Spinal Fusion Articles & Analysis
33 news found
The Case Series, authored by Kai-Uwe Lewandrowski, M.D., details a novel endoscopic transforaminal lumbar interbody fusion technique using the VariLift-LX stand-alone expandable interbody fusion device. ...
Empirical Spine, Inc., a company developing advanced solutions for the surgical treatment of spinal disorders, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its LimiFlex™ Paraspinous Tension Band. ...
Empirical Spine, Inc., maker of the LimiFlex™ Paraspinous Tension Band, today announced initiation of the PMA process for FDA review and approval of the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The Pivotal Trial supporting the PMA compares outcomes of patients who receive ...
The LimiFlex DST is the first-of-its-kind surgical option for grade 1 degenerative spondylolisthesis (degen spondy) patients with spinal stenosis. Recognized with FDA’s Breakthrough Device Designation, LimiFlex has the potential to offer grade 1 degen spondy patients a better solution compared to current options such as fusion. ...
The advanced handling properties of the new products make them ideal for spinal fusion and other orthopedic applications. “We now have even better options for surgeons who focus on putting their patient’s needs front and center,” said Nelson Scarborough, PhD,Bone Technology Coach at Isto Biologics, and inventor of the Fibrant Technology. ...
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 surgery-related complications and re-operations. ...
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 ...
Cerapedics Inc., an ortho-biologics company dedicated to enhancing the science of bone repair, announced today the completion of enrollment of the ASPIRE study, a pivotal U.S. 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 ...
The Dynamic Sagittal Tether is intended to be an alternative to spinal fusion, which has persistent and well-documented drawbacks, including being highly invasive, increasing risk of long-term sequelae, and high costs. ...
“Patients prefer motion-preserving surgeries that are less invasive and have faster recovery than lumbar fusion,” commented Dr. Bae. “LimiFlex is an appealing potential alternative for patients with degenerative spondylolisthesis.” About LimiFlex The LimiFlex Tension Band is a new, investigational device designed as an alternative to ...
” Justin Smith, MD, PhD, Chief of Spine Surgery at the University of Virginia Medical Center, commented, “Data from the multi-institutional Spinal Deformity Study Group has demonstrated that surgery significantly reduces disability and pain and improves the health status for adults of all ages, with the elderly having a disproportionately greater improvement.1 While ...
“Our mission is to provide broad access to this technology for patients suffering from debilitating spinal disorders.” The aprevo® patient-specific interbody fusion devices are made possible by Carlsmed’s proprietary Data to Device™ digital technologies. ...
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 ...
Locate’s portfolio now includes CertOss, a family of synthetic graft substitutes; CognitOss, a controlled and responsive release of antibiotics from a resorbable bone graft for the treatment of osteomyelitis; LDGraft a low dose, controlled-release rhBMP-2 spinal fusion product intended for the treatment of lower back pain caused by degenerative disc ...
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™ ...
Spino Modulation Inc., a subsidiary of Spinologics Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its MIScoli™ system, an innovative vertebral body tethering (VBT) device to treat scoliosis in young adolescents. The FDA Breakthrough Device Program is intended to help patients receive more timely access to ...
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 ...
Awl-in-One Tap is a single-use spinal surgery instrument with disposable neuromonitoring EMG system and digital depth measurement built in. 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 ...
Locate’s portfolio now includes CertOss, a semi-synthetic graft substitute; CognitOss, the same graft substrate as CertOss but designed to elute antibiotics for the treatment of osteomyelitis; LDGraft a low dose, controlled release rhBMP-2 spinal fusion product intended for the treatment of lower back pain caused by degenerative disc disease; and Chondro3, ...