Cartiva said today that the FDA’s Orthopaedic and Rehabilitation Devices Panel voted in favor of the company’s synthetic cartilage implant for treating osteoarthritis at the base of the big toe.
The panel voted 10 to 2 in favor of the safety of the implant and 9 to 3 in favor of the efficacy of the implant. The panel also voted 8 to 2, with 2 abstentions, that the benefits of the implant outweighed the risks, Alpharetta, Ga.-based Cartiva said.
“We are extremely pleased with the positive results of the panel vote, which is one of the final milestones towards the commercialization of Cartiva in the United States. We thank the panel members for their insights and will continue to work with the FDA to make Cartiva SCI available to patients in the United States,” CEO Timothy Patrick said in prepared remarks.
The company said that the panel made the recommendations based on results from a 236-patient prospective and randomized clinical trial. The FDA will not be bound by the recommendation, but will take it into consideration when reviewing Cartiva’s Premarket Approval application.
Cartiva said it expects a final decision on the PMA later this year.
In February, The FDA set dates with Cartiva to review premarket approval applications for Cartiva’s Synthetic Cartilage Implant. Cartiva said the FDA recently inspected its home-based facility without any issues, as no observations were noted and no Form 483 was filed during the 5-day inspection.