The FDA today authorized the 1st prosthesis for patients with amputations above the knee, allowing them to attach a prosthetic limb to remaining thigh bone.
The device, called the Osseoanchored prosthesis for the rehabilitation of amputees, uses fixtures and screws implanted in a patients remaining thigh bone to connect to an external prosthetic, the FDA said.
The device, produced by Swedish medtech firm Integrum AB, allows patients with remaining limb portions too short to connect to traditional prosthetics to use specially made prosthetic devices.
“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. 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,” FDA Center for Devices and Radiological Health director of device evaluation Dr. William Maisel said in a press release.
The OPRA device installation requires 2 surgical procedures 6 months apart, the FDA said. In the 1st procedure, a cylindrical fixture is implanted into the thigh bone’s central canal and is given time to heal around the fixture.
The 2nd surgery implants a rod that extends through the bottom of the patients limb that can connect to a prosthetic leg, the FDA said.
Using the new prosthesis requires around 6 months of physical therapy with a training prosthesis before patients are fitted with their own custom prosthetic, the FDA said.
The device won a humanitarian use designation from the FDA based on mechanical testing and a 2-year, 51-patient clinical trial.