The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of Kyphon(TM) HV-R Bone Cement for fixation of pathological fractures of the sacral vertebral body (or ala) using sacral vertebroplasty or sacroplasty announced today by Medtronic plc (NYSE: MDT).  This broadens Medtronic’s commitment to treat fragility fractures beyond vertebral compression fractures caused by osteoporosis, cancer or benign lesions. With this expanded indication for Kyphon HV-R Bone, clinicians now have more options for treating patients with sacral insufficiency fractures.

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

Sacral insufficiency fractures (SIFs) are a common cause of debilitating back pain. SIFs mimic the symptoms of lumbar spine pathology.1 Studies show more than two-thirds of patients diagnosed with SIFs aren’t able to associate their pain with a traumatic event.2 As a result, physicians often prescribe conservative treatment, including physical therapy and prolonged bed rest. These patients report 20-45-day inpatient stays1 at the hospital, and prescription narcotic use associated with pain from untreated sacral insufficiency fractures, which are significant expenses to the healthcare system and result in lost productivity. Patients treated with bed rest are at increased risk of pulmonary embolism and DVT, as well as further muscle atrophy and bone loss.3

“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,” said Dr. Labib F. Haddad, interventional radiologist, West County Radiological Group, St. Louis, Mo. “The procedure of sacroplasty with HV-R cement is a minimally-invasive procedure usually performed in an outpatient setting.”

“Early intervention is an important consideration for both hospital costs and patient outcomes,” said Jeff Cambra, vice president and general manager of the Interventional Pain Therapies business, which is part of the Restorative Therapies Group at Medtronic. “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.”

Note:  Kyphon Xpede Bone Cement and Kyphon HV-R Bone Cement are indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e., kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height. Balloon kyphoplasty incorporates technology developed by Gary K. Michelson, M.D.