMRs). It is designed to assist with sponge management, a leading...
Cerapedics has announced the publication of the results of a study to evaluate the cost-effectiveness of i-FACTOR peptide enhanced bone graft compared to autograft for patients undergoing anterior cervical discectomy and fusion (ACDF) surgery in ClinicoEconomics and Outcomes Research....
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 new research published in the New England Journal of Medicine (NEJM). An open-label, multicentre, non-inferiority randomised controlled...
As the effects of the COVID-19 pandemic continue, Daniel Sciubba (New York, USA), discusses how the ‘new normal’ of virtual communication has transformed medical practice and, in particular, how livestreaming technology can help educate and inform the next generation...
A large, high-quality, multicentre randomised controlled trial (RCT) is needed to determine the optimal surgical intervention for thoracolumbar burst fractures, according to new research. The systematic review and meta-analysis, published by Hannah Hughes (Mater Misericordiae University Hospital, Dublin, Ireland) et...
Bioventus has announced that it has entered into a definitive agreement to acquire Misonix—a provider of minimally invasive therapeutic ultrasonic technologies and regenerative medicine. The acquisition is expected to boost Misonix’s BoneScalpel and Nexus adoption through Bioventus’ spine surgical solutions...
Surgery for degenerative cervical myelopathy (DCM) is associated with significant and clinically-relevant improvements across a wide range of patient-reported outcomes at one year, a new study has found.   The findings of this Norwegian nationwide registry-based observational study—which were published by Sasha Gulati (St Olavs University Hospital, Trondheim,...
Camber Spine has received US Food and Drug Administration (FDA) 510(k) clearance for both its SPIRA-P posterior lumbar spacer technology and SPIRA-T oblique posterior lumbar spacer technology. Part of the SPIRA product platform, the SPIRA-P posterior lumbar spacer can be...
Orthofix has announced the first patient implant in a US Food and Drug Administration (FDA) investigational device exemption (IDE) study that will evaluate the safety and effectiveness of the M6-C artificial cervical disc compared to anterior cervical discectomy and...
IZI Medical has officially launched Vertefix HV Cement, a product which aims to address the need for real-time flow visualisation during cement injection for vertebroplasty and kyphoplasty procedures.  Greg Groenke, CEO of IZI Medical, said: “Our goal in developing Vertefix...
NuVasive has announced that it has received US Food and Drug Administration 510(k) clearance for its Pulse platform, after receiving CE mark certification earlier this summer. In addition, the company has announced the commercial launch of Pulse which is...
Symptomatic Type 1 spinal muscular atrophy (SMA) infants treated with Evrysdi (risdiplam) showed significant improvements in survival, motor milestones, and motor function compared to historical controls, according to findings from the FIREFISH Part 2 study, which have been published...
MiRus has raised US$65 million in a new funding round that will help the firm grow its spinal and extremity portfolios and development of structural heart disease solutions using its proprietary Rhenium-based alloys (MoRe).  The round was led by Mammoth...
Aesculap Implant Systems has announced the publication of seven-year results from a randomised controlled investigational device exemption (IDE) trial for lumbar artificial discs in single-level degenerative disc disease (DDD), which indicated that the activL artificial disc demonstrates prolonged significant...
NuVasive has announced the commercial launch of Modulus ALIF, a 3D-printed porous titanium implant for anterior lumbar interbody fusion (ALIF), in targeted global regions. “Modulus ALIF has been one of NuVasive's most successful clinical evaluations to date with continued surgeon...
Nevro has announced receipt of US Food and Drug Administration (FDA) approval for its Senza system to treat chronic pain associated with painful diabetic neuropathy (PDN). This approval is specific to the company’s 10kHz stimulation—making it the only FDA-approved...
Activity-based rehabilitation interventions, including transcranial magnetic stimulation, functional electrical stimulation, and robotic-assisted treadmill training are effective in improving function in patients with spinal cord injury, according to a new systematic review and meta-analysis. The study—the findings of which were published...
Researchers at Indiana University School of Medicine (Indianapolis, USA) have announced the successful reprogramming of a glial cell type in the central nervous system into new neurons in order to promote recovery after spinal cord injury—revealing an ‘untapped potential’...
Biotechnology outfit Lineage Cell Therapeutics has announced that it will return to clinical testing with its investigational allogeneic oligodendrocyte progenitor cell (OPC) transplant therapy for the treatment of spinal cord injury (SCI). Following feedback from the US Food and Drug...
A collaborative effort between the University of Louisville and Medtronic to apply epidural stimulation therapy to those with spinal cord injury has been given a boost thanks to a US$7.8 million grant from the National Institute of Neurological Disorders...
A high body mass index (BMI) has no significant bearing on functional and clinical outcomes for patients treated by minimally invasive transforaminal lumbar interbody fusion (MI-TLIF), according to a new study published in the European Spine Journal. The retrospective study...
SeaSpine has announced that it has received FDA 510(k) clearance of its 7D Percutaneous Spine Module for minimally invasive surgery (MIS). This represents a new application and increased functionality for its 7D Flash Navigation System, says SeaSpine, and follows the...
ReVivo Medical has announced that two spinal and orthopaedic experts are joining its Board of Advisors as the company get ready to recruit for a new clinical study. Hassan Serhan, former distinguished engineering fellow, senior director, research and technology, at...
ZygoFix has obtained CE mark for its minimally invasive screwless spinal fusion system, called zLOCK, for the treatment of chronic back pain. ZygoFix completed the certification process and received CE mark for its zLOCK spinal fusion system for lumbar spine after...
NuVasive has revealed that its Pulse platform received CE Mark approval for its latest design update and clinical evaluations are now underway in multiple countries throughout Europe. Pulse is designed to act as one platform to assist surgeons in all...
A team of engineers and clinicians at the University of Cambridge (Cambridge, UK) have developed an ultra-thin, inflatable spinal device that can be used to treat the most severe forms of pain without the need for invasive surgery. The device,...
joimax has announced the global launch of its new generation of Shrill Shaver Drill System — a device which is used to remove soft tissue and bone on the spine. This latest iteration has been retooled to provide better user...
Those with back and neck problems can now download a free 20-page patient guide that outlines in detail when a person should consider artificial disc replacement. The guide, called ‘Back in Motion’ and which can be found at CentersforArtificialDisc.com, was...
This advertorial is sponsored by Spine Innovations The ability to restore spinal function is an important consideration when choosing options for the replacement of degenerated discs in the cervical or lumbar spine—in particular when there is an alternative to spinal...
A single-level titanium interspinous device is associated with inferior patient outcomes when compared to laminectomy alone, a new retrospective study published in the journal Spine has shown.  The study, which was led by Aaron J. Buckland (NYU Langone Health, New York, USA and Melbourne Orthopaedic Group,...
PTC Therapeutics has announced that Evrysdi (risdiplam) has been approved in Japan by the Japanese Ministry of Health, Labor and Welfare for the treatment of spinal muscular atrophy (SMA). The approval has been granted based on data from two pivotal studies, FIREFISH and...
The potential benefits of a novel bioresorbable polymer scaffold in patients with complete thoracic spinal cord injury outweigh the risks, but further clinical investigation as part of a randomised controlled trial is needed, according to the authors of the INSPIRE study,...
CoreLink has announced the commercial launch and 510(k) clearance from the US Food and Drug Administration (FDA) for its F3D Corpectomy Vertebral Body Replacement (VBR) System. The CoreLink F3D Corpectomy VBR System features a single-piece construct to replace damaged vertebral bodies...
Spino Modulation, a subsidiary of Spinologics, has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for its MIScoli system, a vertebral body tethering (VBT) device used to treat scoliosis in young adolescents. The MIScoli system...
ONWARD has announced the that it has received breakthrough device designation status from the US Food and Drug Administration (FDA) for their ARC-IM platform for blood pressure and trunk control in people with spinal cord injury. This is the third...
Ultrasonic bone scalpel (USBS) does not reduce blood loss during posterior spinal fusion (PSF) in patients with adolescent idiopathic scoliosis (AIS), a randomised controlled trial published in the journal Spine has found. The study, which was published by Sumeet Garg (Children's...
The severity of thoracic intervertebral disc (IVD) degeneration and the number of degenerated levels increase with age, according to a new study published in the European Spine Journal. The findings, published by Mohamed Kamal Mesregah (Keck School of Medicine of...
Neo Medical has received US Food and Drug Administration (FDA) 510(k) clearance for the use of its Pedicle Screw System in late stage tumour indications, in combination with BonOs Inject cement from OSARTIS. The company also obtained CE certification...
The widely prescribed pain-relief drug gabapentin can prevent harmful structural changes in the injured spinal cords of mice, and also block cardiovascular changes and immune suppression caused by spinal cord injury, research led by the Ohio State University Wexner...
AO Foundation has announced the launch of a variety of spine-specific protocols as part of its large-scale novel multinational registry, AO Global Data. AO Spine members now have the opportunity to participate in AO Global Data. AO Spine Knowledge Forums endorsed...
Two thirds of all paediatric spinal fractures that occur in the US are related to people not wearing seatbelts, according to a recent study in the journal Spine. Research by Vishal Sarwahi (Cohen Children's Medical Center, New York, USA) et...
Medtronic has received US Food and Drug Administration (FDA) approval for its Vanta device—a recharge-free implantable neurostimulator (INS) with a device life that Medtronic say last up to 11 years.   A company press release states that, at comparable settings,...
Empirical Spine has announced the closing of a US$10 million Series B financing round, the funds of which will be used to advance its LimiFlex Paraspinous Tension Band on its path to market in the USA.   This includes completing...
Spectrum Spine has acquired what it describes as a highly unique and proprietary surface technology for spinal trauma, called BIOBraille, and has begun operations with the device. BIOBraille is a state-of-the-art surface technology with 14 related patents, exclusively licensed to...
Medtronic has announced that it has received US Food and Drug Administration (FDA) clearance of patient-specific UNiD Rods for use with its CD Horizon Solera Voyager and Infinity occipitocervical upper thoracic (OCT) spinal systems. According to Medtronic, UNiD Rods are...
Frank Phillips (Chicago, USA) reflects on his experience as president of the International Society for the Advancement of Spine Surgery (ISASS), which held its annual in-person meeting 13–15 May 2021 in Miami, USA. Phillips gives Spinal News International an insight...
Orthofix Medical has announced that it will continue its sponsorship of Olympic gold medalist and spine patient Laura Wilkinson as she undertakes her quest to reach the Tokyo Olympics. Wilkinson, a three-time US Olympic platform diver, is competing for a...
United Spinal Association has acquired online platform, AbleThrive, in a move designed to ensure people with spinal cord injuries and disorders (SCI/D) have greater access to resources and support. Over the coming months, United Spinal and AbleThrive will combine their...
Spinal Stabilization Technologies (SST) has announced that it has earned the CE Mark and the FDA's breakthrough designation for its PerQdisc™ Nucleus Replacement System for degenerative disc disease (DDD). The PerQdisc device replaces the nucleus pulposus of the intervertebral disc...
ChoiceSpine has announced that it has received clearance from the US Food and Drug Administration (FDA) to market the Blackhawk Ti cervical spacer system. According to ChoiceSpine, Blackhawk Ti is the first to market 3D-printed system that utilises preassembled integrated...
The European Union (EU) Medical Devices Regulation (MDR) has taken effect from 26 May 2021. The Regulation revises quality and safety standards and the range of regulated devices. It was first initiated in May 2017, with an initial three-year transition...
South Korean medical robotics company CUREXO has announced that its spinal surgery robot, CUVIS-spine, has now acquired US Food and Drug Administration (FDA) licensing. This is the third license acquired for CUVIS-spine as the company looks to expand its global...
The WaveWriter Alpha Spinal Cord Stimulator (SCS) System (Boston Scientific) has been named Best Overall Medical Device Solution at the fifth annual MedTech Breakthrough Awards. Launched earlier this year, the WaveWriter Alpha SCS System is a unified portfolio of four...
Vertos Medical has released the results of an independent, retrospective cohort study which found that 88% of lumbar spinal stenosis (LSS) patients avoided surgical lumbar decompression for at least five years after receiving the minimally invasive lumbar decompression (mild®) procedure. The...
The diagnosis of cannabis use disorder for patients undergoing spinal surgery is associated with higher complication rates, including substantially increased risks of stroke and respiratory complications, according to a recent study published in the Spine journal.   The new research, which was conducted by Ankit Indravadan Mehta and colleagues from the University of Illinois (Chicago, USA), was designed...
Orthofix Medical has announced preliminary three- and four-year functional outcomes from the M6-C artificial cervical disc single-level investigational device exemption (IDE) study which has shown that the device continues to have statistically significant benefits as compared to anterior cervical discectomy and fusion...
Stratus Medical and the University of Kansas Medical Center have announced that the first patient has been enrolled in the EMERALD study–a level I, prospective, randomised control trial, comparing the Nimbus radiofrequency (RF) multitined expandable electrode to conservative care for...
Spine surgeons at UC San Diego Health (San Diego, USA) have begun using augmented reality (AR) headsets that give them 'X-ray vision' during procedures for accurate and personalised implant placement, while allowing them to keep their eyes on their...
The American Association of Neurological Surgeons (AANS) and the American Academy of Orthopaedic Surgeons (AAOS) have announced that Medtronic has become the latest industry sponsor of the American Spine Registry (ASR). A collaboration between the AANS and AAOS, the ASR...
Life Spine has announced the completion of the first surgeries with the TRULIFT Expandable Spacer System–a micro-invasive technology for use in transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) procedures. According to Life Spine, the TRULIFT Expandable...
4WEB Medical has announced the initial launch of its Lumbar Spine Plating Solution (LSTS-PS), with the first procedures performed by James Lynch, neurosurgeon and CEO of Spine Nevada at Renown Medical Center (Reno, USA). Lynch said: “By adding a lumbar...
The use of metal-on-metal (MoM) artificial discs in two-level anterior cervical disc replacement (ACDR) results in superior patient-reported clinical outcome scores compared to metal-on-plastic (MoP) artificial discs, a meta-analysis recently published in The Spine Journal by Daniel Coban (St Joseph's University Medical Center, Paterson, USA) et al has found. However, the meta-analysis...
Medtronic has announced the launch of CareGuidePro, a new mobile application and web portal that serves as a virtual guide for patients throughout their spinal cord stimulation therapy journey. The patient's care team, including physicians and Medtronic, may also use...
EDGe Surgical has been granted a US patent for its next-generation Awl-in-One Tap device–a single-use spinal surgery instrument with disposable neuromonitoring electromyography (EMG) system and digital depth measurement built in.   The device, which is under development and is designed...
Roger Härtl (New York, USA) discusses his research into traumatic spinal and spinal cord injuries in East African countries, looking specifically at which treatments are more economically beneficial. Injuries to the spine and spinal cord from trauma occur worldwide...
Cerapedics has announced that it has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for its investigational P-15L bone graft for the treatment of degenerative disc disease (DDD). The FDA’s Breakthrough Device designation is designed...
Orthofix Medical has announced the US Food and Drug Administration (FDA) has given 510(k) clearance for its 3D-printed Construx mini titanium spacer system. In a company press release, it was also announced that the first patient had been implanted...
TheraCell has announced the completion of the first two spinal surgeries using its novel TheraFuze DBF Fiber Bag—an allograft alternative to the resorbable polymer mesh bag products that are currently on the market. The first of these cases was a...
NuVasive has gained FDA approval for its Simplify Cervical Artificial Disc, allowing the device to be used in two-level cervical total disc replacement (cTDR) procedures. According to the US medical device company, the Simplify Disc demonstrated clinical superiority at 24...
Medtronic has announced that the US Food and Drug Administration (FDA) has approved the revised commercial labelling for the Intellis platform with differential target multiplexed (DTM) programming. This is to reflect the outcomes of a randomised controlled trial which,...
Alphatec Holdings has announced the launch of the InVictus occipital-cervical-thoracic (OCT) spinal fixation system, which extends the sophistication of the InVictus posterior fixation platform to the entire spine. A company press release claims the InVictus system is engineered to...
4WEB Medical, an orthopaedic device company focused on developing innovative implants utilising its proprietary Truss Implant Technology, has announced that the company has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its lumbar plating...
A prospective clinical study published in Neurosurgery has found that lumbar fusions were three times more likely to be effective and obtain better patient outcomes when guidelines for fusion were followed. According to researchers, these results suggest that when surgeons...
Results of a trial published in the journal Pain Medicine reports that percutaneous peripheral nerve stimulation (PNS) show “clinically significant” reductions in pain, disability, and pain interface in patients with chronic lower back pain.  Authors, Timothy R Deer et al, note that lumbar...
7D Surgical, a Toronto-based medical device company developing optical and machine-vision technologies for surgical navigation, has announced that it has launched its FLASH navigation system in Germany and Switzerland, with multiple units already placed and over 30 spinal procedures...
Spine Wave has announced the commercial launch of its Stronghold 3D titanium interbody device featuring TiCell 3D advanced surface technology.  According to a company press release, the new titanium lumbar interbody fusion implant is manufactured using a direct metal laser...
NuVasive and the International Spine Study Group Foundation (ISSGF) have announced the continuation of their long-term partnership by launching two new clinical studies focused on improving patient outcomes in adult spinal deformity surgery.  "NuVasive is excited to extend our partnership...
ReVivo Medical has announced that in an effort to attract more investor funding in the future, it has changed its entity classification from a limited liability company to a Delaware corporation. Additionally, the company reports its intention for an...
Celéri Health has announced the first patient has been enrolled in the UPGRADE study which is a large registry of patients using DTM Spinal Cord Stimulation (SCS) available only on the Medtronic Intellis platform. According to a company press...
Empirical Spine, maker of the LimiFlex paraspinous tension band, has announced initiation of the PMA process for the US Food and Drug Administration (FDA) review and approval of the use of the LimiFlex with a decompression for patients suffering...
Aurora Spine has announced the launch of its proprietary SiLO posterior SI joint fusion system (SiLO), which was designed specifically for posterior sacroiliac joint fusion, according to a company press release.  Aurora Spine claims the SiLO posterior SI joint fusion...
NuVasive has acquired Simplify Medical, a privately-held company and developer of the Simplify Cervical Artificial Disc (Simplify Disc) for cervical total disc replacement (cTDR). According to a company press release, with this acquisition NuVasive is now able to address all...
Fusion Robotics has announced receiving 510(k) clearance from the US Food and Drug Administration (FDA) to market their 3D imaging-compatible navigation and robotic targeting system for spine surgery in the US market. Brad Clayton, CEO of Fusion Robotics, Louisville, USA,...
A new study to be published in Spine has found that deep learning applications are able to identify previous spinal implants. In some cases, Hee-Seok Yang et al report over 90% precision using deep learning.   The paper, entitled “Deep learning application in spinal...
ControlRad has announced US Food and Drug Administration (FDA) 510(k) clearance to market ControlRad Select, a technology that utilises proprietary semi-transparent filters, a user-interface tablet, and image processing algorithms to reduce radiation exposure during fluoroscopically-guided procedures. The technology is retrofitted...
MiRus has announced the launch of MoRe Promise, a lifetime limited warranty on its Molybdenum-Rhenium (MoRe) superalloy rod technology. In a company press release, MiRus states the warranty will cover full replacement of the MoRe Rod and corresponding MiRus...
AlloSource has announced that the first patients have been enrolled in a randomised controlled study to evaluate the effectiveness of AlloWrap amniotic membrane for the reduction of postoperative soft tissue inflammation in two-level anterior cervical discectomy and fusion (ACDF)...
SeaSpine has announced the full commercial launch of the Reef TO transforaminal lumbar interbody fusion (TLIF) oblique interbody system.  According to a company press release, the Reef TO interbody system is designed for posterior lumbar interbody procedures and accommodates both direct impact insertion and insert-and-rotate techniques. With a comprehensive set of decompression, disc...
Anuncia has announced that it has received US Food and Drug Administration (FDA) breakthrough device designation for its ReFlow system mini, intended for the treatment of cerebral spinal fluid (CSF) disorders requiring shunting.  Elsa Abruzzo, president of Anuncia, stated: "Our team is very pleased to achieve this...
ReWalk Robotics has announced it has entered into a contract with BKK Mobil Oil Insurance to provide ReWalk personal exoskeleton devices to its eligible beneficiaries with spinal cord injury (SCI) in Germany.  According to ReWalk, the contractual arrangement is the...
BrainStorm Cell Therapeutics announced it recently met with senior leadership from the US Food and Drug Administration (FDA) and received feedback on a high-level data summary from the NurOwn (autologous MSC-NTF cells) amyotrophic lateral sclerosis (ALS) phase III clinical trial.   According to a press release...
Medtronic has received approval from the US Food and Drug Administration (FDA) for expanded magnetic resonance imaging (MRI) InterStim II and InterStim Micro sacral neuromodulation (SNM) systems that use SureScan MRI leads.  Medtronic report that SNM uses a small device...
Study results presented at the 2021 annual meeting of the Orthopaedic Research Society (12–16 February, virtual) report that a radioactive bone cement could provide a safer alternative to conventional radiation therapy for bone tumours.  The study was conducted at the...

C2Dx acquires Stryker T/Pump

C2Dx Inc has announced their acquisition of the T/Pump product line from Stryker. According to a company press release, the T/Pump is the second product line for C2Dx, joining its initial acquisition of the STIC Intra-Compartmental pressure monitor.  C2Dx stated...
Medtronic has announced the first use of Midas Rex drills and navigated disc prep and interbodies with the Mazor robotic guidance system for minimally-invasive spine surgery in the US. According to a company press release, Gregory Poulter (Otholndy, Indianapolis, USA),...
A new position paper published in the journal Osteoporosis International by the International Osteoporosis Foundation (IOF) fracture working group, which urges for the routine use of vertebral fracture assessment (VFA) within post-fracture care coordination programmes such as fracture liaison...
Royal Philips has introduced ClarifEye augmented reality (AR) surgical navigation, a solution to advance minimally-invasive spine procedures in the hybrid operating room. Philips claims in a company press release that by combining superb 2D and 3D visualisations at low X-ray...
Zavation Medical Products has announced the launch of Labyrinth, a porous PEEK interbody cage. This is the latest addition to Zavation’s portfolio, which the company reports features the first available porous endplates integrated through the full cage. According to Zavation,...
NGMedical has announced that its titanium cervical Bee cage has received clearance from the US Food and Drug Administration (FDA). According to the company the Bee cage is designed to challenge the limits of additive manufacturing.  NGMedical claim in a...
TheraCell has announced the first surgical case using its TheraFuze DBF Fiber Wrap. According to TheraCell, this is the third new product in the company's portfolio of procedure-specific fiber graft solutions to be implanted in  the past few weeks. A...
icotec ag has announced the US market release of its BlackArmor carbon/PEEK implants. According to a company press release, it is the world’s first 100% non-metallic (plate and screws) anterior cervical plate system. The announcement comes after the device...
Spinal Elements has announced that it has received clearance from the US Food and Drug Administration (FDA) for its Lucent XP-Curved expandable interbody device. Lucent XP-Curved is the third platform in the Lucent XP family of expandable devices and...
Inspired Spine has announced that its Trident SI Joint Screw System, for use in the sacroiliac (SI) joint, has received 510(k) clearance from the US Food and Drug Administration (FDA). The product is manufactured by Advanced Research Medical (ARM).  According...
Camber Spine has announced that it has received a notice of allowance from the US Patent and Trademark Office (USPTO) for its Spira Lateral 3.0 interbody fusion implant. Camber Spine state that as part of the Spira product platform, the...
SeaSpine has announced the limited commercial launch of its Regatta lateral plate system. This is its first standalone lateral plate. According to the company, this lateral lumbar interbody fusion (LLIF) fixation system allows for multiple plating options, including one, two,...
Chirag A Berry (Cincinnati, USA) is an assistant professor at the University of Cincinnati College of Medicine. Here he provides a summary of his recent publication in The Spine Journal, entitled, ‘Inclusion of L5−S1 in oblique lumbar interbody fusion−techniques...
Findings of a randomised, prospective study suggest that non-surgical refractory back pain (NSRBP) patients have better outcomes with 10KhZ spinal cord stimulation (SCS) and conventional medical management (CMM), than CMM alone. The study findings were presented as a late-breaking...
Abbott has announced the launch of its NeuroSphere myPath digital health app, designed to track and report patient perceived pain relief and general well-being associated with spinal cord stimulation (SCS) or dorsal root ganglion (DRG) therapy. These reports are...
N2 Biomedical has announced that the first polyetheretherketone (PEEK) interbody fusion device coated with its titanium coating technology was successfully implanted in a patient. This coating forms part of the company's NanoTitanium family of coatings.  According to N2 Biomedical, the...
Boston Scientific has announced that its WaveWriter Alpha spinal cord stimulation (SCS) systems will have a limited market release in the USA. The SCS portfolio is intended for personalised pain relief.  According to a company press release, the unified portfolio...
ONWARD has announced that the first patient has been enrolled in a pivotal trial evaluating its ARC Therapy, according to a company press release. The trial, named Up-LIFT, will evaluate the safety and effectiveness of ARC Therapy in restoring...
TheraCell has announced the first surgical use of TheraFuze DBF Fiber Bullets. According to a press release from the company, the DBF Fiber Form is designed for minimal access delivery into expandable cages, revisions and other surgical applications. TheraCell reports...
NuVasive has announced that a new study published in The Spine Journal could validate single-position spine surgery as having significant advantages over traditional, open spinal fusion. The study entitled "Single position circumferential fusion improves operative efficiency, reduces complications and length...
Stryker announced the launch of T7, its personal protection system. According to their press release, the T7 and T7plus create a personal protection system that is tailored to each user, keeping them cool and comfortable without sacrificing protection during...
Endo International announced in a press release that its subsidiary Endo Ventures has entered into definitive agreements with Radius Health to register, commercialise and distribute abaloparatide on an exclusive basis in Canada. According to the company, abaloparatide is a parathyroid...
Saluda medical has announced today that the UK’s National Institute for Health and Care Excellence (NICE) issued a Medtech Innovation Briefing (MIB) on Saluda’s Evoke closed-loop spinal cord stimulation (SCS) system.  The briefing is entitled, “Evoke spinal cord stimulator for...
A new study, published in the journal Neuromodulation, has found that patients show a preference for a one-stage spinal cord stimulation (SCS) screening trial, both before and after implantation. This was regardless of whether patients had undergone a one-stage...
Centinel Spine has announced the first implantation of newly available angled endplates in the USA for the prodisc L Lumbar Total Disc Replacement System. According to their press release these endplates have been designed to shift the lordotic angle...
A press release by the Hospital for Special Surgery (HSS), claims that the microscopic structure of bone appears to predict which patients will experience poor outcomes after spinal fusion, according to a new study published in Bone. The press release...
Medtronic has announced that the US Food and Drug Administration (FDA), has given clearance for the use of its navigated interbody and Midas Rex high speed drills with the Mazor Robotic Guidance System. According to Medtronic, this has come...
G-21 and icotec ag have announced strategic corporation to use G-21’s bone cement in conjunction with icotec’s VADER pedicle screw system in the USA.  According to icotec’s press release, the VADER pedicle system is intended to restore the integrity of...
The Centers for Medicare and Medicaid Services (CMS) have announced that Stryker’s SpineJack System has qualified for the Transitional pass-through (TPT) payment. The TPT payment will become effective from January 2021, and forms part of the 2021 Medicare hospital...
Nexxt Spine has announced the first implantation of its NEXXT MATRIXX SA Cervical Turn-Lock system. The system is based around an intentionally engineered 3D laser printed titanium implant with varying pore sizes including 300μ, 500μ, and 700μ. Each printed interbody...
Transparency Market Research has estimated that the motion preservation devices market is estimated to grow in value to US$1501.9 million by 2027.  The company reports a reason for this estimation is an aging population with an increasing number of people...
Centinel Spine, a privately-held spine company focused on anterior column reconstruction, has announced its novel FLX technology platform of 3D-printed porous titanium interbody devices.  The FLX technology only became commercially available last year. These implants have been designed to mimic...
Integrity Implants, has today announced the publication of recent clinical articles in the International Journal of Spine Surgery (IJSS) which highlight the safety and efficacy of the FlareHawk expandable interbody cage.  According to a press release from Integrity Implants, the...
NuVasive has announced the launch of its C360 cervical spine portfolio, which includes the commercial launch of its Anterior Cervical Plating (ACP) system. The ACP system features the thinnest plate on market at 1.6 mm, according to a press...
A new study, published in the journal Spine Surgery and Related Research, is the first to visually capture the structure of biofilm on retrieved implants from patients who underwent spine surgery for pseudarthrosis. Previous studies in this area are...
Boston Scientific has launched their Wavewriter Alpha spinal cord stimulator (SMS) systems, to the European market, after receiving their CE mark. This product is intended to be used for the management of chronic intractable pain. The Wavewriter Alpha works by...
In a new study published in European Spine Journal, Ahmad M. Tarawneh, Nottingham University Hospital, Nottingham, England, creates a systematic review aimed at analysing the incidence of complications and unplanned reoperations after surgery for metastatic spinal tumours. Patients with...
The Stentrode brain-computer interface (BCI) has successfully been demonstrated by researchers to help patients with severe paralyses compete tasks such as texting, emailing, shopping and online banking, in a new study. The BCI does this without the need for...
NuVasive

NuVasive launches Cohere XLIF

NuVasive announced today the launch of their Cohere eXtreme Lateral Interbody Fudion (XLIF), a Porous PEEK interbody for use in XLIF and X360 surgeries. This is the first Porous PEEK interbody, and adds to NuVasive’s Advanced Materials Science (AMS) implant...
Astura Medical, Texas, USA, has received 510(K) clearance from the US Food and Drug Administration (FDA) for its Dolomite Stand-Alone Anterior Cervical Stabilization System. The Dolomite system allows for the choice between HA PEEK or Acid-etched Titanium interbody spacers in...
Medtronic has announced the completion of their acquisition of Medicrea, a platform which uses artificial intelligence (AI) to advance spinal surgeries. Medicrea solution uses predictive modelling and algorithms which measure and digitally reconstruct a patient’s spine, forming individualised patient...
Cerapedics today announced that the Canadian Market would be the first to have the i-FACTOR+ MATRIX surgical implant fully commercially available. The implant will be distributed by Surgi-One. A small proprietary peptide (p-15), a technology developed by Cerapedics, is...
Medtronic has received their US Food and Drug (FDA) 530(k) clearance of their NIM Vital nerve monitoring system. The NIM system helps physicians identify, confirm, and monitor nerve function, helping to reduce the risk of nerve damage during head...
The US Food and Drug Administration (FDA) has given clearance for the Nvision Trigon Stand-Alone Osteotomy wedge system, made from PEEK-OPTIMA HA Enhanced, a polymer from Invibio Biomaterial Solutions. Nvision paired with Invibo to create this product, which they claim...
A study published on the Global Spine Journal on 22 October, reports that 87.7% of spinal patients were satisfied with telemedicine appointments during the pandemic. A total of 772 patients participated in the survey across two practices in the USA....
Hyprevention has announced the first clinical cases performed in the USA with its V-Strut vertebral implant product to treat vertebral fractures. The US Food and Drug Administration (FDA) cleared V-Strut vertebral implant is indicated for use in the treatment of vertebral fractures due to osteoporosis or bone metastasis.   Two elderly patients presenting with...
LifeNet Health has launched, an allograft interbody spacer specifically designed for anterior cervical interbody system (ACIS) instrumentation, becoming the latest generation of its VertiGraft portfolio of allograft implants. The VertiGraft ACIS VG2 is comprised of a cancellous core and cortical...
Medtronic has announced the US launch of Adaptix interbody system, the first navigated titanium implant with Titan nanoLOCK surface technology, a proprietary blend of surface textures on the macro, micro, and nano levels. The announcement was made during the...
NuVasive has announced that results of the study, “Single-position prone lateral approach: cadaveric feasibility study and early clinical experience,” have been published in The Journal of Neurosurgery: Spine, which features NuVasive's MaXcess retractor and further validates prone, single-position lateral...