FDA authorizes use of prosthesis for rehabilitation of patients with transfemoral amputations

FDA recently announced it has authorized use of the first prosthesis marketed in the United States for adults with transfemoral amputations and who have rehabilitation problems with, or are unable to use, a conventional socket prosthesis.

The Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) device, manufactured by Integrum AB in Molndal, Sweden uses fixtures and screws implanted into the patient’s remaining thigh bone — instead of a socket — to connect the external prosthetic limb.

“Prostheses can help people who have lost a leg due to trauma or cancer to regain mobility and to more easily participate in everyday activities,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health, stated in a press release. “The OPRA device may help those with above-the-knee amputations who have had problems with rehabilitation and have not been able to benefit from available socket prostheses.”

The OPRA device is installed through two surgical procedures in which a cylinder-shaped fixture is implanted into the central canal of the remaining thigh bone and, about 6 months later, a rod is implanted to connect the residual limb to the prosthesis. Patients then undergo about 6 months of training and rehabilitation to place weight on the device using a training prosthesis, before being fitted for a customized prosthesis.

The OPRA device received a Humanitarian Use Device designation and was reviewed through the Humanitarian Device Exemption pathway, according to the release.

Data that led to device approval included mechanical testing of the device parts when subjected to weight, twisting, bending and simulated repeated use, as well as a 2-year, 51-subject clinical trial. The clinical trial found patients reported increased prosthetic use and improved mobility, comfort, function and quality of life compared to their outcomes prior to the surgeries. The most common adverse event was infection.

Reference: www.fda.gov