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Spine Fusion Articles & Analysis
33 news found
“The ability to successfully perform interbody lumbar fusion using endoscopic access and our stand-alone, expandable interbody device represents the new frontier in Minimally Invasive Spine Surgery. ...
"Our receipt of the Breakthrough Device Designation is a welcome milestone in realizing our mission to improve the quality of life of patients receiving spine surgery," said Richard Treadwell, CEO of Empirical Spine. "We appreciated the collaboration with FDA as we identified and addressed the key questions required to secure this designation. ...
Co-principal investigator Rick Sasso, MD, of the Indiana Spine Group commented, "My experience with LimiFlex has been very positive. ...
Post-fusion rates of adjacent segment degeneration, just one important sequela that can lead to additional fusion surgery, ranging from 30-50% in the literature. ...
Isto Biologics, a leader in surgical-based, orthobiologic regeneration technologies and cell-based therapies, announced today the launch of Influx™ Fibrant, an unprecedented line of functional constructs derived from 100% cortical allograft. The cutting-edge line consisting of five new products includes Fibrant Anchor, Boat, Bullet, Pak and Wrap. The Fibrant launch features the patented ...
This creates elastic resistance to flexion and maintains lordosis, giving patients the stabilization their spines need while preserving normal motion. The Dynamic Sagittal Tether is intended to be an alternative to spinal fusion, which has persistent and well-documented drawbacks, including being highly invasive and expensive and carrying a high risk of ...
Minimally invasive (MIS) lumbar fusion has become a popular alternative to traditional methods of lumbar decompression and fusion. When compared with the open technique, the minimally invasive approach can result in decreased pain and blood loss as well as a shorter length of hospitalization. However, the narrower working channel in the MIS technique increases the difficulty of decortication and ...
Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study, to evaluate the safety and efficacy of P-15L Bone Graft for use in transforaminal lumbar interbody fusion (TLIF) surgery in patients with degenerative disc disease (DDD). ...
The initiative for the update was led by the International Society for the Advancement of Spine Surgery (ISASS), with support and participation from other spine surgery societies and Empirical Spine. ...
Empirical Spine, Inc., a Silicon-Valley based medical technology company, announced today that data from the IDE study of the company’s LimiFlex Tension Band for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis, was presented at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum 2021. ...
--(BUSINESS WIRE)--Carlsmed, Inc., announced today the U.S. launch of the aprevo® patient-specific spine technology and the New Technology Add-On Payment (NTAP) reimbursement. ...
The award is given annually to exemplary and innovative spine surgery products that improve spine care, as judged by a panel that includes leading spine surgeons. ...
CARLSBAD, Calif., Sept. 27, 2021 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced it received simultaneous CE Mark certification for its Cranial Module and Percutaneous Spine Module for the 7D FLASH™ Navigation System. This achievement expands the ...
Enables OrthoPediatrics to Further Address Full Patient Continuum of Care for Pediatric Orthopedic Surgeons with Market-Leading, Radiation-Free Navigation Technology WARSAW, Ind., Sept. 09, 2021 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today ...
Funding to further advance Locate Bio’s regenerative medicine pipeline of orthobiologics Locate Bio, an orthobiologics focused regenerative medicine company, is pleased to announce that it has raised an oversubscribed £10 million of equity investment in a funding round co-led by existing shareholder Mercia Asset Management and new investor BGF. The funding will be used to further ...
CARLSBAD, Calif., July 07, 2021 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the FDA 510(k) clearance of its 7D Percutaneous Spine Module for minimally invasive surgery. This represents a new application and increased functionality for its 7D Flash™ ...
VBT is a promising and lesser invasive alternative to spine fusion, today’s standard of care when adolescents need a surgical intervention to correct a curvature of the spine. ...
CARLSBAD, Calif., May 20, 2021 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the closing of the previously announced acquisition of 7D Surgical. 7D Surgical is a Toronto-based company that develops advanced optical technologies and machine vision-based ...
The device, which is under development, is intended to be used when creating a screw hole pathway during posterior pedicle spinal fusion surgeries. “As more and more spine fusion surgeries move to the outpatient setting, surgeons require the same safety and accuracy of placing surgical screws afforded at the inpatient setting,” said ...
The Company’s second FDA Breakthrough Device designation granted in 2021 Locate Bio, an orthobiologics focused regenerative medicine company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to Chondro3, currently in development as a biomimetic graft for osteochondral lesions. The FDA Breakthrough Device Program is designed ...