FDA approves intervertebral body fusion device
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Binder Biomedical Inc. announced that the FDA has cleared its LOGIC, a stand-alone intervertebral body fusion device. The device is indicated for use in patients with degenerative disc disease at one or two contiguous levels of the lumbosacral spine.
LOGIC is an implant that works as a complete anterior lumbar fixation system with a simple, one-step locking mechanism. The implants have large central windows for optimum autograft bone placement and come in different sizes from 10 mm to 20 mm in height. The implant is positioned into the intervertebral space and secured by screws. Alpha release is expected in the first quarter of 2014 with full launch by the end of the year.
“We are excited to bring such a streamlined device to market. Our design team has done a great job putting together such a comprehensive system, ensuring that it can be tailored to any surgeon’s preferred technique,” Lawrence Binder, CEO of Binder Biomedical Inc stated in a company press release.