Cartiva, Inc. announced today that the first commercial U.S. patient has received the Cartiva Synthetic Cartilage Implant (SCI) following its approval by the U.S. Food and Drug Administration (FDA) on July 1. The Cartiva SCI device is intended for use in the treatment of patients with painful arthritis at the base of the big toe, the most common arthritic condition in the foot. The outpatient procedure was performed by Dr. Judith F. Baumhauer at University of Rochester Medical Center’s Sawgrass Surgery Center.
The first synthetic cartilage device approved by the FDA, Cartiva provides another option for millions of patients who suffer from arthritis of the big toe joint. 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. During the Cartiva procedure, the damaged cartilage is removed and replaced with Cartiva SCI, a biocompatible, biomedical polymer implant, providing a cartilage-like, compressible, low-friction and durable bearing surface. Unlike a fusion procedure, patients may begin weight bearing immediately as tolerated.
“Today, one in 40 Americans over the age of 50 experience arthritis of the toe, and with the aging population, that number is likely to grow. This condition can be particularly life-impacting – limiting a person’s ability to conduct functional activities of daily living, producing pain and discomfort and restricting shoe wear options,” Dr. Baumhauer said. “The Cartiva implant was accomplished in a quick, simple surgical procedure and we look forward to offering this innovative option to more people in need.”