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Medtronic receives FDA 510(k) clearance for bone cement indicated for treatment of sacral fractures
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Medtronic announced it has received FDA 510(k) clearance for Kyphon Xpede bone cement for treatment of pathological fractures of the sacral vertebral body, according to a recent release.
The Kyphon is a bone cement that is reportedly easy to handle and offers surgeons enough time for minimally invasive use. It may minimize radiation exposure in clinicians when used in combination with the Kyphon cement delivery system and they are standing 4 feet away from the source of radiation.
“We are pleased to expand our therapies for interventional physicians treating osteoporotic patients to include those suffering from sacral insufficiency fractures,” Jeff Cambra, general manager of the Interventional Pain Therapies business, which is part of the Restorative Therapies Group at Medtronic, said in the release. “As the pioneers in balloon kyphoplasty for treating vertebral compression fractures, this expanded indication for Kyphon Xpede Bone Cement demonstrates our long-term commitment to continuously innovate and empower physicians to deliver the best clinical solutions to their patients.”
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