Medtronic's Kyphon HV-R Bone Cement receives 2nd indication: 4 key points


The FDA awarded approval for a second indication of Medtronic's Kyphon HV-R Bone Cement.


Here are four things to know:

1. The new indication allows clinicians additional options for treating patients with sacral insufficiency fractures; they can use the bone cement to treat sacral vertebral bodies using either vertebroplasty or sacroplasty.

2. The Kyphon HV-R cement can be used with the Kyphon Xpede Bone Cement for patients with sacral insufficiency fractures. The fractures typically cause debilitating pain and two-thirds of patients with sacral insufficiency fractures don't attribute the fracture to a single traumatic event.

3. Patients with sacral insufficiency fractures may be prescribed conservative treatment, including prolonged bed rest and prescription narcotics; some spend 20 to 45 days in the hospital.

"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 Labib F. Haddad, an interventional radiologist with St. Luis-based West County Radiological Group.

4. The early intervention for sacral insufficiency fractures could provide better patient outcomes and lower hospital costs, according to Vice President and General Manager of the Interventional Pain Therapies business of Medtronic's Restorative Therapies Group Jeff Cambra.

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