The FDA granted Medtronic 510(k) clearance of KyphonHV-R Bone Cement for treatment of pathological sacral vertebral body fractures using sacral vertebroplasty or sacroplasty.
Here's what you should know:
1. Kyphon Xpede Bone Cement and Kyphon HV-R Bone Cement treat vertebral body pathological fractures resulting from osteoporosis, cancer or benign lesions using cementoplasty.
2. The expanded indication for Kyphon HV-R Bone gives physicians a new option for treating sacral insufficiency fractures, beyond conservative treatments such as physical therapy and prolonged bed rest.
2. Medtronic believes the expanded indication can improve outcomes, saying patients who undergo conservative treatments report 20-day to 45-day hospital stays and prescription narcotic use for pain.
4. By contrast, sacroplasty with HV-R cement is typically a minimally-invasive procedure usually performed in an outpatient setting, according to Interventional Radiologist Labib F. Haddad, MD, of St. Louis-based West County Radiological Group.
5. The FDA approval expands Medtronic's ability to treat fragility fractures beyond vertebral compression fractures caused by osteoporosis, cancer or benign lesions.
"Early intervention is an important consideration for both hospital costs and patient outcomes," said Medtronic's Interventional Pain Therapies Vice President and General Manager Jeff Cambra. "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."