FDA approved prosthetic implant for patients with transfemoral amputations
The FDA approved the Osseoanchored Prostheses for the Rehabilitation of Amputees Implant System for adults who receive transfemoral amputations and cannot use a conventional socket prostheses, according to a press release.
Useful for patients who do not have a long enough residual limb to fit a socket prosthesis properly, the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System received approval under the premarket approval pathway.
A study of 65 participants evaluated the safety and effectiveness of the implant using the Questionnaire for Persons with a Transfemoral Amputation. Results showed an average improvement on prosthetic use score of 35.1 points at 2 years and of 39.6 points at 5 years, the release noted.
Installed through two surgeries, patients require roughly 6 months of training and rehabilitation before receiving a fitted prosthesis following the procedures, according to the release.
The implant system has been on the market since 2015 under a humanitarian device exemption.
“Today’s approval of the OPRA Implant System expands options for prostheses for individuals who have had above-the-knee amputations and can help those who have had or may have problems with rehabilitation and have not been able to benefit from available socket prostheses,” Raquel Peat, PhD, MPH, USPHS, director of the center for devices and radiological health’s office of orthopedic devices of the FDA, said in the release.
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