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Medtronic receives FDA 510(k) clearance for bone cement solution for sacral fractures
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Medtronic plc announced it received FDA 510(k) clearance for the Kyphon HV-R bone cement intended to be used for fixation of pathological fractures of the sacral vertebral body using sacral vertebroplasty or sacroplasty.
According to a company press release, this expansion for the Kyphon HV-R bone offers clinicians more options to treat patients with sacral insufficiency fractures.
“Early intervention is an important consideration for both hospital costs and patient outcomes,” Jeff Cambra, vice president and general manager of the Interventional Pain Therapies business, which is part of the Restorative Therapies Group at Medtronic, said in the release. “Combined with our 20 years of experience in vertebral compression fractures, this new indication for our bone cement solution allows us to continue to make an impact on vertebral compression fracture and sacral insufficiency diagnosis treatment in the U.S. by giving physicians options to deliver the best clinical solutions to their patients.”
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