The FDA’s Orthopaedic and Rehabilitation Devices Panel will meet on April 20, 2016 to discuss, make recommendations, and vote on the premarket approval application (PMA) for the Cartiva Synthetic Cartilage Implant (SCI), sponsored by Cartiva, Inc.
FDA Ortho Panel to Vote on Cartiva Synthetic Cartilage Implant
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Cartiva’s implant is an organic polymer-based biomaterial to mimic biologic cartilage. The device, according to an FDA announcement, is to be indicated for treatment of degenerative and post-traumatic arthritis in the first metatarsophalangeal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsophalangeal joint.
The FDA intends to make background material available to the public no later than two business days before the meeting.
The meeting will be held on Wednesday, April 20, 2016, from 8 a.m. to 6 p.m. at the Hilton Washington, DC/North, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, Maryland.
Last May we reported that the company submitted the final module for its PMA. The module covered the clinical results from the motion trial that evaluated the safety and effectiveness of Cartiva CI for the treatment of osteoarthritis at the base of the great toe.
The study involved the enrollment of 236 patients at 12 centers in Canada and the United Kingdom. The trial was designed to determine the safety and efficacy of Cartiva SCI in comparison to arthrodesis (fusion) for reducing the debilitating pain associated with osteoarthritis in the great toe. Patients were randomized 2:1 to either Cartiva SCI or arthrodesis. The primary endpoint for the trial was a composite evaluation of pain, function and safety.
Cartiva’s President and CEO Tim Patrick said, “This is the largest and most rigorous FDA trial ever completed for this clinical condition. We look forward to working with FDA to bring the first synthetic cartilage product to market.”
According to the company, Cartiva SCI is comprised of a proprietary polyvinyl alcohol (PVA) hydrogel designed to mimic natural cartilage. PVA is a synthetic polymer prepared by the hydrolysis of polyvinyl acetate and has been used in medical device applications for over 20 years. Cartiva customizes the PVA hydrogel to meet defined functional requirements. Cartiva officials state that the physical properties of Cartiva SCI, including the water content, compressive properties and low coefficient of friction, are similar to natural cartilage.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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