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Home >  News >  July, 2016

FDA Approves Synthetic Cartilage Implant Used to Treat Foot Pain

The Cartiva device improves function and range of motion for osteoarthritis patients.

Published: July 7, 2016

QUICK PROCEDURE Implanting the device takes about 35 minutes and is performed on an outpatient basis.

The FDA has granted premarket approval to the Cartiva Synthetic Cartilage Implant, which is used to treat osteoarthritis of the first metatarsophalangeal joint. It's the first synthetic cartilage device approved by the FDA.

A molded cylindrical device, the Cartiva SCI is implanted into the metatarsal head in the first MTP joint via press-fit implantation. The procedure takes about 35 minutes and is performed on an outpatient basis. Implant patients can begin weight-bearing immediately, unlike those who have fusion therapy, the current standard of care.

Approval was based on a 236-patient, multicenter, prospective, randomized study. The implant group had clinical success of 80% for the composite primary endpoint of pain, function and safety at 24 months, versus 79% success for the fusion group, according to the company.

The implant group also had a 93% reduction in median pain, a 168% improvement in median function during sporting activities, a 65% improvement in activities of daily living and a 26% improvement in range of motion.

Jim Burger


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