- For immediate release:
The U.S. Food and Drug Administration today approved the Osseoanchored Prostheses Learning System for Amputees Rehabilitation (OPRA), the first implant system marketed in the U.S. for adults with transfemoral transplants – or above knee – and who have or expect to have rehabilitation problems with, or cannot use, a normal socket prosthesis.
“Today’s agreement on the OPRA Implant System expands options for prostheses for individuals who have had levers above the knee and who may be able to help those who have had or may have problems with rehabilitation. and could not benefit from available socket prostheses, ”said Captain Raquel Peat, Ph.D., MP.H., USPHS, director of the FDA’s Center for Orthopedic Appliances and Radical Health Center. “Prostheses can help people who have lost a leg to trauma or cancer regain mobility and become more involved in daily activities.”
A standard leg prosthesis uses a specially fitted cup-like shell called a socket that fits over the remaining part of the patient’s leg (the remaining limb). after turning) to attach the machine to the shaft. Some patients may not have a long enough leftover arm to properly insert a socket prosthesis or they may have other conditions, such as scarring, pain, recurrent skin infections or changes in shape. remaining organs that prevent them from using a prosthesis. with socket. The OPRA Implant System is surgically anchored and embedded into the remaining thigh bone to allow connection to an external prosthetic arm.
The OPRA Implant System has been on the market under humanitarian device release since 2015. Humanitarian use devices are intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is apparent. in 8,000 individuals in the U.S. each year. Today’s agreement expands the number of patients eligible for this device.
The OPRA Implant System is fitted with two surgical procedures. In the first procedure, a cylinder-shaped fixture is inserted into the waterway in the center of the remaining thigh bone. Approximately six months later, after the implant has been anchored to heal the fixture and the skin tightening, a second operation will be performed to attach additional machine parts of the OPRA Implant System to the fixture. furniture from the previous surgery. The OPRA Implant System extends through the skin at the base of the remaining implant and attaches to the prostate.
After the second surgery, the patient works with a trained physical therapist to gradually put pressure on the OPRA Implant System using a training prosthesis. Patients need about six months of training and rehabilitation after the second surgery, before having their own normal prosthesis replaced by a trained prosthetist.
The FDA evaluated the safety and efficacy in a clinical study of 65 participants who received the OPRA Implant System. Efficacy was evaluated using the Questionnaire for People with Transfemoral Dimension, a patient reported an outcome measure that reflects frequency of use, patient mobility, problems with the device and the patient’s overall health. The average improvement in prosthetic use score was on a scale of 100 points, 35.1 points at two years and 39.6 points at five years compared to the scores reported with a conventional socket prosthesis. Adverse events reported during the study included: infection, mechanical problems, pain, injury and opening of the fixture.
Patients should talk to their healthcare providers about the benefits and risks of each prosthetic option.
The FDA reviewed the OPRA Implant System under the Premarket Agreement (PMA) approach. PMA is the most stringent type of device marketing claim required by the FDA and is based on a determination by the FDA that the PMA application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use (s). .
The OPRA Implant System is manufactured by Integrum AB in Mölndal, Sweden.
The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by determining the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for use. human, and medical devices. The organization is also responsible for the safety and security of our country’s food supply, cosmetics, dietary products, products that emit electronic radiation, and for the regulation of tobacco products.