Bone cement solution indicated for treating sacral fractures granted FDA approval

Medtronic announces second bone cement solution indicated for treating sacral fractures

The US Food and Drug Administration (FDA) has granted 510(k) clearance of Kyphon HV-R bone cement (Medtronic) for fixation of pathological fractures of the sacral vertebral body (or ala) using sacral vertebroplasty or sacroplasty.

Medtronic state that this broadens the company’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 cement, clinicians 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,” says Thomas Andreshak (Mercy St Vincent Medical Center and St Luke’s Hospital, Maumee, USA). “This new indication for Kyphon HV-R cement, along with Kyphon Xpede bone cement will provide another excellent option to help these patients.”

Sacral insufficiency fractures are a common cause of debilitating back pain. Sacral insufficiency fractures mimic the symptoms of lumbar spine pathology. Studies show more than two-thirds of patients diagnosed with sacral insufficiency fractures are not able to associate their pain with a traumatic event. As a result, physicians often prescribe conservative treatment, including physical therapy and prolonged bed rest. These patients report 20­­­­­­–45-day inpatient stays 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 deep vein thrombosis, as well as 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 F Haddad (West Country Radiological Group, St Louis, USA) comments. “The procedure of sacroplasty with HV-R cement is a minimally-invasive procedure usually performed in an outpatient setting.”


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