Dublin-based Medtronic has announced the FDA 510(k) approval of its Kyphon Xpede Bone Cement, a product to treat sacral fractures through minimally invasive operations.
Here's what you need to know:
1. The Kyphon Xpede Bone Cement fixates pathological fractures of the sacral vertebral body or ala with sacral vertebroplasty or sacroplasty, making the product ideal for many procedures including vertebral fractures due to osteoporosis, cancer and benign lesions.
2. The National Osteoporosis Foundation reports 54 million Americans have osteoporosis and low bone mass, two factors making them more susceptible to hip, spine, sacrum and wrist fractures.
3. A recent study treated 243 patients suffering from osteoporotic sacral insufficiency fractures with sacroplasty and yielded pain-relieving results after one year. The study reported a complication rate of only 0.4 percent.
4. Interventional Pain Therapies general manager Jeff Cambra, of Restorative Therapies Group at Medtronic, said, "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."
5. Kyphon Xpede Bone Cement provides ease of handling and can be used in minimally invasive operations.
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