Archive for the 'Spine' Category

ROI-C cervical cage approved by the FDA

ROI-CThe FDA has approved Austin surgical device maker LDR’s ROI-C cervical cage. This product helps in standalone cervical fusion surgeries, making it less necessary to use thick cervical plates that contribute to dysphagia or difficulty swallowing. LDR CEO Christophe Lavigne said “The entry of the ROI-C cervical cage into the U.S. market represents a huge step for us in continuing to provide innovative, surgeon-friendly solutions for varied spinal pathologies.”

Study finds outcome of spine fusion similar to hip and knee joint replacement

spineA study conducted by a team of Australian researchers indicated that spinal decompression and fusion surgery for degenerative spondylolisthesis is able to generate significant and substantial improvements in health-related quality of life. The improvements are equivalent to the published outcomes of hip and total knee joint replacement. The cost-utility analysis of spine fusion provided excellent outcomes, according to the Australian researchers.

FDA clearance for Amedica’s SEEplate(TM) Cervical Plate system for marketing

The U.S. Food and Drug Administration has given 510(k) clearance to Amedica Corporation, SEEplate(TM) Cervical Plate system. The system incorporates features which aim at giving surgeons an alternative to the current surgical procedures that are being followed. It facilitates anterior screw fixation, thereby suiting the patient anatomy. In this way, a more consistent supplemental fixation result can be achieved for various applications such as including degenerative disc disease and spinal stenosis.

Medtronic launches X-STOP PEEK IPD System

Medtronic, Inc. has launched its X-STOP PEEK IPD System. It must be noted that this is the first IPD device offering a PEEK-Bone interface for treating the symptoms of lumbar spinal stenosis (LSS) that has received an approval from the U.S. Food and Drug Administration . Spine surgeons, now, have the option of using PEEK in IPD procedures providing benefits like radiolucency and biocompatibility. The minimally invasive treatment for LSS is made up of titanium alloy.

FDA clears Biospace med’s EOS X-ray imager

The U.S. Food and Drug Administration has cleared Biospace med’s EOS X-ray imager for market launch. The device is helpful in procedures related to spine, hip and knee. EOS captures head-to-toe images of patients in a weight-bearing position. The radiation dosage is 10 times lesser than a conventional X-ray and 1000 times less than a CT scan. Additionally, the new stereos and measurement workstation enable 3D reconstruction and reduce the time taken for surgical planning, making orthopedic procedures simpler.

Orthoview releases version 5.2

OrthoView™, has launched its new version 5.2 software. Developing the already feature-rich OrthoView 5.1, OrthoView 5.2 comes up as a more refined version with additions to the module of spine deformity assessment. Radiologists and orthopedic surgeons across the world had been looking forward to the advancement in the software. Procedures like joint replacement and trauma become much more sophisticated with the digital templates that the OrthoView solutions provide for. The precision tools included for the spine module in the latest version simplify the assessment process associated with pediatric scoliosis.

StemCor’s MarrowMiner System receives CE Mark

StemCor Systems, Inc., has received the CE (Conformite European) Mark for its MarrowMiner System, a minimally invasive device which is used to harvest adult stem cells from the pelvis. The next-generation technology is brought in use for bone marrow transplants, to accelerate bone healing in orthopedic procedures such as spinal fusions, and in a number of clinical applications that utilize bone marrow-derived cells. The CE Mark confirms the appropriate quality and safety that StemCor’s systems are known to follow.

FDA expands Endoskeleton’s approval to 510 K indication

The US Food and Drug Administration has expanded Titan Spine‘s ENDOSKELTON® TA Vertebral Body Replacement Device (VBR) 510k to include an Interbody Fusion Device indication. The expanded 510K indication, means that the device is approve for the use in skeletally mature patients with Degenerative Disc Disease (DDD). Patients should have received six months of non-operative treatment prior to treatment with the devices. The device may be used with supplemental fixation. It will enable the surgeon to utilize the Endoskeleton TA as an Interbody Device while taking off the VBR label. The device will make the surgeons comfortable by providing them the option to use the device in a stand-alone setting.

DePuy Spine launches innovative bio-implant for cervical fusion surgery

DePuy SpineDePuy Spine Inc., a Johnson & Johnson company, has launched the VERTIGRAFT® VG1® CERVICAL ALLOGRAFT, an innovative bio-implant for anterior cervical fusion surgery designed to align with the spinal anatomy for maximum stability and freeze-dried for easy storage. VG1 CERVICAL’s trapezoidal design matches the anatomy of the cervical spine and its open central chamber allows surgeons to add graft material of their choice.

Pioneer Surgical NuNec device successfully implanted in human

SpiinePioneer Surgical Technology Inc. has announced the successful human implantation of its next generation cervical total disc replacement (TDR), NuNec Cervical Arthroplasty Device. The surgeries were conducted on patients with degenerative disc disease (DDD) otherwise indicated for standard fusion surgery. Unlike many cervical disc devices, the radiolucency of the PEEK material in NuNec causes no artifact in MRI or CT imaging and is easiest to implant.

Photo by heyjoewhereyougoin withthatguninyourh and

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