Jamie Bell
Proprio announces strategic partnership with Biedermann to “revolutionise” spine surgery
Proprio has announced a “landmark” multi-phase partnership with the Biedermann Group—an innovator in next-generation spinal implant systems and procedural solutions. Initially, the companies will...
From new technologies to market shifts—the future landscape of spinal surgery
A Spinal News International guest article sees Arthur L Jenkins III (New York, USA) outline what he perceives as the current, and indeed future,...
SpineX closes recruitment for trial evaluating Scone SCS technology in neurogenic...
SpineX has closed recruitment for the CONTINENCE clinical trial of its proprietary Scone device. The study began back in May 2022 and is evaluating...
Orthobond secures US FDA nod for antibacterial surface treatment applied to...
Orthobond Corporation has announced that the US Food and Drug Administration (FDA) recently granted its de novo marketing request for the use of Ostaguard—its...
Medcura closes US$22.4 million in financing to boost surgical haemostasis portfolio
Medcura has announced that it has closed a private placement with aggregate gross proceeds of US$22.4 million in convertible debt. The company intends to use the...
HIG Capital acquires ZimVie’s Spine business, now rebranded as Highridge Medical
HIG Capital has announced that one of its affiliates has completed the acquisition of the Spine division of ZimVie, with the acquired business set...
PainTEQ highlights SECURE data showing efficacy and safety of LinQ implant
Final data from a “landmark” study on a posterior-approach sacroiliac (SI) joint fusion with PainTEQ's LinQ implant have revealed improved pain and function scores—and...
PathKeeper enters into agreement with Mayo Clinic for low-radiation paediatric spine...
PathKeeper Surgical has announced that it has entered into a know-how agreement with Mayo Clinic to research radiation levels in paediatric spine surgeries. The...
Spineart secures CHF20 million funding following completed enrolment in IDE trials
Spineart has announced that it has successfully raised CHF20 million in convertible financing—an announcement that follows the completion of enrolment in the company’s two BAGUERA C...
Nevro receives US FDA 510(k) clearance to use SI fixation system...
Nevro Corporation has announced that the US Food and Drug Administration (FDA) has cleared its sacroiliac (SI) joint fusion device, which will be marketed...
Woven Orthopedic secures US FDA 510(k) clearance for larger version of...
Woven Orthopedic Technologies has received its second 510(k) clearance from the US Food and Drug Administration (FDA) for the use of the Ogmend implant enhancement...
Onward Medical awarded US FDA Breakthrough Device designation for ARC-BCI system
Onward Medical announced recently that it has been awarded Breakthrough Device designation (BDD) by the US Food and Drug Administration (FDA) for the ARC-BCI...
Nanomedicine may help deliver targeted therapy for spinal cord injury
Researchers in Italy have demonstrated that an innovative nanovector (nanogel)—which they developed—is able to deliver anti-inflammatory drugs in a targeted manner into glial cells actively involved...
“World-first” spine reconstruction surgeries achieved using Apple Vision Pro
Exex, along with neurosurgeon Robert Masson (Masson Spine Institute, Orlando, USA), has achieved what the company claims is a “world-first” by bringing the Apple...
Theradaptive secures US FDA approval to begin enrolment in Phase I/II...
Theradaptive has gained approval from the US Food and Drug Administration (FDA) for its investigational device exemption (IDE) submission to begin enrolling patients into...
Boston’s WaveWriter SCS systems gain expanded non-surgical back pain indication from...
Boston Scientific Corporation announced today that the US Food and Drug Administration (FDA) has approved an expanded indication of the company’s WaveWriter spinal cord...
Study indicates benefits of switching from microscope to 3D exoscope in...
Researchers and neurosurgeons at the Medical University of South Carolina (MUSC; Charleston, USA) retrospectively compared the operative microscope to the 3D exoscope in a...
Medtronic announces trial data on closed-loop and DTM SCS therapies at...
At this year’s North American Neuromodulation Society (NANS) annual meeting (18–21 January, Las Vegas, USA), Medtronic announced new data from two clinical trials demonstrating...
Boston Scientific announces positive WaveWriter SCS findings from SOLIS trial
Boston Scientific Corporation has announced positive one-year results from the SOLIS randomised controlled trial, demonstrating sustained pain relief using its WaveWriter Alpha spinal cord...
Nevro to highlight 25 scientific abstracts on spinal cord stimulation at...
Nevro Corporation has announced a series of data presentations supporting the use of the company's high-frequency (HFX) 10kHz spinal cord stimulation (SCS) therapy for...
Saluda announces plans to present new EVOKE study data at NANS...
Saluda Medical has announced that its data will be presented at the upcoming North American Neuromodulation Society (NANS) annual meeting (18–21 January, Las Vegas,...
3Spine announces completion of US FDA clinical trial enrolment
3Spine has announced the achievement of completed US clinical trial enrolment, with 151 completed MOTUS lumbar total joint replacement surgeries and 174 real-world posterior...
SynerFuse appoints Rohan Lall as chief medical officer
SynerFuse has announced the appointment of Rohan Lall (M Health Fairview Neurosurgery, Princeton, USA) as the company’s chief medical officer. The appointment was effective...
Cerapedics files final module of PMA application for new P-15 peptide...
Cerapedics has today announced that it has filed the final module in a premarket approval (PMA) application with the US Food and Drug Administration...
Washington state “poised” to extend spinal cord stimulation coverage following straw...
As per a recent statement from the North American Neuromodulation Society (NANS), the US state of Washington may be about to extend its insurance...
ZimVie announces compatibility between Vital spinal fixation system and Brainlab’s Spine...
ZimVie recently announced it has received US Food and Drug Administration (FDA) clearance for its Vital spinal fixation system including instruments for use with...
Providence publishes 91% revision success rate in failed ACDF patients
Providence Medical Technology has announced a new publication in the Journal of Clinical Neuroscience in which Michael Haglund (Duke University Medical Center, Durham, USA) and colleagues...
SpineX close to full recruitment for SCONE clinical trial
SpineX has announced that it is close to full recruitment of the patient cohort for a clinical trial of its proprietary SCONE device, recently...
Spineway announces international rollout of VEOS range including first implants in...
The Spineway Group has announced the accelerated rollout of its range of VEOS implants for intervertebral fixation by posterior approach into new markets.
This technology—which...
Variability in early surgery for acute cervical spinal cord injury patients
Following their recent publication in the Journal of Neurotrauma—which identified variability across acute cervical spinal cord injury (SCI) patients undergoing early surgery—several study authors...
Nevro announces acquisition of Vyrsa Technologies
Nevro Corporation has announced that it has acquired Vyrsa Technologies—a privately held medical technology company focused on a minimally invasive treatment option for patients...
PathKeeper heralds first spine surgery performed with company’s 3D optical navigation...
PathKeeper Surgical has announced the first use of the PathKeeper 3D optical navigation system during a spinal fusion surgery at Southcoast Health's St Luke's...
Nalu announces positive results from spinal cord stimulation nPower US clinical...
Nalu Medical has announced the publication of the spinal cord stimulation (SCS) nPower US clinical study in the Pain Physician Journal, reporting on clinical outcomes...
CTL Amedica’s Monet ACIF system approved for use in Mexico
The Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)—the agency that oversees the quality of medical devices made in and imported into Mexico—has...
Death rates after spinal fusion and other surgeries “similar” regardless of...
Death rates after major surgery are similar regardless of whether a male or female surgeon operates on a male or female patient, a large...
Nevro announces “profound improvements” in non-surgical refractory back pain patients treated...
Nevro Corporation has announced the publication of new 24-month data from the SENZA-NSRBP multicentre randomised controlled trial (RCT) in the Journal of Neurosurgery: Spine. The...
Boston Scientific expands neuromodulation portfolio with Relievant Medsystems acquisition
Boston Scientific Corporation has announced the close of its acquisition of Relievant Medsystems—the company behind the US Food and Drug Administration (FDA)-cleared Intracept intraosseous...
SpineX announces new report on SCS improving bladder function in stroke...
SpineX has reported in a press release that a publication titled, “A pilot study of the effect of transcutaneous spinal cord stimulation on micturition-related...
Medical necessity “should drive all remote monitoring decisions” in SCS, expert...
The principle of medical necessity “should drive all remote monitoring decisions” relating to spinal cord stimulation (SCS) technologies, according to recommendations recently published in...
ZimVie announces first US surgery with 4.5mm Mobi-C cervical disc
ZimVie has announced that the first patient in the USA has received its newly approved 4.5mm Mobi-C cervical disc device.
Introduced in France in 2004,...
Ulrich announces full US commercial launch of Momentum MIS posterior spinal...
Ulrich Medical USA has announced the full US commercial launch of the Momentum MIS posterior spinal fixation system at the 2023 North American Spine Society (NASS)...
Mirus announces US FDA 510(k) clearance for MoRe low-profile plating systems
Mirus has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its CYGNUS MoRe anterior cervical plate (ACP) and...
NovApproach launches OneLIF interbody fusion device at NASS 2023
NovApproach Spine recently announced the full market launch of its patented OneLIF interbody spinal fusion system, which supports “a multitude of surgical approaches”, during...
Silony Medical completes acquisition of Centinel Spine’s Global Fusion Business
Silony Medical has announced that it has completed the acquisition of Centinel Spine's Global Fusion Business and related assets.
The completed transaction includes all of...
Zoher Ghogawala named president of North American Spine Society
Zoher Ghogawala (Lahey Hospital and Medical Center, Burlington, USA) was named president of the North American Spine Society (NASS) during the society’s recent 38th...
Cerapedics announces long-term data from pivotal study of i-FACTOR bone graft
Cerapedics has announced long-term follow-up data from its pivotal investigational device exemption (IDE) study of the i-FACTOR peptide-enhanced bone graft. Published data demonstrate fusion...
SynerFuse completes enrolment in proof-of-concept study
SynerFuse has announced that it has completed enrolment in its proof-of-concept study to evaluate the safety and tolerability of the Electric Transforaminal Lumbar Interbody...
Intraoperative imaging and AI in spinal deformity surgery: opportunity awaits
In a guest piece for Spinal News International, Tommy Carls (Memphis, USA) outlines the potential offered by the continued growth of intraoperative imaging and...
Joimax launches new iLESSYS biportal interlaminar endoscopic surgical system
Joimax has launched its new iLESSYS biportal interlaminar endoscopic surgical system for the treatment of spinal disorders at the recent EUROSPINE 2023 (4–6 October, Frankfurt,...
Stryker announces more than 2,400 spinal cases in first year with...
Stryker has announced that its Q guidance system with spine guidance software has been used to deliver enhanced surgical planning and navigation in more...
Boston receives expanded US FDA approval of SCS therapy for painful...
Boston Scientific has announced that the US Food and Drug Administration (FDA) has approved an expanded indication of the WaveWriter Alpha spinal cord stimulator...
Retrospective study finds decreasing rate of spinal immobilisation treatment in prehospital...
A study analysing the practice of spinal motion restriction (SMR) between 2009 and 2019 has been published in a recent issue of the journal Academic...
Vuze Medical to showcase second-generation MISS system at NASS 2023 following...
Vuze Medical has submitted a 510(k) filing with the US Food and Drug Administration (FDA) for VUZE 2.0—a new, second-generation, investigational version of its...
Biotronik announces new data supporting effectiveness of RESONANCE multiphase stimulation paradigm
Biotronik Neuro has announced that results from the BENEFIT-02 trial—the “first of its kind” to clinically evaluate a multiphase stimulation paradigm—support the effectiveness of...
NANS leads multi-society response to “methodologically flawed” SCS re-review in Washington...
The North American Neuromodulation Society (NANS) has led a multi-society response to the Washington State Health Care Authority (WSHCA) following its review of the...
4WEB Medical receives 510(k) clearance to market new integrated cervical plate
4WEB Medical has announced that it has received 510(k) clearance to market the newest additions to the company's implant portfolio—the Cervical Spine Truss System...
Carlsmed gains US FDA Breakthrough Device designation for Aprevo technology
Carlsmed recently announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for Aprevo—a technology used in the treatment of...
Saluda receives US FDA approval for MRI labelling of Evoke spinal...
Saluda Medical has announced that the US Food and Drug Administration (FDA) has approved magnetic resonance imaging (MRI) conditional labelling for its Evoke system,...
Onward announces first-in-human implant of ARC-IM stimulator with wireless BCI device
Onward Medical has today announced the successful first-in-human implant of its ARC-IM stimulator intended to restore upper-extremity function after spinal cord injury (SCI). The...
ChoiceSpine announces standalone indication for Blackhawk Ti 3D-printed cervical spacer system
ChoiceSpine recently announced that it has received clearance from the US Food and Drug Administration (FDA) to market the Blackhawk Ti 3D-printed cervical spacer system...
SpineGuard announces presentation of data indicating 100% success rate with DSG...
SpineGuard has announced that a research team presented an article at the 2023 Conference on New Technologies for Computer and Robot Assisted Surgery (CRAS;...
Nevro announces new data demonstrating health economic benefits of 10kHz SCS...
Nevro Corporation has announced the publication of new data validating the health economic benefits of 10kHz therapy, the company’s proprietary, high-frequency spinal cord stimulation...
Boston Scientific to expand neuromodulation portfolio with Relievant Medsystems acquisition
Boston Scientific Corporation has today announced it has entered into a definitive agreement to acquire Relievant Medsystems—a privately held medical technology company that has...
Studies indicate workers’ compensation patients fare worse than counterparts following lumbar...
Two studies recently published in the peer-reviewed Journal of Neurosurgery: Spine have found that workers’ compensation patients undergoing lumbar spine surgery fare worse post-surgery than...
Astura announces initial case and full commercial release for El Capitan...
Astura Medical has announced the full commercial release and first case with its most recent expandable technology, the El Capitan X expandable anterior lumbar...
Informed consent is a critical process for patients and physicians alike...
Even though obtaining informed consent is an important procedure before spinal surgery, almost 40% of the patients in a recent study—published in the European...
Medtronic receives CE-mark approval for Inceptiv closed-loop SCS to treat chronic...
Medtronic has received CE-mark approval for its Inceptiv closed-loop rechargeable spinal cord stimulator in the treatment of chronic pain.
Inceptiv is the first Medtronic spinal...
Wenzel Spine receives US FDA clearance expanding clinical indications for primaLOK...
Wenzel Spine has gained US Food and Drug Administration (FDA) clearance for its primaLOK SP system—marking a "significant advancement in spinal fusion technology", offering...
Viseon announces commercial rollout, initial clinical use of 4K MaxView system
Viseon has announced the US commercial rollout and initial clinical use of a “first-of-its-kind” 4K advanced visualisation system for minimally invasive spine surgery. The...
Health economic data show cost-dominance of Saluda’s EVOKE system over open-loop...
Saluda Medical has announced the publication of new health economic data in the Clinical Journal of Pain that provides “the strongest ever economic case” for the...
‘Intelligent suit’ supported by AI and electrical stimulation could enhance spinal...
Experts in Germany are working on an ‘intelligent suit’ with which they hope to significantly improve rehabilitation after a serious spinal cord injury. This...
Education and collaboration key to continued advancement of painful diabetic neuropathy...
The neuromodulation space has proliferated significantly over the past few years, and one area in which this is most notable is with the expansion...
NeuroSolv seeks to expand development and approval of novel spinal cord...
In partnership with AscellaHealth, NeuroSolv Therapeutics is seeking to expand the clinical trial development programme and accelerate regulatory approval procedures to optimise the prospect...
Stryker announces commercial launch of Q guidance system with cranial guidance...
Stryker has commercially launched its Q guidance system with cranial guidance software to provide surgeons with an image-based planning and intraoperative guidance system that assists...
First SynerFuse procedure performed by solo surgeon in two-level spinal fusion...
SynerFuse has announced that—for the first time in the world, it claims—a solo spine surgeon has performed the SynerFuse procedure in a two-level spinal...
Cochrane Library urged to retract and revise recent SCS review over...
Pain physicians have urged the Cochrane Library to retract and revise a recent review of spinal cord stimulation (SCS) in the treatment of low...
Brain-computer interface plus SCS therapy enables thought-controlled walking after spinal cord...
Onward Medical has announced a recent publication in Nature showing that a wireless brain-computer interface (BCI) can use patients’ thoughts to modulate ARC therapy....
Abbott gains US FDA nod to treat non-surgical back pain with...
Abbott has announced that the US Food and Drug Administration (FDA) has approved its spinal cord stimulation (SCS) devices for the treatment of chronic...
The new standard for SCS therapy—neural activation measurement, targeting and maintenance
Jason Pope (Santa Rosa, USA) discusses closed-loop spinal cord stimulation (SCS) and its potential to provide sustained, holistic outcomes for chronic pain patients. In...
SynerFuse announces presentation of IDE proof-of-concept study data
SynerFuse has announced that Michael Park (University of Minnesota, Minneapolis, USA)—principal investigator for the company’s investigational device exemption (IDE) proof-of-concept study—presented data from the study’s...
Biotronik announces US FDA approval of Prospera spinal cord stimulation system
Biotronik has announced US Food and Drug Administration (FDA) approval for Prospera—a new spinal cord stimulation (SCS) system. The system features RESONANCE, which the...
Review concludes SCS benefits do not outweigh associated risks and costs...
A recently published Cochrane review has concluded that the clinical benefits of spinal cord stimulation (SCS) do not outweigh the risks and costs associated...
NeuroOne completes initial animal implant of thin-film paddle lead for spinal...
NeuroOne Medical Technologies has announced the successful completion of an initial animal implant of its novel, thin-film paddle leads for spinal cord stimulation (SCS)....
UK MHRA awarded £10 million to fast-track patient access to medical...
A total of £10 million has been awarded to the Medicines and Healthcare products Regulatory Agency (MHRA)—an executive agency of the UK Department of...
High-frequency spinal cord stimulation may be associated with “significant decrease” in...
High-frequency spinal cord stimulation (HF-SCS) for treating chronic refractory low back pain (CRLBP) may be associated with a significant decrease in total healthcare costs,...
Nevro announces full US market launch of HFX iQ spinal cord...
Nevro Corporation announced today that it has now initiated the full US market launch of its HFX iQ spinal cord stimulation (SCS) system, following...
Spinal cord stimulation found to “instantly improve” post-stroke arm and hand...
Spinal cord stimulation (SCS) therapy has been shown to trigger instant improvements in arm and hand mobility, enabling people affected by moderate-to-severe stroke to...
SCS therapies can play a role in cancer-related pain treatment despite...
Spinal cord stimulation (SCS) therapies targeting the dorsal column “may be considered” within the multimodal treatment plans typically required by cancer patients, but it...
Boston Scientific announces three-month data from SOLIS trial at NANS
Combination spinal cord stimulation (SCS) therapy with Boston Scientific’s WaveWriter system has demonstrated superior outcomes to conventional medical management (CMM) in chronic pain patients...
Abbott presents new data on streamlining patient-reported measures, BurstDR and more...
Abbott presented new data in more than 30 presentations and posters at the North American Neuromodulation Society (NANS) annual meeting (12–15 January 2023, Las...
Saluda Medical announces presentation of 36-month EVOKE trial data at NANS...
Saluda Medical has announced that late-breaking data from the "landmark" EVOKE clinical trial was presented at the recent North American Neuromodulation Society (NANS) annual...
SynerFuse announces “milestone” solo spine surgeon procedure in DRG stimulation study
Justin Zenanko, the CEO of SynerFuse, has announced that—in what the company says is a world-first—a solo spine surgeon has performed the “groundbreaking” SynerFuse...
Swiss parliament votes to accept US FDA-approved medical devices
The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation in Switzerland.
A motion...
Nevro announces US FDA approval of HFX iQ system to personalise...
Nevro Corporation has announced that it has received approval from the US Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS)...
Onward reports positive study results in restoring arm and hand function...
Onward Medical recently announced that the Up-LIFT pivotal study evaluating its non-invasive spinal cord stimulation (SCS) ARC-EX therapy achieved its primary effectiveness endpoint of...
Gimer Medical granted IDE approval for spinal cord stimulation system
Gimer Medical today announced that the company’s spinal cord stimulation (SCS) system was granted conditional investigational device exemption (IDE) approval by US Food and...
Abbott gains US FDA approval for Proclaim Plus spinal cord stimulation...
Abbott has announced that the US Food and Drug Administration (FDA) has approved its new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360...
Saluda Medical presents data on 24-month holistic response to spinal cord...
Saluda Medical has announced that Steven Falowski (Argires-Marotti Neurosurgical Associates of Lancaster, Lancaster, USA) recently presented late-breaking 24-month data from the company’s EVOKE study at...
High-frequency SCS demonstrates “substantial improvement” in health-related quality of life outcomes
Nevro Corporation has announced that the complete 12-month results from the SENZA-PDN randomised controlled trial (RCT), including health-related quality of life outcomes in patients with...
High responder rates, substantial pain relief and no explants among key...
Nevro Corporation has announced the results from data presentations at the American Diabetes Association (ADA) 82nd Scientific Sessions (3–7 June 2022, New Orleans, USA) supporting the use of...
Medtronic names Laura Mauri as new chief scientific, medical and regulatory...
Medtronic has announced that Laura Mauri has been appointed as the company’s chief scientific, medical and regulatory officer. This appointment adds to Mauri's prior responsibilities...
High-frequency SCS drives impactful outcomes for non-surgical refractory back pain patients
Following the recent introduction of key data supporting the use of high-frequency spinal cord stimulation (SCS) in the treatment of non-surgical refractory back pain...
Multiple-modality spinal cord stimulation demonstrates sustained improvement in chronic pain outcomes
A spinal cord stimulation (SCS) system capable of simultaneously delivering multiple treatment modalities has produced a sustained improvement in outcomes in a randomised controlled...
Nevro announces publication of 12-month data on high-frequency SCS for non-surgical...
Nevro Corporation has announced online publication of 12-month data from the SENZA-NSRBP randomised controlled trial (RCT) in Journal of Neurosurgery: Spine. These data show that...
Updated medical policy expands patient access to Abbott’s DRG stimulation technology
Abbott announced today that UnitedHealthcare (UHC)—the largest private health insurance company in the USA—has updated its ‘Implanted electrical stimulator for spinal cord’ medical policy...
FDA issues two final guidances for including patient perspectives in medical...
The US Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies.
As...
Nevro announces clinical data reinforcing significant and durable benefits of 10kHz...
Nevro Corporation has announced the results from data presentations at the 25th North American Neuromodulation Society (NANS) annual meeting (13–15 January 2022; Orlando, USA) supporting...
Current gaps and barriers in patient access to spinal cord stimulation
Maricela Schnur (St Luke’s Hospital, Duluth, USA) highlights a handful of socioeconomic disparities, racial differences, and psychological and psychiatric factors that currently present difficulties...
High-frequency SCS takes the stage to relieve chronic pain from diabetic...
Following the recent approval of the Senza system (Nevro) by the US Food and Drug Administration (FDA), Erika A Petersen (Little Rock, USA) discusses the...
Nevro announces FDA approval of high-frequency SCS therapy for painful diabetic...
Nevro has announced receipt of US Food and Drug Administration (FDA) approval for its Senza system to treat chronic pain associated with painful diabetic...
TheraCell announces first surgical uses of TheraFuze DBF Fiber Bag for...
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...
NuVasive’s Simplify Disc gains FDA approval for use in two-level cTDR
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)...