First Synthetic Cartilage Approved by FDA

Wow. The first week of July was a big week for FDA approvals for orthopedic devices.

On July 5, 2016, the FDA granted Premarket Approval (PMA) for the Cartiva, Inc.’s Synthetic Cartilage Implant (SCI) for arthritis of the big toe joint. The implant is the first synthetic cartilage device approved by the FDA.

The FDA’s 12-panel of orthopedic experts voted on April 20, 2016 to recommend approval of Cartiva Inc.’s device after determining the device was safe, effective and the benefits outweighed the risks to patients.

Cartiva SCI

Cartiva SCI, according to the company, is intended for the treatment of arthritis at the base of the big toe, the most common arthritic condition in the foot. The current standard of care involves fusing the bones in the arthritic joint with screws and plates. “While fusion is an effective procedure for eliminating pain, it permanently prevents movement of the joint, ” stated the company announcement.

Cartiva’s device is an alternative to fusion and is a biocompatible, biomedical polymer implant designed to have physical properties similar to those of articular cartilage. Damaged cartilage is replaced with a small Cartiva SCI implant that provides a cartilage-like compressible, low-friction and durable bearing surface. The implant provides pain relief and improves both function and motion.

The company said the FDA’s decision was based on a 236-patient, multi-center, prospective, randomized study comparing the device to fusion. It was the largest study ever conducted for this condition.

Clinical Evidence

According to the company, key findings from the Level I clinical study include:

• The Cartiva patient group demonstrated clinical success of 80% for the composite primary endpoint (pain, function and safety) at 24 months compared to 79% success for the fusion group
• Cartiva patients achieved a 93% reduction in median pain
• Cartiva patients demonstrated a 168% improvement in median function of sporting activities and 65% improvement in activities of daily living
• Cartiva patients experienced a 26% improvement in range of motion from baseline

The device has been approved for use outside the U.S. since 2002 and is currently available in Europe, Canada and Brazil. To date, more than 4, 000 implants have been used. It is performed in a simple outpatient procedure lasting approximately 35 minutes. Unlike a fusion procedure, patients may begin weight bearing immediately as tolerated.

Tim Patrick, Cartiva’s president and CEO, said the company will introduce the device at the American Orthopaedic Foot and Ankle Society Annual Meeting in Toronto later in July.