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Integra LifeSciences receives FDA approvals for three spinal fixation devices
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Integra LifeSciences Holdings Corporation announced in a press release that the corporation has received 510k clearance from the U.S. FDA for three new spinal intervertebral body fusion devices.
According to the release, each intervertebral body fusion device (IBD) system was engineered to help simplify the surgical procedure and eliminate unnecessary steps. The new spinal fixation systems are the Cervical Stand-alone IBD, Vu cPOD Non-Strut IBD, and Steerable IBD.
The systems are currently in limited commercial release and are targeted for full commercial release later this year.
IBDs are small, hollow spinal implants that are inserted into the intervertebral space to restore physiological disc height and to allow fusion between vertebral bodies. According to the release, these devices relieve pressure on the nerves and associated back pain by maintaining the natural disc space height and by providing positive mechanical stabilization of the vertebrae. The graft window in the device allows natural bone growth to occur through the IBD and form a strong vertebral union that incorporates the implant.
“This is a testament to Integra’s engineering expertise and a strong indication of our continued commitment to bring innovative solutions to market,” Brian Larkin, Integra’s president, global spine and orthobiologics, and head of strategic development, stated in the release. “Our customers choose Integra because we are able to deliver quality medical devices through a collaborative approach with our surgeons.”