The FDA recently announced that it approved Integrum’s prosthetic implant for above-the-knee amputations.
The Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) implant system is the first implant system marketed in the U.S. for adults who have transfemoral amputations and who have anticipated to have rehabilitation problems with, or can’t use, a conventional socket prosthesis.
“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, director of the FDA’s Center for Devices and Radiological Health’s office of orthopedic devices, said in a news release. “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 implant is surgically anchored and integrated into a patient’s remaining thigh bone to allow for a connection to an external prosthetic limb. It’s installed with two surgical procedures. During the first procedure, a cylinder-shaped fixture is implanted into the central canal of the remaining thigh bone. Six months later, a second surgery is performed to attach additional device components of the OPRA implant system to the fixture from the previous surgery. The system then extends through the skin at the bottom of the patient’s residual limb and connects to the prosthesis.
Once a patient completes the second surgery, they work with a trained physical therapist to learn to gradually place weight on the OPRA implant system using a training prosthesis.
The FDA said it evaluated the safety and effectiveness of the implant in a clinical study of 65 participants who received the OPRA implant. The average improvement in the prosthetic use score on a 100-point scale was 35.1 points at two years and 39.6 points at five years when compared to reported scores with a conventional socket prosthesis. Adverse events reported during the study included infection, mechanical complications, pain, injury and loosening of the fixture.
OPRA has been on the market under a humanitarian device exemption since 2015 and the new approval expands the patient population eligible for the deice.
Global law firm Hogan Lovells touted regulatory and scientific guidance it provided Integrum to help it secure the FDA approval.