FDA Clears Kyphon HV-R Bone Cement Solution for Sacral Fractures

Medtronic announced that the US Food and Drug Administration (FDA) granted 510(k) clearance of Kyphon™ high viscosity-radiopaque (HV-R) Bone Cement for fixation of pathological fractures of the sacral vertebral body (or ala) using sacral vertebroplasty or sacroplasty.

The expanded indication allows clinicians to provide more options for patients with sacral insufficiency fractures.

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

Usually performed in an outpatient setting, the sacroplasty with HV-R cement procedure is designed for minimally-invasive surgery.

More than two-thirds of those diagnosed with sacral insufficiency fractures, a common cause of debilitating back pain, are not able to associate pain with a traumatic event, in which case physicians often prescribe conservative treatment. The patients report 20—45-day inpatient stays at the hospital, in addition to being prescribed narcotics—both significant expenses to the health care system which often results in lost productivity. Additionally, those treated with conservative measures like bed rest, are at an increased risk of pulmonary embolism, DVT and further muscle atrophy and bone loss.

“In my practice, patients with sacral insufficiency fractures treated with sacroplasty experience immediate pain relief that allows them to resume daily activity and/or physical therapy without suffering from pain and physical limitations,” Labib Haddad, MD, interventional radiologist, West County Radiological Group, said in a statement.

Kyphon Xpede Bone Cement and Kyphon HV-R Bone Cement are indicated for treatment of pathological fractures of the vertebrae due to osteoporosis, cancer or benign lesions using a cementoplasty (kyphoplasty or vertebroplasty) procedure, and for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty.