Medtronic wins extended FDA indication for bone cement
Tuesday, March 14, 2017
Source: Mass Device
Medtronic (NYSE:MDT) said today that it won 510(k) clearance for its Kyphon Xpede bone cement for the fixation of pathological fractures of the sacral vertebral body using sacral vertebroplasty or sacroplasty.
The regulatory win expands the product’s original indications beyond treating vertebral fractures due to osteoporosis, cancer or benign lesion.
Nearly 54 million Americans suffer from osteoporosis and low bone mass, according to the National Osteoporosis Foundation, which places them at a higher risk for a fracture. Bone breaks in people with osteoporosis are most likely to occur in the hip, spine or wrist, Medtronic said.
“Sacral insufficiency fractures are associated with a tremendous amount of pain and debilitation for individuals who have them,” Dr. Douglas Beall, chief of radiology services at Clinical Radiology of Oklahoma, said in prepared remarks. “Having this new indication with Kyphon Xpede Bone Cement to use in the treatment of sacral fractures will help to address this patient population.”
The Fridley, Minn.-based company’s Kyphon Xpede product is a quick-to-dough bone cement that was designed to allow sufficient time for minimally invasive use. Clinicians can pair the product with the Kyphon Cement Delivery system, Medtronic said, and minimize their radiation exposure by standing up to 4 feet away from the radiation source during injection.
“We are pleased to expand our therapies for interventional physicians treating osteoporotic patients to include those suffering from sacral insufficiency fractures,” Jeff Cambra, GM of Medtronic’s interventional pain therapies biz, added. “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.”
A retrospective study of 243 patients with osteoporotic sacral insufficiency fractures treated with sacroplasty found significant pain relief for the patients after the procedure and at the 1-year follow-up mark. The authors also reported that there were no major complications or procedure-related deaths.