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...
The US Food and Drug Administration (FDA) has given Orthofix Medical 510(k) clearance for the nanotechnology feature of the Firebird SI fusion system, the 3D-printed titanium bone screw with nanotechnology designed to compress and stabilise the sacroiliac (SI) joint during fusion.  Orthofix is due to highlight their Nanovate technology, the nanotechnology feature of the Firebird SI fusion system, during the upcoming North American Spine...
The amount Medicare reimburses for orthopaedic trauma surgery has fallen by nearly one-third over the past two decades, according to a study in the Journal of Orthopaedic Trauma. “When adjusted for inflation, reimbursement for common procedures in orthopaedic trauma...
Nexxt Spine has announced the next generation of its standalone cervical system with the launch of Stand Alone Cervical Turn Lock (TL). The recently released TL system incorporates the dual functionality of a cervical interbody and anterior plate with...
Researchers from the University of Calgary, Canada, have developed and validated a clinical prediction scale that can be used to determine which patients are more likely to experience inadequate pain control following elective spine surgery. With this method, spine surgeons...
Cerapedics has announced Health Canada approval of the company’s next-generation bone graft called i-FACTOR+ Matrix, making it the first market to approve the commercial launch of the product. “We are excited to announce Canadian regulatory approval of our next-generation product,...
Wenzel Spine has announced that it has completed the acquisition of Statera Spine, a pre-operative diagnostics and quantitative data software solution that developed to aid treatment decisions for spine patients. Statera Spine is a software enabled spine imaging analytics company...
DiscGenics has announced that it has raised US$50 million in a Series C funding round led by Ci:z Investment with participation from new investors, Eagle Fund SP1 LLP, Medical Incubator Japan (MIJ), and CareNet of Japan. Major follow-on investments...
Researchers from The Mount Sinai Hospital (New York, USA) have designed a new X-ray classification system for adult idiopathic scoliosis that can more precisely define which parts of the spine need correction, which could enhance treatment, communication, and analysis...
Atlas Spine has announced the launch of its HiJAK SA expandable cervical standalone interbody system, the company’s second first-to-market expandable system in 18 months. The first implantation of the HiJAK SA expandable standalone system was performed by neurosurgeon Grant A...
The use of electrical and magnetic stimulation simultaneously has shown promising results and even helped a spinal cord injury patient regain the ability to walk.   The simultaneous stimulation of the motor nerves of the brain and limbs (paired associative stimulation), has yielded promising...
Bilateral L4 dorsal root ganglion (DRG) stimulation has been shown to evoke strong and reproducible motor responses in the upper leg in patients with chronic motor complete spinal cord injury (SCI). In their paper published in Neuromodulation, authors Sadaf...
Life Spine has announced that it has received clearance from the US Food and Drug Administration (FDA) to market the PLATEAU-A Ti Anterior Lumbar Spacer System. “With the increased usage of anterior column reconstruction, PLATEAU-A Ti fills an important portfolio...
As hospitals begin to resume elective procedures, the Children’s Hospital of Philadelphia (CHOP) have outlined a framework for prioritising paediatric spine surgeries during the COVID-19 pandemic. As the global health crisis took hold, hospitals across the USA cancelled elective procedures...
A new study published in Interdisciplinary Neurosurgery shows Neo Medical's controlled fixation platform saves costs due to significantly decreased expenses for processing, logistics, decreased rates of contaminated instruments, less operating room (O.R) delays, and potentially lower revision and infection...
Open posterior lumbar interbody fusion should be avoided in the management of lumbar degenerative disc disease (LDDD), concludes a recently published systematic review. The authors, Kuan-Yu Chi and colleagues from Taipei Medical University Hospital, Taipei, Taiwan, write that open posterior lumbar interbody fusion yields a...
joimax has announced a new partnership with Australian medical device distributor, LifeHealthcare. The two companies have entered into a long-term relationship to provide a broader surgical choice for patients considering spinal surgery. “We’re looking forward to working with a partner...
  Zavation Medical Products has announced the launch of both the Z-Span Expandable Anterior Lumbar Plate and the Z-Span Expandable Lateral Lumbar Plate, plates designed for use in the lumbar spine as supplemental fixation devices. The Expandable Anterior Lumbar Plate is...
A study presented as part of the AAOS 2020 Virtual Education Experience has found that topical steroids administered during anterior cervical discectomy and fusion (ACDF) surgery help reduce swallowing difficulties following the procedure. The findings were presented by lead...
7D Surgical has announced that it has achieved CE mark certification for its Machine-vision Image Guided Surgery (MvIGS) system for spinal surgery. This achievement clears the way for 7D Surgical to commence commercialisation efforts of its spinal platform across...
Cerapedics has announced that the US Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) supplement, reducing the enrolment requirement for the ongoing clinical trial, ASPIRE, for P-15L Bone Graft in a single level transforaminal...
Medtronic has entered into a tender offer agreement for the acquisition of all outstanding shares of Medicrea, a developer of artificial intelligence software, predictive modelling and patient specific implants for spinal surgery. The friendly voluntary all-cash tender offer will...
The use of robots to assist in spinal surgery carries a higher complication burden in the introductory phase as surgeons overcome the learning curve associated with the technology, according to a study presented at the 27th Annual Meeting on...
ulrich medical USA has announced the US nationwide commercial release of the Momentum posterior spinal fixation system. The new Momentum rod-screw system includes polyaxial, reduction, and iliac screws, and is compatible with ulrich medical USA's neon3 Universal OCT spinal stabilisation...
With the 2020 edition of the Annual Meeting on Advanced Spine Techniques (IMAST 2020; July 6–December 31) being the meeting’s first ever digital-only event, IMAST chair Han Jo Kim (Hospital for Special Surgery, New York) talks to Spinal News...
Using intrathecal morphine following surgical treatment of adolescent idiopathic scoliosis patients reduces hospital costs, yields better postoperative pain control and results in a significantly lower opioid requirement than patient-controlled analgesia, according to a study presented as part of the...
Initial results of a US Investigational Device Exemption (IDE) trial studying use of a novel paraspinous tension band (LimiFlex, Empirical Spine) for the treatment of degenerative spondylolisthesis have been presented online as part of the 27th Annual Meeting on...
A study published in the July issue of the Journal of the American Academy of Orthopaedic Surgeons (JAAOS) has found a correlation between patient-reported pain at discharge from inpatient surgery and the number of opioids prescribed during the 90-day...
EOS imaging has announced the first installation of its EOSedge platform in Germany at the Asklepios Clinic St Georg in Hamburg. This follows the installation of EOSedge systems in France and North America. “EOSedge brings an innovative breakthrough for musculoskeletal...
Findings of a multicentre, prospective study conducted through the International Spine Study Group (ISSG) and presented at the 27th Annual Meeting on Advanced Spine Techniques (IMAST 2020) have detailed the complication rates associated with surgical treatment of adult cervical...
Spinal Elements has announced US Food and Drug Administration (FDA) clearance of the Sapphire X device for anterior cervical fixation. Sapphire X is the newest product in its MIS Ultra suite of products aimed at minimising the unintended...
Jean-Pierre Mobasser, Robert Hastings and Dillon Mobasser of the Goodman Campbell Brain and Spine Institute (Indianapolis, USA) and Indiana Spine Hospital (Carmel, USA) share their experience of and strategy for peri-surgical opioid management in spinal surgery patients. The opioid crisis...
The North American Spine Society (NASS) has cancelled its 35th Annual Meeting, which had been due to take place in San Diego, USA, between 7–10 October due to the ongoing COVID-19 pandemic. The event will instead transition to a...
SeaSpine has announced the full commercial launches of Mariner MIS and Mariner Outrigger spinal fixation systems. “The commercial launches of Mariner MIS and Mariner Outrigger result from meticulous product refinement and creative application of differentiated features,” said Keith Valentine, president...
Many studies published in major spinal surgery journals do not include the full disclosure of researchers’ financial conflicts of interest (COIs), according to a study published in Spine. Authors of the study have called for a standardisation of definitions...
CoreLink has announced the commercial launch and 510(k) clearance from the US Food and Drug Administration (FDA) for the F3D-C2 standalone cervical system. The system is comprised of an additively manufactured spacer with two bone screw anchors secured by a...
Orthofix has announced US Food and Drug Administration (FDA) 510(k) clearance and the first patient implants of the Firebird SI fusion system. The system is designed to compress and stabilise the sacroiliac (SI) joint during fusion, and is the...
A study comparing short-term outcomes of minimally invasive (MI) lumbar decompression surgery to MI lumbar spine fusion surgery found no statistically significant difference in the amount of time patients needed to return to work. Researchers at Hospital for Special Surgery...
Mainstay Medical has announced that the US Food and Drug Administration (FDA) has approved the company’s premarket approval (PMA) application for ReActiv8, its implantable neurostimulation system to treat intractable chronic low back pain. “ReActiv8 is designed to be a restorative...
SeaSpine has announced the limited commercial launches and completion of initial surgeries of both its NorthStar OCT and Cervical Facet Fusion systems, expanding its procedural offerings for posterior cervical fusion. The NorthStar OCT system brings to market a posterior cervical...

Daniel Riew

One of the world’s foremost specialists in the treatment of the cervical spine, Daniel Riew talks to Spinal News International about his illustrious career. Riew, who has served as the President of the Cervical Spine Research Society (CSRS), and...
Robot-assisted technology was found to be superior to freehand techniques for the placement of pedicle screws in a systematic review and meta-analysis of seven randomised controlled trials involving spinal surgery. However the analysis, published in the Global Spine Journal,...
NuVasive has today announced the expansion of its complex spine portfolio with the global commercial availability of Reline 3D, a posterior fixation system for patients suffering from paediatric spinal deformities. The Reline 3D system is optimised for the treatment of...
Sirakoss, a developer of nanosynthetic bone graft substitutes, announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for Osteo3 ZP Putty, a nanosynthetic bone graft substitute. Osteo3 ZP Putty has been designed...
An editorial published in The Spine Journal details a series of strategies to mitigate the mental health impact of the provision of spine care during COVID-19. Authored by Victoria Williamson (King’s College London, London & University of Oxford, Oxford,...
The Scoliosis Research Society (SRS) has announced that its 55th annual meeting, which had been due to take place from 9‒12 September, in Arizona, USA, has been switched to a virtual platform due to the COVID-19 pandemic. In a statement...
Augmedics has announced that its xvision Spine System (XVS), augmented reality guidance system has been successfully used for the first time in a spinal fusion surgery in the USA. The system was used in a spinal surgery procedure by surgeons...
OrthoPediatrics has announced the initial launch of the ApiFix minimally invasive deformity correction system in the USA. Additionally, the company anticipates approximately 20 clinical centres in the country to enter data related to the use of the ApiFix system into...
MiRus has announced that it received US Food and Drug Administration (FDA) 510(k) clearance for its 3DR (randomised) printed lumbar interbody fusion system which consists of the Callisto 3DR PLIF, Hyperion 3DR TLIF, Calypso 3DR LLIF and the Antares...
4WEB Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Stand-Alone Anterior Lumbar Interbody Fusion Device (ASTS-SA). The new design allows fixation screws to be placed through the truss implant and into the...
Relievant Medsystems has announced the publication of long-term data from the Level I SMART trial showing durability of improvements in pain and function beyond five years for patients treated for chronic low back pain with the Intracept procedure. The...
Microscope-based augmented reality (AR) can be applied successfully to various kinds of spinal procedures, and improves anatomical orientation during surgery, as well as offering potential as a tool for education, a study published in the Global Spine Journal has...
Highlights: Surgeons face pent-up demand for spinal procedures following COVID-19 elective shutdown (pages 1–2) Artificial intelligence in spine care is “here to stay” (pages 1–4) Profile: Daniel Riew (pages 8–9) Feature: Vertebral body tethering (pages 10–11)
Highlights: Surgeons face pent-up demand for spinal procedures following COVID-19 elective shutdown (pages 1–2) Artificial intelligence in spine care is "here to stay" (pages 1–4) Profile: Daniel Riew (pages 8–9) Feature: Vertebral body tethering (pages 10–11)
Standard pedicle screw handling techniques lead to contamination of screws and therefore the screw-bone interface, according to the findings of a prospective multicentre study published in the Clinical Spine Surgery Journal. The study’s corresponding author, Aakash Agarwal (University of...
SpineGuard, has filed a 510(k) regulatory dossier with the US Food and Drug Administration (FDA), seeking authorisation to commercialise its Dynamic Surgical Guidance (DSG) sensing technology, DSG Connect platform, in the USA. The sensing technology is used to secure...
Meditech Spine has received US Food and Drug Administration (FDA) 510(k) clearance to market the CURE Opel-L (S) system, a new lumbar plate option. The new system expands upon the previously cleared CURE LP plate system and compliments its Talos-A...
Eurospine 2020, which had been due to take place in Vienna, Austria from 6–9 October, will instead be a digital event, organisers have announced. The online congress will be CME accredited and take place over the same dates as the...
Nexxt Spine has announced US Food and Drug Administration (FDA) 510(k) clearance of two lumbar based systems, for anterior lumbar interbody fusion (ALIF) and lateral approaches. The milestone will allow the company to commence in-house manufacturing of the two systems...
Centinel Spine has announced US Food and Drug Administration (FDA) approval for the manufacturing transfer of both the prodisc C Cervical Total Disc Replacement and prodisc L Lumbar Total Disc Replacement systems to new strategic vendors. The FDA approval for...
Yingda Li and Michael Wang consider the increasing interest in endoscopic techniques in spinal surgery. The authors describe how endoscopic techniques have been incorporated into practice at the University of Miami, and discuss  how they can be used successfully...
The full findings of a global survey of spinal surgeons on the impact of the COVID-19 pandemic have been published in the Global Spine Journal, and point to “elevated anxiety, uncertainty for the future and the need for standardised...
Cerapedics has announced the publication of results from a clinical trial evaluating i-FACTOR Peptide Enhanced Bone Graft in non-instrumented lumbar fusion surgery in The Spine Journal. The data demonstrate that elderly patients in Denmark treated with i-FACTOR bone graft...
Jonathan Rasouli (Cleveland Clinic, Cleveland, USA) details discussions at the Virtual Global Spine Conference (May 5), which hosted key opinion leaders to discuss the impact of COVID-19 on national education initiatives in spine care. The ongoing COVID-19 pandemic has had...
Neo Medical has announced the closing of a US$13.4 million (CHF 13.2 million) financing round. The funds will be used to finance the company’s global growth and expansion in targeted key markets, Neo Medical said in a press release. Neo...
Precision Spine has launched the Slimplicity HP anterior cervical plating (ACP) system in the USA, which has been designed to enable surgeons to accommodate diverse patient anatomies and pathologies with low profile constrained, semi-constrained or hybrid constructs. The Slimplicity HP...
Camber Spine has announced US Food and Drug Administration (FDA) clearance and the nationwide launch for two novel anterior cervical devices, the SPIRA C-Integrated Interbody system, a standalone integrated fixation system, and the FORTICO Anterior Cervical Plating System, a...
NuVasive has announced the expansion of its Advanced Materials Science (AMS) implant portfolio with the commercial launch of the Modulus XLIF dual sided plate, and the receipt of 510(k) clearances from the US Food and Drug Administration (FDA) for...
A study of the use of virtual visits for paediatric spinal deformity patients suggests that telemedicine can provide faster care for patients, with comparable satisfaction. The findings of the study, published in the Journal of Pediatric Orthopaedics, should provide...
Astura Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its El Capitan Anterior Lumbar Interbody Fusion (ALIF) System. El Capitan was designed to provide the widest array of interbody and fixation options, along with...
VIVEX Biologics has announced that the initial clinical trial results of the VAST Trial evaluating VIA Disc were published in The International Journal of Spine Surgery. The paper was the first-ever published 12-month results from Level 1 intradiscal study...
Prism Schneider (Cumming School of Medicine, University of Calgary, Calgary, Canada) and others write in a commentary in the Canadian Medical Association Journal—because of an increase in domestic violence during the pandemic—healthcare providers should be aware of the signs...
On 18 March, the Centers for Medicare & Medicaid Services (CMS) recommended “limiting non-essential care and expanding surge capacity into ambulatory surgical centres and other areas” to conserve resources and staff for managing COVID-19 patients. However, in a statement...
The last decade proved to be a turning point in the use of advanced technologies in spinal surgery, with developments in areas such as robotics for screw placement, computer-assisted navigation and new techniques for minimally invasive surgery all moving...
Training of spine fellows has been impacted but not diminished as a result of the COVID-19 pandemic, according to a paper published online in The Spine Journal. Authored by James E Dowdell and colleagues from the Department of Orthopedic...
Alphatec Holdings (ATEC) has terminated the tender offer agreement (TOA), dated 26 February 2020, under which it was to acquire EOS imaging for up to US$88 million in a combination of cash and equity. EOS imaging is a specialist in...
Telemedicine and virtual consultations are becoming increasingly prevalent in spine care, as healthcare providers seek to adapt practices amid the pandemic. A recent Scoliosis Research Society (SRS) webinar, moderated by Suken A Shah (Wilmington, USA), explored leveraging technology in...
Atlas Spine has announced US Food and Drug Administration (FDA) clearance for the HiJAK SA expandable standalone cervical interbody system. HiJAK SA joins first-to-market HiJAK AC and the V3 segmental plating system as the latest technology in Atlas Spine’s disruptive...
Life Spine has announced that it has received clearance from the US Food and Drug Administration (FDA) to market the PROLIFT Lateral Fixated system. “PROLIFT Lateral Fixated combines the innovation of the SENTRY Lateral Plate with the technology of the...
Precision Spine has announced the US launch of the Reform MC (midline cortical) system, a top-loading, multiple component, posterior spinal fixation system which consists of cannulated pedicle screws, straight and lordotic rods, and locking cap screws. The Reform MC...
Nexxt Spine has announced the first effective implantation of the Nexxt Matrixx corpectomy system following US Food and Drug Administration (FDA) clearance. The corpectomy cage is an intentionally-engineered 3D printed porous titanium implant. The surgery was performed by Derek Taggard...
Astura Medical has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Sirion lateral lumbar interbody fusion (LLIF) system. From initial access with the retractor to the interbody and plating options, the...
As the world’s healthcare communities continue to lead efforts to tackle the COVID-19 pandemic, non-essential procedures in a number of fields, including spine care, have been scaled back to preserve resources and protect patients. Speaking to Spinal News International,...
Over 900 spinal surgeons have contributed to research looking at the impact of the COVID-19 pandemic on their practice, with concerns over availability of personal protective equipment (PPE), and the long term economic and health impacts of curtailment of...
In a brief report in Annals of Internal Medicine, Seongman Bae (Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea) and colleagues report that neither surgical nor cotton masks appear to be an effective approach for preventing the dissemination of SARS-CoV-2 from...

Alex Vaccaro

Alex Vaccaro is the immediate past president of the Cervical Spine Research Society (CSRS) and a member representative for AO Spine. He talks to Spinal News International about his career in spine care, how the field has changed since...
Artificial intelligence (AI) has “tremendous potential” to revolutionise comprehensive spine care across areas including patient selection, outcome prediction, research, pre-operative workup and peri-operative assistance, the authors of a large systematic review on the topic have found. Published in the Global...
Tissue Differentiation Intelligence (TDi) has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for the SonoVision ultrasound platform, designed for intraoperative access to the spine. SonoVision applies layers of image-processing algorithms to ultrasound images collected...
Centinel Spine has announced US Food and Drug (FDA) approval of two-level indications for the prodisc L lumbar total disc replacement (TDR) system. Centinel Spine now becomes the only company in the world with an FDA-approved lumbar TDR device...
Signus has announced that it has received CE mark approval for two implants in its product portfolio, the BIG ST anterior lumbar interbody fusion (ALIF) cage and the JASPIS ST cervical cage. BIG ST is a 3D printed lumbar cage,...
Royal Philips has announced that the US government and Philips agreed to team up to increase the production of hospital ventilators in its manufacturing sites in the USA. Philips plans to double the production by May 2020  and achieve...
Precision Spine has launched worldwide the Reform Ti titanium pedicle screw system, designed to provide increased flexibility, versatility, and visibility to take on challenging degenerative and trauma spine procedures. The Reform Ti system features a titanium tulip and a triple...
Stryker has announced the development of a limited-release emergency response bed to quickly aid healthcare providers with efficient care during the COVID-19 pandemic. The Emergency Relief Bed is a low-cost solution intended to serve frontline healthcare providers. It includes a...
NuVasive has suspended the supply of all Magec rods to the UK and Ireland while the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) reviews the continued use of the device. An urgent field safety notice issued by the manufacturer...
The European Commission (EC) has adopted a proposal to postpone by one year the date of application of the new Medical Devices Regulation (MDR), which was due to come into force on 26 May this year. The postponement, a press...
In a new statement published on 2 April 2020, all 45 societies represented by the US Council of Medical Specialty Societies (CMSS)—over 800,000 physicians—emphatically declare their belief that all frontline healthcare professionals must have access to personal protective equipment...
OrthoPediatrics acquired ApiFix Ltd, including its minimally invasive deformity correction (MID-C) system for non-fusion treatment of progressive adolescent idiopathic scoliosis (AIS). The transaction has been agreed for 934,768 shares of OrthoPediatrics common stock and US$2 million in cash paid at...
Highlights: Starker than expected radiation from fluoroscopy in TLIF surgery Highlights from ISASS 2020 Profile: Alex Vaccaro Lawrence Lenke discusses technology and the changing role of the spinal surgeon Technological developments in spinal surgery to look out for during...
Highlights: Starker than expected radiation from fluoroscopy in TLIF surgery Highlights from ISASS 2020 Profile: Alex Vaccaro Lawrence Lenke discusses technology and the changing role of the spinal surgeon Technological developments in spinal surgery to look out for during...
The American College of Surgeons (ACS) today leapt to the defense of healthcare workers who are heading to work in the face of increasing concerns over personal protective equipment (PPE) shortages as the COVID-19 pandemic cuts trails across the...
SpineGuard has announced that it has received the CE mark for the commercial release of its DSG Connect platform. Already being utilised experimentally in a new strategic high value platform to guide surgical robots, SpineGuard will now apply this platform...
Nexxt Spine has announced US Food and Drug Administration (FDA) 510(k) clearance of the Nexxt Matrixx corpectomy system. The Nexxt Matrixx corpectomy system has been cleared for use in the cervical spine (C2-T1) and thoracolumbar spine (T1-L5) in skeletally mature...
OrthoPediatrics has received 510(k) clearance from the US Food and Drug Administration (FDA) to expand the indications for its Response scoliosis system to include neuromuscular implants. This 510(k) clearance represents a significant milestone in the company’s development toward its next...
A study of patients with chronic sciatica caused by lumbar disc herniation has found that microdiscectomy is superior to conservative non-surgical care with respect to pain intensity at six months of follow-up. This was the conclusion drawn by researchers...
During a Q&A section of a European Commission (EC) college meeting on 25 March, EC spokesperson Stefan de Keersmaecker stated that the commission were looking to delay the “entry into force” of the new European medical device regulations (MDR) because of...
Currently with Europe’s highest number of confirmed cases of the novel coronavirus COVID-19, Italy’s healthcare services have been forced to adopt drastic and wide-ranging measures to cope with the epidemic. Speaking to Spinal News International, Pedro Berjano, an orthopaedic...
A viewpoint in the Journal of the American Medical Association (JAMA) has offered potential solutions to modifying ongoing randomised clinical trials during the COVID-19 pandemic. It aims to “minimise disruption and preserve integrity”, while still ensuring participant health and...
AgNovos Healthcare has announced that its newest investigational product, AGN1 Local Osteo-enhancement Procedure (LOEP) Small Volume (SV) Kit, has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA). If cleared by the FDA, the AGN1 LOEP...
The North American Spine Society (NASS) is issuing a call for papers for NASSJ, a new open access journal. NASSJ aims to facilitate the dissemination of knowledge about clinical care, research and education more effectively and efficiently by offering...
The American College of Surgeons (ACS) has published guidance for surgeons to curtail recommendations for elective surgical procedures to preserve resources for the care of critically ill patients during the COVID-19 pandemic. To assist in surgical decision-making in curtailing cases,...
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has written to the medical device industry to outline its response to the COVID-19 public health emergency in its day-to-day operations with industry. The letter from...
The North American Spine Society (NASS) has set up a dedicated section on its website to keep spine care providers up to date on practice and regulatory measures to be taken into account due to COVID-19.  In a letter posted on...
Global efforts to tackle the spread of Novel Coronavirus (COVID-19) have seen spine care providers advised to cut back to all but essential procedures to free up resources for healthcare providers in response to the outbreak. The US Centers for...
Life Spine a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders has announced a partnership with Gizmo Medical for the production of surgical masks and gowns to meet demand in...
Precision Spine has nationally launched the SureLOK MIS 3L percutaneous screw system in the USA. The SureLOK system can be used in a number of minimally invasive surgery (MIS) approaches. In a press release, Precision Spine said that the system...
NuVasive has issued an urgent field safety notice for the recall of Magec System Model X rods. The notice, issued on 13 February, indicates that separation of an actuator end cap component has been observed in around 0.5% of...
A research collaboration led by Cornell University (Ithaca, USA) professor Lawrence Bonassar has led to the development of a new technique for the treatment of a herniated disc, repairing the disc “like a flat tyre”. The team’s paper describing the...
Steven Glassman charts the development of bone morphogenetic proteins (BMPs) and their use in spinal procedures, as well as current and future uses. BMP was discovered by Marshall Urist, and first reported in Science in 1961. A company named Genetics...
A study of radiation exposure among patients undergoing transforaminal lateral interbody fusion (TLIF) surgery presents a “starker than expected” difference in dosage between patients having intraoperative fluoroscopy-guided procedures than those aided by image-guided navigation (IGN) or robotic assistance. The findings...
Frank Phillips (Rush University Medical Center, Chicago, USA) was named president of the International Society for the Advancement of Spine Surgery (ISASS) during the society’s 2020 annual meeting (ISASS20; 26–28 February, Puerto Rico, USA). Phillips is the director of the...
Centinel Spine has announced Steven F Murray as CEO, effective March 16, 2020, succeeding the current chairman and CEO John J Viscogliosi. “As a founder, chairman and CEO of Centinel Spine over a decade ago through the merger and acquisition...
NuVasive has announced the results of a study supporting the use of Attrax Putty as a standalone bone graft substitute for autograft in instrumented thoracolumbar posterolateral lumbar fusion (PLF). The study, “Efficacy of a standalone microporous ceramic vs. autograft...
A number of spine meetings scheduled for the first half of 2020 have been cancelled in light of the coronavirus outbreak. The Scoliosis Research Society (SRS) has taken the decision to cancel the International Meeting on Advanced Spine Techniques (IMAST)...
Following on from studies examining the socioeconomic and racial factors influencing the outcomes from spinal surgery, Jonathan Rasouli (Cleveland Clinic, Cleveland, USA) and colleagues have sought to stratify the outcomes from anterior cervical fusion surgery (ACDF) surgery based upon...
Biogennix has received US Food and Drug Administration (FDA) 510(k) clearance for an expanded indication for its Agilon moldable bone grafting product. The expanded indication clears Agilon for use in posterolateral spine procedures when mixed with autograft. Biogennix designed Agilon...
DiscGenics has completed enrolment in its Phase 1/2 first-in-human US clinical study of an allogeneic, injectable Discogenic Cell therapy (IDCT) for degenerative disc disease (DDD). The prospective, randomised, double-blinded, vehicle- and placebo-controlled, multicentre clinical study is designed to evaluate the...
Life Spine has received an additional clearance from the US Food and Drug Administration (FDA) to market the Lateral PROLIFT expandable system. The company also announced that they are slated to launch 20 new products, including six micro invasive...
The AO Foundation and icotec ag have announced an agreement for the joint development of a new spinal stabilisation system based on icotec's proprietary BlackArmor Carbon/PEEK composite implant material. “The AO is delighted to partner with icotec ag, and to...
Integrity Implants has announced positive data from a retrospective study demonstrating favourable fusion efficacy with its FlareHawk interbody implant. The study, ‘Transforaminal/posterior lumbar interbody fusion with the FlareHawk expandable interbody fusion device,’ was led by principal investigator Domagoj Coric,...
Preliminary results of an Investigational Device Exemption (IDE) study into two-level cervical total disc replacement (TDR) using a polyetheretherketone (PEEK)-on-ceramic implant (Simplify Medical), showed that the device is associated with significant decreases in pain and disability scores. The findings were presented...
The percentage of patients using opioid medication once or more a day after receiving the Prestige LP cervical disc arthroplasty (CDA) (Medtronic) was statistically lower than those undergoing two-level anterior cervical discectomy and fusion (ACDF), according to 10-year follow-up...
The use of a polyetheretherketone (PEEK) cervical disc allows for significantly improved visualisation of surrounding spinal and neuro structures on postoperative magnetic resonance imaging (MRI) scans compared to metal implants. This is according to results presented by Domagoj Coric...
Alphatec Holdings (ATEC) has announced that it has entered into an agreement to acquire EOS imaging for a purchase price of up to US$88 million, plus debt retirement of US$33.9 million, in a combination of cash and equity. EOS imaging...
DeGen Medical has announced the first implant of the E3 MIS pedicle screw system at Texas Back Institute in Plano, USA. The minimally invasive procedure was recently performed by Peter Derman, a minimally invasive and endoscopic spine surgeon at...
RTI Surgical will showcase its body of clinical data on the SImmetry sacroiliac joint fusion system at the 2020 International Society for the Advancement of Spine Surgery annual meeting (ISASS20; February 26–28, Puerto Rico, USA). Interim results on 50 patients...
Enrolment has begun in the USA for a new patient study featuring two artificial cervical discs designed by spinal device manufacturer Centinel Spine, the prodisc C Vivo and prodisc C SK. The two discs will be compared to the...
A retrospective review of patients undergoing instrumented spinal surgery has concluded that the use of image-guided navigation may offer an advantage compared to fluoroscopy-assisted and freehand screw placement. This was the finding of James Towner (University of Rochester Medical...
Genesys Spine has announced the launch of its Sacroiliac Joint Fusion system. The system consists of partially threaded and fully threaded implants designed to secure the sacroiliac joint and minimise micro-motion enabling bony fusion. In a press release, Genesys Spine...
Michael Vitale (New York Presbyterian, New York, USA) chairs the Safety in Spine Surgery Summit annual meeting, as well as having co-authored a book on the topic, Safety in Spine Surgery. Ahead of the fifth annual Safety in Spine...
CTL Amedica Corporation has been granted an official patent from the US Patent and Trademark Office for a screw offset blocking mechanism, which has been designed for and implemented in the company’s MONET Anterior Cervical Fusion System. CTL Amedica plans...
NuVasive has announced the results of a study published in The European Spine Journal, validating the versatility of its MaXcess retractor in prone, single-position eXtreme Lateral Interbody Fusion (XLIF) and posterior fixation. In the prospective, comparative study, peri-operative outcomes were...
Orthofix Medical has announced US Food and Drug Administration (FDA) approval of the STIM onTrack mobile app version 2.1 for use with the company’s bone growth stimulators. The STIM onTrack technology works with the Orthofix Bone Growth Therapy devices. The...
A ten-year analysis of adults presenting with previously untreated adolescent idiopathic scoliosis (AIS) has found that patients with unoperated AIS reported low assessment scores for pain, self-image and function in adulthood and scored similar to age-match controls without AIS....
Inspan LLC has announced results from a long-term follow-up clinical study of outpatient L4-L5 lumbar interspinous fixation for degenerative spinal stenosis using the Inspan interspinous fixation device. In a press release, Inspan said that the device fixates the spine...
Medicrea has received US Food and Drug Administration (FDA) clearance for UNiD IB3D patient-matched interbody cages which completes its UNiD ASI (adaptive spine intelligence) platform technology. UNiD IB3D patient-matched interbody cages are 3D-printed titanium implants which allow customisation of the...
The use of peri-operative pregabalin does not reduce the postoperative opioid consumption or pain scores in adolescents after posterior spinal fusion surgery,  a double-blinded, placebo-controlled, randomised clinical trial has concluded. Findings from the trial, which was authored by Linda...
Life Spine has announced that it has received 510(k) clearance from the US Food & Drug Administration (FDA) to market the Steerable Plateau Ti system. The Steerable Plateau Ti System is available in lengths of 28mm and 32mm and heights...
Virtual reality, including 3D imaging, will play an increasing role in planning complex spinal deformity surgery in the near future, according to Lawrence Lenke (Division of Spinal Surgery, New York-Presbyterian Och Spine Hospital, New York, USA). At the 5th...
Globus Medical has announced the first procedure using the Hedron IA implant, a 3D printed integrated ALIF spacer that leverages anchors or screws for vertebral body fixation. The minimally invasive outpatient procedure was performed at Englewood Health (Englewood, New...
7D Surgical has announced the commercial release of its Universal Tracking Kit which spine surgeons can use to track and visualise almost any rigid surgical instrument on the MvIGS system, including third party vendor taps and screwdrivers. The 7D Surgical...
The North American Spine Society (NASS) has released a guidance document, Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and treatment of low back pain, to assist practitioners who treat adult patients with non-specific low back pain above the...
Surgeons should consider removal or replacement of implants following adult spinal deformity (ASD) surgery only in cases where there is recurrent infection or evidence of osteolysis—but rarely in the case of initial acute infections. This was the message from...
Atlas Spine has announced the launch of its V3 guided segmental plating system, expanding the company’s technology solutions for treating complex deformity and degenerative conditions of the cervical spine. In October 2018, the company introduced HiJAK AC, which it described...
  Life Spine has announced today the publication of a white paper examining the immediate restoration of patient disc height, foraminal height and lordosis with the ProLift expandable spacer system. This white paper is one of many papers and studies...
Investigators have found that nanocoated polyetheretherketone (PEEK) cages for posterior lumbar interbody fusion (PLIF) achieve a better fusion rate than uncoated PEEK cages at one year follow-up—while also having similar safety and efficacy outcomes. These are the conclusions of...
  EOS imaging has announced the first installation of its new EOSedge system in North America at CHU Sainte-Justine Mother and Child University Hospital Centre in Montreal, Quebec, Canada. This second EOSedge system installation worldwide follows the first system install in...
Inspired Spine has reached the milestone of completing 1,000 Oblique Lateral Lumbar Interbody Fusion (OLLIF) procedures. According to a press release issued by the company, the minimally invasive surgical technique is designed to improve the performance of lumbar interbody fusions...
CoreLink has announced the implantation of over 5,000 3D printed devices using its proprietary Mimetic Metal technology. Mimetic Metal is an additively manufactured technology that combines a lattice framework and inner trabecular pores to emulate the structural, functional and physiological...
Synaptive Medical has announced the US and Canadian availability of updates to its flagship surgical technology product, Modus V, a fully automated robotic digital microscope designed to assist surgeons in the operating room. The latest product updates add 3D visualisation...
Black patients undergoing lumbar spinal fusion surgery have worse outcomes—including higher complication rates, more hospital days, and higher costs—compared to white patients, a study published in Spine suggests. The study team led by Robert S White, (New York Presbyterian Hospital,...
UCB Canada has announced that CIMZIA (certolizumab pegol) for the treatment of adults with severe active non-radiographic axial spondyloarthritis (nr-axSpA), has been approved for use by Health Canada. The treatment is targeted at adults with objective signs of inflammation as...
The Medicrea Group has announced that it is in active discussions with potential US strategic partners in the spine industry with the intention to execute one or more strategic agreements that could materialise through a takeover of the company,...
  Cutting Edge Spine has received 510(k) clearance from the US Food and Drug Administration (FDA) for its EVOL ha-DLIF direct lateral interbody fusion system. The EVOL ha-DLIF is made of PEEK-Optima HA-enhanced material supplied by Invibio Biomaterial Solutions. Cutting Edge...
A review of bleeding and thrombotic complication rates in elective spine surgery patients has suggested that further study is needed to “define the role” of routine deep vein thrombosis (DVT) chemoprophylaxis following elective spine surgery. This is the conclusion...
Medtronic has issued a field safety notice over its Mazor X Surgical System, after reports that certain versions of the device had unexpectedly disconnected from operating tables having been securely attached. The Mazor X Surgical System is a robotic assisted...
Bone Biologics has announced that it has completed a preclinical study, which shows that its rhNELL-1 growth factor effectively promotes bone formation in a phylogenetically advanced spine model. In addition, rhNELL-1 was shown to be well tolerated and there...
IDCT (DiscGenics) has passed the initial safety review of its double blinded clinical study evaluating the allogenic, injectable disc cell therapy in Japanese patients with mild to moderate degenerative disc disease (DDD), DiscGenics has announced. IDCT is a homologous, allogeneic,...
Medicrea has announced that the US Patent Office has recently issued the company seven additional patents related to the UNiD ASI proprietary technology platform. The company’s proprietary UNiD ASI technology is powered by artificial intelligence (AI) and is designed to...
Changes in patient-reported outcome measure (PROM) scores must be considerable in order to distinguish a true change from random error in degenerative lumbar spine surgery research, a paper published in the European Spine Journal has found. Authored by Catharina...
Intraoperative neuromonitoring (IONM) was introduced several decades ago and is an increasingly favourable option for delicate surgeries. A recent study1 indicates that IONM procedures have risen 296% from 2008–2014. So, what is it and how does it benefit spine...
Nuvasive has announced the appointment of Matthew K Harbaugh as executive vice president and chief financial officer (CFO) effective immediately. Harbaugh succeeds Rajesh J Asarpota, who will transition from the company.  In a press release, NuVasive said that Harbaugh brings...
SeaSpine has announced the full commercial launch of the Mariner Midline posterior fixation system. Mariner Midline is described by SeaSpine as a comprehensive, less invasive posterior fixation system built upon the Mariner platform to simplify the treatment of a wide...
Augmedics has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its xvision Spine system (XVS), an augmented reality (AR) guidance system to be used in spine surgery. The xvision consists of a transparent near-eye...
Life Spine announced today that it has received clearance from the US Food and Drug Administration (FDA) to market the titanium stand-alone ALIF spacer system. The Titanium Stand-Alone ALIF System comes in footprints of 34mm x 24mm, 38mm x 28mm...
Margareta Nordin in spine care

Margareta Nordin

In a career spanning several decades, Margareta Nordin has gained renown for her evidence-based approach to spine care. She talks to Spinal News International about how her early career and education has shaped her thinking. When did you know you...
Spine surgery in patients of advanced age is safe to perform as older age itself is not a risk factor, surgeons from seven institutions in Japan have concluded following a multicentre, prospective study of surgeries performed in patients 80...
RTI Surgical has announced the publication of a study evaluating the in-vivo material characteristics of 3D-printed Polyetherketoneketone (PEKK), TETRAfuse 3D spinal interbody implants compared to Polyetheretherketone (PEEK) and Titanium-coated PEEK (Ti-coated) technologies. ‘A comparative study of three biomaterials in...
Aurora Spine has announced the appointment of Jana F Kiena as chief financial officer, effective 17 December 2019. Kiena will help guide and oversee the company’s continued market leadership and financial growth, Aurora Spine said in a press statement. She...
Patient-reported functional outcomes vary considerably after lumbar spinal fusion surgery, a study conducted by David Flum (University of Washington Surgical Outcomes Research Center; Washington; USA) and colleagues has found. But, the variability mainly reflects patient characteristics, rather than differences...
ulrich medical USA has announced the commercial release of its inaugural rod-screw system, the Momentum posterior spinal fixation system.  The Momentum System addresses a comprehensive list of surgical reconstruction needs and includes polyaxial, reduction, and iliac screws, ulrich medical USA...
Empirical Spine has announced completion of enrolment in the investigational arm of its US Investigational Device Exemption (IDE) trial studying the use of the paraspinous tension band LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar...
Outgoing North American Spine Society (NASS) president Jeffrey Wang (Keck School of Medicine, Los Angeles, USA) talks to Spinal News International about the organisation’s increasing international focus, highlights from the society’s 34th annual meeting (NASS 2019; 25–28 September, Chicago,...
Topical application of tranexamic acid (TXA) before wound closure has been found to have better postoperative blood conserving effects in elective spine surgery, compared to intravenous administration and local infiltration of the drug. This is the finding of a...
RTI Surgical Holdings, has announced that Terry Rich has joined the company as president of Global Spine. In a press statement, RTI said that Rich brings decades of deep spine leadership and commercial success to the role. The company...
EOS imaging has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new generation imaging system, EOSedge. Receipt of FDA 510(k) clearance follows the commercial launch of EOSedge in Europe, Canada and Australia last week....
Results from the COAST-X trial show that patients treated with Taltz (ixekizumab, Eli Lilly and Company) achieved improvement in the signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSp). COAST-X is a multicentre, randomised, double-blind, placebo-controlled 52-week study evaluating the efficacy...
This advertorial has been sponsored by B. Braun Less is more–The increasing economic burden and complexity in hospital processes forces hospitals to map and improve their structures and processes and to increase the treatment quality and safety in patient care....
Highlights: Short segment TLIF can increase lordosis in fused segments Elective one to three level ACDFs at physician-owned hospitals cost less and have fewer complications Profile: Margareta Nordin Jeffrey Wang discusses the future direction for NASS AI-based classification may...
Highlights: Short segment TLIF can increase lordosis in fused segments Elective one to three level ACDFs at physician-owned hospitals cost less and have fewer complications Profile: Margareta Nordin Jeffrey Wang discusses the future direction for NASS AI-based classification may...
Procrustes analysis—a form of statistical shape analysis—could be used to predict postoperative results in advance of surgery for adolescent idiopathic scoliosis (AIS), a study presented by Adrian Gardner (Royal Orthopaedic Hospital, Birmingham, United Kingdom) at the British Scoliosis Society...
This advertorial has been sponsored by Aesculap Spine surgery is changing—the increasing demands on treatment concepts are making hospital processes more complex, and all departments are affected. Hospitals need more than just products—they need sustainable solutions that improve daily work...
Life Spine has received clearance from the US Food and Drug Administration (FDA) to market the Longbow titanium lateral expandable spacer system. The Longbow system is available in lengths ranging from 45–60mm, heights from 9mm–15mm, 0 degrees and 7 degrees...
NuVasive has received US Food and Drug Administration (FDA) 510(k) clearance for expanded indications for the CoRoent small interlock system. The expanded indication allows for on-label use of the device at multiple contiguous levels from C2-T1 for anterior cervical...
DePuy Synthes has launched the SYMPHONY Occipito-Cervico-Thoracic (OCT) System, expanding its offering for the surgical treatment of conditions in the neck and upper back. The SYMPHONY System includes a differentiated offering of instruments and implants designed for stabilisation of...
Three months of treatment with amoxicillin did not provide a clinically important benefit in patients with chronic low back pain and Modic changes, a study published in the British Medical Journal (BMJ) has concluded. The AIM study, a double...
Life Spine has announced the initial surgeries using the Centerline modular thoracolumbar spinal system. The Centerline modular thoracolumbar spinal system features low profile 4.75mm cobalt chrome rods designed to minimise impact to surrounding anatomy. The screw design offers a cortical...
Cerapedics today announced that the US Food and Drug Administration (FDA) has approved the company's premarket approval (PMA) supplement for i-FACTOR peptide enhanced bone graft in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc...
Astura Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Alta anterior cervical corpectomy spacer system. Available in either HA PEEK or acid-etched Ti surface options, the system provides four different axial footprints in...
Relevant patient comorbidities and surgical complications are associated with increased readmission within 90 days of elective revision lumbar fusion surgery, a retrospective study published in the Global Spine Journal has found. Readmission within 90 days is also linked to...
Novartis today announced detailed results from the randomised, double-blind, placebo-controlled phase III PREVENT study, evaluating the efficacy and safety of Cosentyx (secukinumab) in patients with non-radiographic axial spondyloarthritis. Axial spondyloarthritis is a spectrum of long-term inflammatory disease characterized by...

Tim Pigott

A consultant neurosurgeon and the current president of EUROSPINE, Tim Pigott talks to Spinal News International about his career so far. Outside of his daily practice and society engagements, he is also involved in research into how we can...
Spineology has announced that 24-month outcomes data from SCOUT clinical trial were presented by John Chi (Brigham and Women’s Hospital, Boston, USA), at the recent Society for Minimally Invasive Spine Surgery (SMISS) annual meeting (SMISS Annual Forum; 31 October–2...
  Nevro has received approval from the US Food and Drug Administration (FDA) for the Senza Omnia spinal cord stimulation system to treat chronic pain. The Omnia system is designed to deliver Nevro’s proprietary HF10 therapy in addition to other...
Spine technology company Astura Medical has announced the relocation of its corporate headquarters from Carlsbad, California to Irving, Texas. The move was effective November 4, 2019. The company’s new 40,000 square foot facility will provide an expanded framework to support...
Hierarchical clustering of patient data using artificial intelligence (AI) can identify patterns that may guide preoperative decision-making in adult spinal deformity (ASD) surgery by predicting outcomes and major complications, a collaborative study by the International Spine Study Group and...
Stryker has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Sahara Lateral 3D expandable interbody system. The product will be on display at the Society for Minimally Invasive Spine Surgery Annual Forum (SMISS; 31...
Spinal metastases patients with low serum albumin and elevated platelet-lymphocyte ratio (PLR) should be advised regarding the impact of these laboratory markers on outcomes, including survival, a recent study has found. Efforts should also be made to optimise nutrition...
A psychosocial behavioural intervention administered in the spine care setting was successful in increasing physical activity after recuperation from lumbar surgery, a trial has found. Carol A Mancuso (Hospital for Special Surgery, New York, USA) presented the findings of...
DiscGenics has announced that it has received the go-ahead from an independent data safety monitoring committee (DSMC) to enrol the final 24 patients in its first-in-human US clinical study of IDCT, an allogeneic, injectable disc cell therapy for mild...
Paul Sponseller, president of the Scoliosis Research Society (SRS) 2019–2020, talks to Spinal News International about the society's 54th annual meeting (18–21 September, Montreal, Canada), which attracted over 1,400 attendees from around the world. The conference began with a pre-course,...
The US Food and Drug Administration (FDA) has approved a new prospective, randomised clinical trial evaluating the use of recombinant human bone morphogenetic protein-2 (rhBMP-2, Infuse, Medtronic) during transforaminal lumbar interbody fusion (TLIF) procedures. The study is part of...
GTX Medical (formerly G-Therapeutics) and NeuroRecovery Technologies (NRT) have announced a merger to further the development of neuromodulation therapies to aid functional recovery of people with spinal cord injuries. The merged entity will be known as GTX medical BV....
Stryker has completed the acquisition of Mobius Imaging and its sister company, GYS Tech, which trades as Cardan Robotics. The acquisition was agreed in September as an all cash transaction of approximately US$370 million upfront and up to US$130 million...
Synchron recently announced the first successful implant of its minimally-invasive neural interface technology (Stentrode) as part of a trial evaluating the safety and efficacy of the technology for restoring communication in people with severe paralysis. The technology uses modular training...
Long-term results demonstrate that even though implantation of a stand-alone interspinous process device (IPD) can be successful in treating intermittent neurogenic claudication (INC), the high reoperation rate does not justify its use and simple decompression is more effective. This...
CarboFix has announced that the US Food and Drug Administration (FDA) has cleared its CarboClear Carbon Fiber Vertebral Body Replacement (VBR) System to replace a collapsed, damaged, or unstable vertebral body due to tumour or trauma. The CarboClear VBR System...
Researchers from The Johns Hopkins University School of Medicine (Baltimore, USA) performed a systematic review and meta-analysis of published data on the effect of electrical stimulation therapies on spinal fusion. They found significant improvement overall in the rates of...
Synaptive Medical will offer its robotic surgical microscope, Modus V, to the spine market as part of an expanded marketing agreement with Stryker. The company is also announcing a co-marketing collaboration with Stryker’s advanced guidance technologies business for the...
Redd Warburton, a senior executive search consultant specialising in orthopaedics and spine,  has been exploring how 3D printing has the potential to revolutionise the manufacture of spinal implants. Here is a summary of her findings. The full article, produced...
The results of a recent study suggest that elective one to three level anterior cervical discectomy with fusion surgeries (ACDFs) at physician-owned hospitals have significant cost savings, while having lower odds of experiencing 90-day medical complications and readmissions. These...
Early postoperative results of a double blind randomised clinical trial demonstrate the benefit of local intraoperative corticosteroids (LIC) delivered with an absorbable haemostatic matrix to prophylactically reduce dysphagia following anterior cervical discectomy and fusion (ACDF) surgery. The findings were...
According to new research, certain ratios of correction of cervical parameters contribute to improving neck disability. The study, authored by Katherine E Pierce (NYU Langone Medical Centre, New York, USA) and colleagues, was recently nominated for Best Paper at...
Brainlab has unveiled Loop-X, the first mobile intraoperative imaging robot, at NASS 2019 (34th Annual North American Spine Society Meeting; 25–28 September, Chicago, USA). Loop-X sits at the core of the Brainlab Digital Surgery portfolio for the rapidly evolving...
Medtronic today announced US Food and Drug Administration (FDA) approval of a prospective, randomised pivotal clinical trial for the use of Infuse bone graft in transforaminal lumbar interbody fusion (TLIF) spine procedures. "The potential to expand the indications for use...
Alphatec Holdings announced today the commercial release of its IdentiTi TLIF Posterior Oblique Titanium Interbody Implant System (IdentiTi PO) for transforaminal lumbar interbody fusion procedures. The launch of IdentiTi (TLIF) PO follows successful alpha evaluations that began in January 2019...
RTI Surgical will showcase its body of clinical data at the 34th Annual Meeting of the North American Spine Society Annual Meeting (NASS 2019; 25–28 September, Chicago, USA). “RTI is proud to not only be a partner of choice for...
The Johnson & Johnson Medical Devices Companies today announced that DePuy Synthes has launched the CONDUIT Interbody Platform with EIT Cellular Titanium Technology, further expanding its comprehensive offering to treat degenerative spine disease. The portfolio, which includes 3D printed...
ControlRad has announced the first clinical use of the ControlRad Trace system following its clearance by the US Food and Drug Administration. The initial procedures were performed at Niagara Falls Memorial Medical Center (Niagara Falls, USA) by Andrew Cappuccino,...
Highlights: Worldwide burnout survey "highlights the need for better interventional programmes" (p. 1) Intravenous ketorolac substantially reduces opioid use following lumbar spinal fusion (p. 1) Paul Sponseller, president elect of the Scoliosis Research Society, gives his highlights of IMAST...
AOSpine is the leading global academic spine community, creating, disseminating, and exchanging knowledge to promote excellence in patient care and outcomes. This supplement will explore what makes AOSpine unique as a spine society, and how it stays relevant for...
RTI Surgical has announced the first surgery using the HPS 2.0 Hybrid Performance System, a modular pedicle screw system used for mono- and multi-segmental rigid, hybrid or dynamic posterior stabilisation of the thoracolumbar spine. William Sears, a neurosurgeon and Fellow...
Fundamental Surgery has announced the expansion of their Global Medical Panel with Yousuf Khalifa, Ivan Wong, and Areena D’souza as their latest members. In their roles, they will they will provide scientific and clinical guidance in the development of...
For Lenke 1A curves between 45 and 65 degrees treated with low- versus high-implant density in adult idiopathic scoliosis (AIS) patients, a prospective, multicentre, randomised controlled study has shown equivalent percentage coronal curve correction. The Minimise implants maximise outcomes...
Medtronic has announced that the National Osteoporosis Foundation (NOF) supports the vertebral compression fracture (VCF) Care Pathway, a new evidence-based clinical care pathway developed by a multispecialty panel of experts to ensure osteoporotic VCF patients receive timely and...
Camber Spine has announced the launch of its first spinal implant designed and manufactured specifically for the oblique lumbar interbody fusion (OLIF) spine surgical procedure. This implant represents the fifth product in its distinctive, rapidly growing SPIRA device family....
Omar Ishrak, Medtronic’s chairman and CEO is to retire on 26 April 2020, following the end of the company’s current fiscal year. Also, the Medtronic Board of Directors has announced key leadership appointments as part of its multi-year, leadership...
A new study, published in the European Spine Journal, suggests that a computer-aided method has the potential for automatic Cobb angle measurement and scoliosis diagnosis on chest X-rays. As the Cobb angle is involved in therapeutic decisions of scoliosis,...
A meta-analysis, recently published in Osteoporosis International, has found that the application of percutaneous vertebroplasty (PVP) is safe and effective only in patients with acute osteoporotic vertebral compression fractures (OVCFs) having persistent and severe pain. The investigators recorded no...
Life Spine recently announced that it is now selling its Micro Invasive suite of products in thirty countries worldwide. New customers in Vietnam and South America have recently begun purchasing products from Life Spine’s broad product portfolio and Life Spine...
Nexxt Spine has released their Lordotic TLIF Oblique interbody into the market.  The product is designed for transforaminal lumbar interbody fusion (TLIF), the most frequently performed procedure in the field. Derived from the NEXXT MATRIXX family of products, Lordotic TLIF...
Bad posture among UK office employees is a nationwide epidemic. Sitting at desks all day, slouching over computers and a general sedentary lifestyle has led one in five Brits to give up their job or reduce hours because of...
DiscGenics has announced that the US Food and Drug Administration (FDA) has granted fast track designation for its investigational cell therapy, IDCT, currently being evaluated in regulator-allowed clinical trials in the USA and Japan for the reduction in pain...
According to a press release, SurGenTec has received FDA clearance for a neurostimulation indication for their ALARA Neuro Access Needle Kit. The ALARA system is used for targeting and assisting in cannulating a pedicle. Targeting needles are generally the...
The Congress of Neurological Surgeons (CNS) recently awarded their Top Paper of the Year and Spine Section Paper of the Year to an analysis of 10-year results from a prospective, randomised, clinical trial comparing cervical disc arthroplasty (CDA) to...
Zimmer Biomet recently announced US Food and Drug Administration (FDA) approval for The Tether for treatment of scoliosis, providing a fusion-less alternative for young patients requiring surgery. The current surgical treatment for scoliosis is an invasive operation involving large incisions, extensive soft...
Medtronic has completed its acquisition of Titan Spine, which has a range of interbody fusion devices that feature unique surface technology. A press release reports that the acquisition provides opportunities to bundle interbodies, screws, rods, biologics, and “enabling” technologies,...
A recent study developed models capable of “excellent discrimination” between operative and non-operative management of patients based solely on baseline preoperative values. According to the authors, patient-reported outcome measures (PROMs) were particularly instrumental in making these predictions, and they...
While robotic technology is still in its infancy, current evidence suggests a promising future for its application in spine surgery, argue Ronald A Lehman and Nathan J Lee. Here, for Spinal News International, they discuss the results of recent...
Spineology has announced the launch of the Duo Angled Instrumentation System. The angled instrumentation supplements the Duo Lumbar Interbody Fusion System and allows surgeons to efficiently address the L4–L5 disc space in cases where the iliac crest prevents collinear...
Bernhard Meyer (Munich, Germany) and Henry Halm (Neustadt, Germany) discuss spinal navigation—specifically any increased risk in radiation exposure and if that risk is offset by the potential benefit of an increase in precision of pedicle screw placement. The two physicians...
Alphatec Holdings announced today the commercial release of InVictus minimally invasive, or MIS, SingleStep K-wireless implant delivery system. By completely eliminating the requirement for K-wires in a percutaneous pedicle fixation procedure, SingleStep limits the potential complications associated with inadvertent...
DiscGenics today announced the first patients have been treated in its Japanese safety study, a clinical trial of IDCT for mild to moderate degenerative disc disease (DDD). The treatments took place at Tokai University School of Medicine in Kanagawa,...
The Medicrea Group announced today that it has received FDA clearance for Tulip Genesis, which completes its UNiD ASI platform technology. With the FDA clearance of the Tulip Genesis, Medicrea completes its UNiD ASI platform by providing a top loading...
President of the Scoliosis Research Society (SRS), Peter Newton (San Diego, USA), speaks to BLearning at IMAST 2019 (17 –20 July, Amsterdam, The Netherlands) about this year’s annual meeting, which “focused on innovation” and covered the “breadth of spinal surgery, not just spinal deformity...
Fernando Techy (Johnstown, USA), speaks to BLearning at IMAST 2019 (17–20 July, Amsterdam, The Netherlands) about longer-term trials of disc replacement which, according to Techy, has shown that “we are having less re-operations with disc replacement compared to fusion” and that “disk...
Paul Sponseller, president elect of the Scoliosis Research Society (SRS), talks to Spinal News International about the 26th International Meeting on Advanced Spine Techniques (IMAST 2019; 17–20 July, Amsterdam, The Netherlands). The mission of IMAST was to complement the...
Orthofix Medical recently announced that it has named Jon Serbousek as president of its Global Spine business effective 5 August, 2019, and the successor to Brad Mason, the company’s retiring president and chief executive officer (CEO), to be effective...
SeaSpine has announced the limited commercial launch of the Mariner Outrigger Revision System. Mariner Outrigger is an implant system providing surgeons a high level of versatility for multiple revision applications. As an adjunct to the Mariner Posterior Fixation system, Mariner...
In a recent, award-winning study, 266 million individuals worldwide (3.63%) were found to have degenerative spine disease and low back pain annually. “Significantly,” the investigators note, “data quality is higher in high-income countries, making overall quantification in low- and...
Kenneth Cheung (Hong Kong) speaks to BLearning at IMAST 2019 (17 –20 July, Amsterdam) about how growth modulation techniques can be used to treat spinal deformity in young children. Traditionally, spinal deformity has been corrected using spinal fusion. However,...
The presence of a sleep disorder has a "significant and unique effect" on back pain-related healthcare use—beyond the impact of pain intensity, disability, and other factors, according to a study recently published in Spine. Authors Daniel Rhon (Brooke Army...
The results of a recent study indicate that anterior column realignment (ACR) via a lateral approach allows for the normalisation of spinopelvic parameters without additive complication risk when compared to lateral lumbar interbody fusion (LLIF). Presenting author Praveen Mummaneni...
Early results of a double-blind, randomised, placebo-controlled trial show that intravenous ketorolac results in a “substantial reduction” in opioid use and improved pain control compared to placebo and intravenous acetaminophen. In addition, the investigators note a trend towards decreased...
Implanet has announced that its Jazz Lock technology, which is an integral part of its Jazz solutions platform, has been granted a patent in the USA. A major component of the broadest range of band products on the market, Jazz...
Life Spine announced today that the US Food and Drug Administration (FDA) has provided additional 510(k) market clearance for the ProLift expandable spacer system. “The new 8–10mm widths of the ProLift expandable spacer system are essential additions to our innovative...
Alphatec Holdings has announced the commercial release of InVictus, a spinal fixation platform designed to address a range of pathologies through a minimally invasive (MIS), open, or hybrid surgical approach. “The InVictus platform incorporates and improves upon the learnings...
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