Friday, July 17, 2015

FDA Approves First-of-Kind Leg Prosthesis

The US Food and Drug Administration (FDA) today approved the first prosthesis for above-the-knee amputations that does not rely on a conventional, cup-like socket fitting over the stump of a patient's leg.
With the new device, called Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA), an external prosthetic limb attaches to a fixture implanted in the patient's remaining thigh bone.

 There is a need for OPRA because not everyone with an above-the-knee amputation is a candidate for a prosthetic limb that connects to a customized stump socket, the FDA said in a news release. "Some patients may not have a long enough residual limb to properly fit a socket prosthesis or may have other conditions, such as scarring, pain, recurrent skin infections, or fluctuations in the shape of the residual limb that prevent them from being able to use a prosthesis with a socket," the agency said.

It takes two surgical procedures to install the OPRA device. First, a cylinder-shaped fixture is implanted in the remaining thigh bone. Six months later, a rod is inserted in the fixture. It extends through the skin at the bottom of the stump and connects to the prosthetic leg.
The FDA approved the new prosthesis through its humanitarian device exemption pathway, which dispenses with the effectiveness requirements found in its normal approval process. Devices can be designated a humanitarian device if they treat or diagnose a condition or disease affecting fewer than 4000 individuals in the United States each year.

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