WASHINGTON — The Food and Drug Administration announced approval Thursday of the first artificial ligament--a braided strand of synthetic fiber used to repair certain types of sports injuries--designed to enable an athlete to walk or run in a matter of weeks rather than six or eight months.
The artificial ligament attaches between the thigh and the lower leg bone to stabilize the knee after the natural ligament--called the anterior cruciate--is torn, a frequent occurrence in football, soccer and skiing.
The artificial ligament is made of expanded polytetrafluoroethylene, or Gore-Tex, a tough, durable material already used in sutures and blood vessel grafts, as well as in ski parkas, running clothes and foul-weather gear.
It has been used experimentally for two years on more than 1,000 patients at 27 hospitals in the United States.
The FDA said that many patients implanted with the device can walk and run within several weeks, compared to the six to eight months required after traditional surgery, in which a patient's tendon is grafted in place of the ligament. This procedure generally requires a long recovery period to enable the graft to grow strong and become firmly attached, the agency said.