Medtronic wins expanded FDA indications for Kryphon HV-R bone cement

Medtronic (NYSE:MDT) said yesterday it won expanded FDA 510(k) clearance for its Kryphon HV-R bone cement designed for the fixation of pathological fractures of the sacral vertebral body.

The Fridley, Minn.-based company’s Kryphon HV-R bone cement is now indicated for treating pathological fractures of the vertebral body due to osteoporosis, cancer or benign lesions using a cementoplasty procedure.

The cement is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty, the company said.

“Patients who experience sacral insufficiency fractures often suffer a substantial degree of pain and disability. This new indication for Kyphon HV-R cement, along with Kyphon Xpede bone cement will provide another excellent option to help these patients,” Dr. Thomas Andreshak of Maumee, Ohio’s Mercy St. Vincent Medical Center and St. Luke’s Hospital said in a prepared statement.

“Early intervention is an important consideration for both hospital costs and patient outcomes. 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,” Medtronic interventional pain therapies biz GM Jeff Cambra said in a press release

Earlier this month, Medtronic said it won FDA approval for its Deep Brain Stimulation clinician programmer and Activa programming application.

The post Medtronic wins expanded FDA indications for Kryphon HV-R bone cement appeared first on MassDevice.

from MassDevice https://ift.tt/2MMrTJJ