X-spine Systems, an emerging manufacturer of implants and instruments for spinal surgery, announces FDA clearance of its new Calix spinal implant system.
Spine
Depuy Spine Launches Healos® Fx Injectable Bone Graft Replacement – For Minimally Invasive Spine Procedures
DePuy Spine, Inc. announced the launch of HEALOS® Fx Injectable Bone Graft Replacement (HEALOS Fx), the company’s first bone graft solution designed specifically for minimally invasive spine surgery (MIS).
ISTO Technologies, Inc. Announces FDA Approval to Initiate a Clinical Trial for a Novel Treatment for Disc Nucleus Regeneration
STO Technologies, Inc. announced today that it has received notification from the U.S. Food and Drug Administration allowing the company to proceed with a Phase I clinical study for NuQu, a cell-based injectable formulation of juvenile chondrocytes designed to regenerate cartilage, restore disc function and relieve discogenic back pain.
Magellan Spine Technologies Receives CE Mark for the DART Spinal Disc Annular Repair Technology
Magellan Spine Technologies, Inc. announced today receipt of the CE Mark for the Company’s DART Disc Annular Repair Technology System. This patented technology is used to seal the access site in the annulus fibrosus following lumbar spine microdiscectomy.
NuVasive Announces Acquisition of Cervical Total Disc Replacement Device
NuVasive, Inc., a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today that it has agreed to purchase Cervitech® Inc., a New Jersey based company focused on clinical approval of the PCM® cervical disc system, a motion preserving total disc replacement device.
LDR Announces FDA Clearance of Its ROI-A ALIF Device
LDR, a total spine solution company, announced that it received FDA clearance on Feb. 2 to market its ROI-A™ implant as an anterior lumbar interbody fusion (ALIF) device.
U.S. advisers reject wider Stryker bone putty use
Stryker Corp’s bone-growth putty for spinal surgery should not be approved for expanded use in a wider population, advisors to federal drug regulators said on Tuesday.
NovaLign nabs FDA approval for bone fixation system
NovaLign Orthopedics Inc. can now market its first product, a bone fixation system, after it received clearance from the Food and Drug Administration.
All-Inclusive Solution For Rigid Posterior Fixation Of The Cervico-Thoracic Regions Of The Spine
K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, announced the introduction of an all-inclusive solution for rigid posterior fixation of the cervico-thoracic regions of the spine, the CASPIAN™ Spinal System.
Heavy Lifting: Spinal Fractures No Reason To Sacrifice Height, Says Orthopaedic Medical Device Expert
AOI has pioneered a better way to treat VCF. The company’s lead product, Ascendx™, is used to restore height by pushing on the bone walls while simultaneously delivering a medical grade bone cement, uniformly filling the cavity, thereby restoring height and allowing equal forceload distribution to the vertebra.
Surgeons Perform Minimally Invasive Spine Surgery With US Spine’s Lock-Tight™ Device
Spine surgeons at Middlesex Hospital in Middlesex Connecticut have performed a minimally invasive, posterior spinal fixation procedure using the Lock-Tight™ Facet System, a groundbreaking new technology that enables surgeons to fixate the facet joint without needing to perform an open procedure.
Artificial Disc Replacement As Good Or Better Than Spinal Fusion Surgery
Spine surgeons at Washington University School of Medicine in St. Louis and other U.S. centers are reporting that artificial disc replacement works as well and often better than spinal fusion surgery.
A Mini-Invasive Spinal Repair Technique May Offer Hope To Vertebral Fracture Patients
Giving patients with acute vertebral fractures balloon kyphoplasty treatment improves quality of life and reduces disability and back pain compared with conventional non-surgical management, and is a safe and effective technique, finds The Lancet.
Bone Biologics Announces Significant Milestone For Spinal Fusion Surgery Using Recombinant Protein And Demineralised Bone Matrix
Bone Biologics, Inc. announced that it has successfully completed the initial primate trials validating the efficacy of the proprietary bone growth regeneration UCB-1 (NELL-1) protein in spinal fusion surgery.
Salient Surgical Technologies Launches New Advanced Energy Device Designed to Improve Patient Outcomes in Spine Surgery
Salient Surgical Technologies, Inc. today unveiled the Aquamantys™ Epidural Vein Sealer (EVS) bipolar device at the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting in Las Vegas, NV.
Largest Study on Balloon Kyphoplasty Demonstrates Superior Benefits Compared to Non-Surgical Care in Treating Vertebral Compression Fractures
In the largest multicenter randomized controlled study of surgical intervention versus non-surgical care for acute vertebral compression fractures, patients undergoing balloon kyphoplasty showed superior improvement in quality of life, back function and back pain than those who were given non-surgical care.