FDA Clears Prosthesis for Above-the-Knee Amputations
The FDA on Thursday approved the first prosthesis in the U.S. for adults with amputations above the knee and who are unable to use conventional socket prosthesis.
Manufactured by Swedish devicemaker Integrum AB, the Osseoanchored Prostheses for the Rehabilitation of Amputees relies on fixtures and screws implanted into the patient’s remaining thigh bone to connect an external prosthetic limb.
Surgeons implant the OPRA device over two procedures. During the first, a cylinder-shaped fixture is installed into the remaining thigh bone. Then, six months later, after tissue has grown around the fixture to anchor it and the tissue has healed, a second surgery is performed to implant a rod that attaches to the fixture and connects to the prosthesis.
Clinical trial results demonstrated that patients had increased prosthetic use and improved mobility, comfort, function and quality of life, the FDA says.
The OPRA device was granted a humanitarian use device designation. — Jason Scott