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UK MHRA adds capacity for medical device certification

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new approved bodies to increase the country’s capacity to certify medical devices. TÜV...

Ilika and Cirtec Medical partner on the manufacture and commercialisation of...

Ilika and Cirtec Medical have announced that they have signed a 10-year manufacturing licence to produce the Stereax range of mm-scale batteries at Cirtec’s...

US FDA seeks to “modernise” clinical trials with new draft guidance

The US Food and Drug Administration (FDA) has released draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernising the design...

Amazon executive joins Medtronic to spearhead development in robotics and implantables

Medtronic has announced that Ken Washington has been appointed chief technology and innovation officer. Washington joins Medtronic from Amazon where he served as vice president...

EU ministers approve changes to MDR transition timetable

The European Union’s Council of Ministers has today adopted a resolution to extend the deadline for the certification of medical devices under the Medical...

EU Commission to propose delay to MDR implementation

Europe’s health commissioner, Stella Kyriakides, has announced that proposals to extend the transition period for the implementation of the European Union’s (EU) Medical Device...

Medtronic expands reach of AI-powered surgical video management and analytics platform

Medtronic has announced that it has entered into a contract with Vizient to add Touch Surgery Enterprise, an AI-powered surgical video management and analytics...

Medtronic announces 2045 net zero emissions ambition to combat climate change

Medtronic has announced its ambition to achieve net zero carbon emissions by fiscal year 2045 across its operations and value chain to accelerate efforts...

Nuvasive to release VR training for lateral single-position spinal surgery

Nuvasive has announced the release of a virtual reality (VR) training module for the NuVasive X360 system to complement its Clinical Professional Development (CPD)...

Centinel Spine announces first international use of 3D-printed porous titanium FLX...

Centinel Spine has announced the first international implantation of the 3D-printed porous titanium FLX platform. Alfredo Guiroy and Jose Ricardo Prina in Argentina were...

i-FACTOR peptide enhanced bone graft is cost-effective compared to local autograft...

Cerapedics
Cerapedics has announced the publication of the results of a study to evaluate the cost-effectiveness of i-FACTOR peptide enhanced bone graft compared to autograft...

NuVasive launches Modulus ALIF 3D-printed porous titanium implant for anterior spinal...

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...

ADVERTORIAL: ESP disc replacement—favouring bone on-growth since 2004

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...

Medical Devices Regulation comes into effect across the EU

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...

ControlRad Select imaging system gains FDA market clearance

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...

Medtronic launches Adaptix interbody system in USA

Medtronic has announced the US launch of Adaptix interbody system, the first navigated titanium implant with Titan nanoLOCK surface technology, a proprietary blend of...

Study findings add to evidence for NuVasive’s MaXcess retractor

MaXcess retractor
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...

Study spotlights fall in Medicare reimbursement for orthopaedic trauma surgery

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...

Nexxt Spine launches cervical turn lock system

Nexxt Spine has announced the next generation of its standalone cervical system with the launch of Stand Alone Cervical Turn Lock (TL). The recently...

Cerapedics announces Canadian approval of i-FACTOR+ Matrix

cerapedics
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...

Wenzel Spine announces acquisition of Statera Spine

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...

DisGenics raises US$50 million in Series C funding round

idct
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,...

Researchers develop new classification system for adult idiopathic scoliosis

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...

Atlas Spine announces launch of its HiJAK SA expandable cervical standalone...

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...

Topical steroids reduce swallowing difficulties following ACDF surgery

Wellness
A study presented as part of the AAOS 2020 Virtual Education Experience has found that topical steroids administered during anterior cervical discectomy and fusion...

7D surgical gains CE mark approval for its MvIGS imaging system...

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...

Cerapedics announces IDE supplement for ASPIRE clinical trial

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...

Medtronic agrees Medicrea acquisition

Medicrea UNiD Hub
Medtronic has entered into a tender offer agreement for the acquisition of all outstanding shares of Medicrea, a developer of artificial intelligence software, predictive...

Learning curve in robot-assisted spinal fusion may be associated with inferior...

The use of robots to assist in spinal surgery carries a higher complication burden in the introductory phase as surgeons overcome the learning curve...

ulrich medical announces US release of the Momentum posterior spinal fixation...

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,...

IMAST 2020 reaches a digital audience

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,...

Intrathecal morphine reduces cost and lowers opioid requirement in scoliosis surgery

Using intrathecal morphine following surgical treatment of adolescent idiopathic scoliosis patients reduces hospital costs, yields better postoperative pain control and results in a significantly...

Initial data from LimiFlex IDE trial presented at IMAST 2020

Initial results of a US Investigational Device Exemption (IDE) trial studying use of a novel paraspinous tension band (LimiFlex, Empirical Spine) for the treatment...

Reducing pain at discharge may reduce opioid consumption in orthopaedic patients

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...

First EOSedge imaging platform installed in Germany

EOS imaging has announced the first installation of its EOSedge platform in Germany at the Asklepios Clinic St Georg in Hamburg. This follows the...

Study provides insight into adult cervical deformity surgery complications

Findings of a multicentre, prospective study conducted through the International Spine Study Group (ISSG) and presented at the 27th Annual Meeting on Advanced Spine...

Spinal Elements receives US FDA approval for Sapphire X device

Spinal Elements has announced US Food and Drug Administration (FDA) clearance of the Sapphire X device for anterior cervical fixation. Sapphire X is the...

Strategies for peri-surgical opioid management in spinal surgery patients

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...

NASS cancels 2020 meeting and moves to digital platform

NASS Annual Meeting Exhibition
The North American Spine Society (NASS) has cancelled its 35th Annual Meeting, which had been due to take place in San Diego, USA, between...

SeaSpine announces full commercial launch of Mariner MIS and Outrigger spinal...

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...

Undisclosed conflict of interest is “prevalent” in spine journals

Many studies published in major spinal surgery journals do not include the full disclosure of researchers’ financial conflicts of interest (COIs), according to a...

CoreLink launches F3D-C2 standalone cervical system

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...

Orthofix announces FDA clearance for Firebird SI fusion system

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...

“No statistical difference in outcomes” for minimally invasive lumbar decompression or...

Patient-reported functional outcomes vary considerably after lumbar spinal fusion surgery
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...

SeaSpine launches Northstar OCT and Cervical Facet Fusion systems

SeaSpine has announced the limited commercial launches and completion of initial surgeries of both its NorthStar OCT and Cervical Facet Fusion systems, expanding its...

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....

Meta-analysis finds higher rate of accuracy in robotic pedicle screw placement

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...

NuVasive launches Reline 3D for paediatric spinal deformity

NuVasive has today announced the expansion of its complex spine portfolio with the global commercial availability of Reline 3D, a posterior fixation system for...

Sirakoss receives US FDA clearance for Osteo3 ZP Putty

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)...

Paper details strategies for coping with psychological impact of spine care...

An editorial published in The Spine Journal details a series of strategies to mitigate the mental health impact of the provision of spine care...

SRS 2020 annual meeting moves to virtual format

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,...

Johns Hopkins surgeons perform spinal fusion using xvision augmented reality guidance

Augmented reality
Augmedics has announced that its xvision Spine System (XVS), augmented reality guidance system has been successfully used for the first time in a spinal...

ApiFix scoliosis correction system begins initial US launch

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...

MiRus announces first clinical use of the 3DR printed lumbar interbody...

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...

FDA clearance for 4WEB’s ASTS-SA lumbar interbody fusion device

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...

Relievant announces publication of Level I SMART study data

intracept
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...

Study suggests augmented reality could be widely applied in spinal surgery

Brainlab Elements Spine
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...

Spinal News International Issue 55 – May 2020 EU Edition

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...

Spinal News International Issue 55 – May 2020 US Edition

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...

Pedicle screw handling techniques “lead to contamination of screws”

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...

SpineGuard seeks US regulatory approval for DSG Connect platform

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)...

Meditech Spine receives FDA clearance for CURE Opel lumbar plate system

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...

Eurospine 2020 to be held as a virtual event

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...

Nexxt Spine receives US FDA 510(k) clearance for ALIF and lateral...

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...

Centinel Spine announces approval for the manufacturing transfer of prodisc technology

Centinel Spine has announced US Food and Drug Administration (FDA) approval for the manufacturing transfer of both the prodisc C Cervical Total Disc Replacement...

Is there a bright future for endoscopic spinal surgery?

Yingda Li and Michael Wang consider the increasing interest in endoscopic techniques in spinal surgery. The authors describe how endoscopic techniques have been incorporated...

COVID-19: Spinal surgeons report “elevated anxiety and uncertainty for the future”

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...

i-FACTOR clinical results show higher fusion rate compared to allograft

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...

Education in spine care during COVID-19

Jonathan Rasouli (Cleveland Clinic, Cleveland, USA) details discussions at the Virtual Global Spine Conference (May 5), which hosted key opinion leaders to discuss the...

Neo Medical closes US$13.4 million financing round

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...

Precision Spine announces US launch of Slimplicity anterior cervical plating system

Precision Spine has launched the Slimplicity HP anterior cervical plating (ACP) system in the USA, which has been designed to enable surgeons to accommodate...

US FDA approval granted for two Camber Spine devices

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...

NuVasive expands Advanced Materials Science implant portfolio

NuVasive has announced the expansion of its Advanced Materials Science (AMS) implant portfolio with the commercial launch of the Modulus XLIF dual sided plate,...

Telemedicine “essential for maintaining spine care” during COVID-19

A study of the use of virtual visits for paediatric spinal deformity patients suggests that telemedicine can provide faster care for patients, with comparable...

Astura Medical gains US FDA clearance for El Capitan ALIF system

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...

Study supports use of VIA Disc to treat degenerative disc disease

VIVEX Biologics has announced that the initial clinical trial results of the VAST Trial evaluating VIA Disc were published in The International Journal of...

How will technology shape spinal surgery during the next decade?

The last decade proved to be a turning point in the use of advanced technologies in spinal surgery, with developments in areas such as...

Spinal surgery training adapted during COVID-19 pandemic

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...

COVID-19 market impact sees ATEC terminate acquisition of EOS imaging

Alphatec Holdings (ATEC) has terminated the tender offer agreement (TOA), dated 26 February 2020, under which it was to acquire EOS imaging for up...

Spine practitioners turn to telemedicine at the height of COVID-19

Telemedicine and virtual consultations are becoming increasingly prevalent in spine care, as healthcare providers seek to adapt practices amid the pandemic. A recent Scoliosis...

US FDA clearance for Atlas Spine’s HiJAK SA system

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...

Life Spine announces FDA 510(k) clearance of the PROLIFT Lateral Fixated...

Life Spine receives approval from FDA
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...

Precision Spine announces US launch of Reform midline cortical system

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...

Nexxt Spine announces first implantation of Matrixx corpectomy system

Nexxt Spine has announced the first effective implantation of the Nexxt Matrixx corpectomy system following US Food and Drug Administration (FDA) clearance. The corpectomy...

Astura Medical receives FDA 510(k) clearance for SIRION LLIF system

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...

“Challenges and opportunities” NASS president reflects on COVID-19 and spine care

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,...

PPE and economic concerns highlighted in global COVID-19 spine survey

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...

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...

Artificial intelligence in spine care is “here to stay”

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,...

Spinal ultrasound imaging platform receives US FDA clearance

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...

Centinel Spine receives FDA approval for two-level indications of prodisc L

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...

Signus receives CE mark for ALIF and cervical cages

Signus has announced that it has received CE mark approval for two implants in its product portfolio, the BIG ST anterior lumbar interbody fusion...

Precision Spine launches Reform Ti pedicle screw system

Precision Spine has launched worldwide the Reform Ti titanium pedicle screw system, designed to provide increased flexibility, versatility, and visibility to take on challenging...

Stryker develops Emergency Relief Bed in response to COVID-19 pandemic

Stryker
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...

UK regulator review sees NuVasive suspend supply of Magec rods

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)...

OrthoPediatrics announces ApiFix acquisition

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...

Spinal News International Issue 54 – March 2020 US Edition

Highlights: Starker than expected radiation from fluoroscopy in TLIF surgery Highlights from ISASS 2020 Profile: Alex Vaccaro Lawrence Lenke discusses technology and the changing...

Spinal News International Issue 54 – March 2020 EU Edition

Highlights: Starker than expected radiation from fluoroscopy in TLIF surgery Highlights from ISASS 2020 Profile: Alex Vaccaro Lawrence Lenke discusses technology and the changing...

ACS defends healthcare workers as PPE shortages lead to acrimony

The American College of Surgeons (ACS) today leapt to the defense of healthcare workers who are heading to work in the face of increasing...

SpineGuard receives CE mark for DSG Connect platform

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...

Nexxt Spine announces US FDA clearance for Matrixx corpectomy system

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...

OrthoPediatrics gains expanded approval for Response scoliosis system

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...

Surgery preferable to conservative treatment in chronic sciatica patients

Patient-reported functional outcomes vary considerably after lumbar spinal fusion surgery
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...

Lessons from Milan: Spine care and COVID-19

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...

AgNovos receives Breakthrough Device Designation for spine device

AgNovos
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...

NASS issues call for papers for new open access journal

The North American Spine Society (NASS) is issuing a call for papers for NASSJ, a new open access journal. NASSJ aims to facilitate the...

American College of Surgeons releases clinical guidance for elective surgery triage...

The American College of Surgeons (ACS) has published guidance for surgeons to curtail recommendations for elective surgical procedures to preserve resources for the care...

NASS offers Coronavirus resources for spine care providers

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...

Elective spinal surgery “should be curtailed” in light of Coronavirus outbreak

minimally invasive surgery
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...

Life Spine to produce surgical masks during COVID-19 outbreak

Life Spine receives approval from FDA
Life Spine a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders has announced a partnership...

Precision Spine launches SureLOK MIS 3L percutaneous screw system

Precision Spine has nationally launched the SureLOK MIS 3L percutaneous screw system in the USA. The SureLOK system can be used in a number...

NuVasive issues safety notice on Magec Model X rods

NuVasive has issued an urgent field safety notice for the recall of Magec System Model X rods. The notice, issued on 13 February, indicates...

Researchers describe technique to “re-inflate” herniated disc

A research collaboration led by Cornell University (Ithaca, USA) professor Lawrence Bonassar has led to the development of a new technique for the treatment...

Current evidence and future uses of BMP in spinal surgery

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...

“Starker than expected” radiation from fluoroscopy in TLIF surgery

A study of radiation exposure among patients undergoing transforaminal lateral interbody fusion (TLIF) surgery presents a “starker than expected” difference in dosage between patients...

Frank Phillips named as ISASS president

Frank Phillips (Rush University Medical Center, Chicago, USA) was named president of the International Society for the Advancement of Spine Surgery (ISASS) during the...

Centinel Spine announces Steven F Murray as CEO

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,...

Study supports use of Attrax Putty as substitute for autograft

NuVasive has announced the results of a study supporting the use of Attrax Putty as a standalone bone graft substitute for autograft in instrumented...

Coronavirus leads to cancellation of spine meetings

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...

Does insurance status play a role in predicting outcomes after surgery?

Following on from studies examining the socioeconomic and racial factors influencing the outcomes from spinal surgery, Jonathan Rasouli (Cleveland Clinic, Cleveland, USA) and colleagues...

FDA clearance for use of Agilon bone graft in spine procedures

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...

DiscGenics completes enrolment for IDCT clinical trial

idct
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...

Life Spine receives additional US FDA clearance for the PROLIFT expandable...

Life Spine has received an additional clearance from the US Food and Drug Administration (FDA) to market the Lateral PROLIFT expandable system. The company...

icotec ag and AO Foundation partner for spinal stabilisation system

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...

Positive fusion data reported for FlareHawk interbody implant

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...

ISASS20: PEEK-on-ceramic disc shows decrease in pain and disability scores after...

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...

ISASS20: Opioid use lower for Prestige LP cervical disc patients

The percentage of patients using opioid medication once or more a day after receiving the Prestige LP cervical disc arthroplasty (CDA) (Medtronic) was statistically...

ISASS20: PEEK cervical disc improves MRI scan visualisation

Simplify Disc
The use of a polyetheretherketone (PEEK) cervical disc allows for significantly improved visualisation of surrounding spinal and neuro structures on postoperative magnetic resonance imaging...

ATEC agrees to acquire EOS imaging

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...

Texas Back Institute performs first minimally invasive case with DeGen’s E3...

DeGen Medical has announced the first implant of the E3 MIS pedicle screw system at Texas Back Institute in Plano, USA. The minimally invasive...

RTI to showcase SImmetry clinical data at ISASS20

RTI Surgical will showcase its body of clinical data on the SImmetry sacroiliac joint fusion system at the 2020 International Society for the Advancement...

Enrolment for two-level prodisc patient study begins

Enrolment has begun in the USA for a new patient study featuring two artificial cervical discs designed by spinal device manufacturer Centinel Spine, the...

Image-guided screw placement offers “advantage” in instrumented spinal surgery

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...

Genesys Spine launches Sacroiliac Joint Fusion system

Genesys Spine has announced the launch of its Sacroiliac Joint Fusion system. The system consists of partially threaded and fully threaded implants designed to...

Driving culture to improve safety in spine surgery

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...

US patent granted for CTL’s screw offset blocking mechanism

CTL Amedica
CTL Amedica Corporation has been granted an official patent from the US Patent and Trademark Office for a screw offset blocking mechanism, which has...

Preliminary results validate NuVasive’s MaXcess retractor in prone single-position XLIF and...

MaXcess retractor
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...

PROM questionnaires added to Orthofix STIM onTrack mobile app

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...

Untreated AIS patients report low scores for pain, self-image and function

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...

Five-year data released for Inspan lumbar interspinous fixation device

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...

US FDA approval for Medicrea’s patient-matched interbody cages

Medicrea logo
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)...

Peri-operative pregabalin does not reduce pain in adolescents after posterior spinal...

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,...

Life Spine receives US FDA 510(k) clearance for Steerable Plateau Ti...

Life Spine receives approval from FDA
Life Spine has announced that it has received 510(k) clearance from the US Food & Drug Administration (FDA) to market the Steerable Plateau Ti...

Technology and the changing role of the spine surgeon

Virtual reality, including 3D imaging, will play an increasing role in planning complex spinal deformity surgery in the near future, according to Lawrence Lenke...

Hedron IA 3D printed ALIF spacer used in vertebral body fixation...

Globus Medical has announced the first procedure using the Hedron IA implant, a 3D printed integrated ALIF spacer that leverages anchors or screws for...

7D Surgical announces commercial release of its Universal Tracking Kit

7D Surgicals Hero 2 machine
7D Surgical has announced the commercial release of its Universal Tracking Kit which spine surgeons can use to track and visualise almost any rigid...

NASS publishes evidence-based guideline for diagnosis and treatment of low back...

Patient-reported functional outcomes vary considerably after lumbar spinal fusion surgery
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...

Device removal not mandatory to combat acute infection after ASD surgery

Surgeons should consider removal or replacement of implants following adult spinal deformity (ASD) surgery only in cases where there is recurrent infection or evidence...

Atlas Spine launches V3 guided segmental plating system

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...

Life Spine publishes white paper on ProLift expandable spacer system

  Life Spine has announced today the publication of a white paper examining the immediate restoration of patient disc height, foraminal height and lordosis with...

Nanocoated PEEK cages improve osseointegration in PLIF procedure

Investigators have found that nanocoated polyetheretherketone (PEEK) cages for posterior lumbar interbody fusion (PLIF) achieve a better fusion rate than uncoated PEEK cages at...

First North American installation of EOSedge imaging system

  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...

Inspired Spine performs 1,000 OLLIF procedures

Inspired Spine
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,...

CoreLink passes 5,000 3D printed spinal implant milestone

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...

Synaptive announces updates to Modus V robotic microscope

Modus V, a fully automated robotic digital microscope designed to assist surgeons in the operating room.
Synaptive Medical has announced the US and Canadian availability of updates to its flagship surgical technology product, Modus V, a fully automated robotic digital...

Study looks at impact of race on outcomes of spinal fusion...

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...

CIMZIA approved for use by Health Canada

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...

Medicrea in discussions over potential US strategic partnerships

Medicrea logo
The Medicrea Group has announced that it is in active discussions with potential US strategic partners in the spine industry with the intention to...

Cutting Edge Spine receives FDA 510(k) clearance for EVOL ha-DLIF system

  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...

Researchers push ‘defined’ role for DVT treatment after spine surgery

minimally invasive surgery
A review of bleeding and thrombotic complication rates in elective spine surgery patients has suggested that further study is needed to “define the role”...

Medtronic issues safety notice after Mazor X detachments

Medtronic has issued a field safety notice over its Mazor X Surgical System, after reports that certain versions of the device had unexpectedly disconnected...

Bone Biologics completes rhNELL-1 preclinical study

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...

Japanese study of disc degeneration cell therapy passes safety review

idct
IDCT (DiscGenics) has passed the initial safety review of its double blinded clinical study evaluating the allogenic, injectable disc cell therapy in Japanese patients...

Medicrea receives seven US patents for UNiD spinal AI platform

Medicrea logo
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...

Study assesses reliability of PROM score change in spine surgery research

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...

The relevance of intraoperative neuromonitoring for spine surgery

neuromonitoring
Intraoperative neuromonitoring (IONM) was introduced several decades ago and is an increasingly favourable option for delicate surgeries. A recent study1 indicates that IONM procedures...

NuVasive appoints Matthew Harbaugh as chief financial officer

Nuvasive has announced the appointment of Matthew K Harbaugh as executive vice president and chief financial officer (CFO) effective immediately. Harbaugh succeeds Rajesh J...

SeaSpine announces commercial launch of Mariner Midline posterior fixation system

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...

FDA approves xvision augmented reality spine surgery system

Augmented reality
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...

Life Spine receives FDA 510(k) clearance for the titanium stand-alone ALIF...

Life Spine receives approval from FDA
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...

Margareta Nordin

Margareta Nordin in spine care
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...

Spine surgery ‘safe’ in patients of advanced age

frailty
Spine surgery in patients of advanced age is safe to perform as older age itself is not a risk factor, surgeons from seven institutions...

RTI Surgical announces publication of TETRAfuse PEKK study

tetrafuse
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...

Jana Kiena appointed chief financial officer of Aurora Spine

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...

Patient factors explain variation in function after lumbar surgery

Patient-reported functional outcomes vary considerably after lumbar spinal fusion surgery
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;...

ulrich medical USA launches Momentum rod-screw system

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...

Empirical Spine completes investigational enrolment for LimiFlex US IDE trial

Empirical Spine has announced completion of enrolment in the investigational arm of its US Investigational Device Exemption (IDE) trial studying the use of the...

Taking NASS to the global stage

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...

Topical application and local infiltration of TXA reduces blood loss in...

Topical application of tranexamic acid (TXA) before wound closure has been found to have better postoperative blood conserving effects in elective spine surgery, compared...

Terry Rich joins RTI Surgical as president of Global Spine

RTI Surgical
RTI Surgical Holdings, has announced that Terry Rich has joined the company as president of Global Spine. In a press statement, RTI said that...

EOS imaging receives 510(k) clearance for EOSedge

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...

Positive results for Taltz in COAST-X trial

Taltz Eli Lilly and Company
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...

SpineScan: A key to lean process management to improve quality and...

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...

Spinal News International Issue 53 – November 2019 US edition

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...

Spinal News International Issue 53 – November 2019 EU edition

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...

Shape analysis could predict postoperative results in AIS surgery

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...

The invisible cost of spine surgery

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...

Life Spine receives FDA 510(k) clearance for Longbow titanium lateral expandable...

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...

NuVasive receives FDA clearance for expanded multi-level use of CoRoent small...

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...

CSRS 2019: DePuy Synthes launches Symphony OCT system

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....

No clinical benefit in antibiotic use to treat low back pain

Patient-reported functional outcomes vary considerably after lumbar spinal fusion surgery
Three months of treatment with amoxicillin did not provide a clinically important benefit in patients with chronic low back pain and Modic changes, a...

Life Spine announces first cases with Centerline thoracolumbar spinal system

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...

Cerapedics announces FDA approval of PMA supplement based on two-year clinical...

Cerapedics
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...

Astura Medical receives 510(k) clearance for ALTA anterior cervical corpectomy spacer...

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...

Comorbidities and surgical complication linked to increased readmission after revision lumbar...

Relevant patient comorbidities and surgical complications are associated with increased readmission within 90 days of elective revision lumbar fusion surgery, a retrospective study published...

Novartis announces results of PREVENT study

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...

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...

Outcomes of SCOUT interbody fusion trial detailed

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...

Nevro receives US FDA approval for Senza Omnia spinal cord stimulation...

  Nevro has received approval from the US Food and Drug Administration (FDA) for the Senza Omnia spinal cord stimulation system to treat chronic pain....

Astura Medical announces Texas relocation

Astura
Spine technology company Astura Medical has announced the relocation of its corporate headquarters from Carlsbad, California to Irving, Texas. The move was effective November...

AI-based classification may guide preoperative decisions in ASD patients

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...

Stryker receives FDA 510(k) clearance for Sahara Lateral 3D interbody system

Stryker Sahara
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...

Laboratory markers could predict outcomes for spinal metastases patients

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,...

Behavioural intervention increases physical activity in lumbar surgery patients

A psychosocial behavioural intervention administered in the spine care setting was successful in increasing physical activity after recuperation from lumbar surgery, a trial has...

IDCT clinical study passes final safety review

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...

GTX Medical and NeuroRecovery Technologies announce merger

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...

Stryker completes acquisition of Mobius Imaging

Stryker
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...

EUROSPINE 2019: Decompressive surgery remains the ‘gold-standard’ for lumbar spinal stenosis...

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...

Synaptive offers Modus V surgical microscope to spine market

Synaptive Medical will offer its robotic surgical microscope, Modus V, to the spine market as part of an expanded marketing agreement with Stryker. The...