ALPHARETTA, Ga.--(BUSINESS WIRE)--Cartiva, Inc., a medical device company focused on the treatment of osteoarthritis of the extremities, announced the first U.S. patient has been treated in its GRIP 2 Study, a multi-center study evaluating the safety and effectiveness of Cartiva Synthetic Cartilage Implant (SCI) in the treatment of first carpometacarpal (CMC) joint osteoarthritis at the base of the thumb. Cartiva SCI is a proprietary hydrogel polymer device designed to mimic natural cartilage. Its physical properties, including water content, compressive properties and low coefficient of friction, are similar to natural cartilage. Cartiva SCI is implanted in the metacarpal base to replace damaged cartilage without destroying or removing healthy tissue. Cartiva SCI gained Food and Drug Administration (FDA) premarket approval for use in arthritis at the base of the big toe in July 2016.
Indianapolis orthopedic surgeon Greg Merrell, M.D., performed the surgery earlier this month on a 54 year old woman’s arthritic right thumb at the Indiana Hand to Shoulder Center. Dr. Merrell is a graduate of Yale Medical School and is Associate Editor for the Journal of Hand Surgery.
An earlier trial of Cartiva SCI for CMC arthritis, called GRIP, enrolled 50 patients at nine sites in Canada and the United Kingdom. An interim analysis reported on forty-four patients that had reached their one year follow-up. The average pain reduction was 68 percent as compared to published literature rates of 49 percent for ligament reconstruction and tendon interposition (LRTI) surgery1. Cartiva patients also saw significant improvements in hand strength, including grip strength, key pinch strength, and tip pinch strength.
Osteoarthritis of the thumb CMC joint is a common and frequently debilitating condition afflicting more than 20 million U.S. adults including an estimated one-fourth of postmenopausal women. Also known as basal joint arthritis, osteoarthritis of the CMC joint causes pain, swelling, instability, deformity, loss of motion and weakness, making it difficult to perform a variety of tasks, such as turning doorknobs and opening jars. Current surgical options for later-stage patients who have failed conservative treatments include joint fusion, trapeziectomy with or without LRTI, and arthroplasty.
The GRIP 2 study implant is used in the treatment of osteoarthritis in patients with diseased or damaged articular surface in the first CMC joint. Cartiva SCI, which is implanted in the base of the metacarpal, minimizes bone removal and preserves the trapezium bone at the thumb’s base which is critical to hand strength. Because this new procedure preserves normal joint anatomy, conventional surgical treatments remain an option if later required. The Cartiva implant for CMC is currently available in Europe and Canada.
“The Cartiva device was implanted in a straightforward and quick surgical procedure”, said Dr. Merrell. “The implant potentially offers advantages over existing procedures, most significantly with respect to improved hand strength. We look forward to building upon the impressive results of the initial GRIP feasibility study.”
“Treating the first U.S. CMC patient is another significant milestone for Cartiva,” said Tim Patrick, President and CEO. “We believe the results from this study will be similar to those from our feasibility study, demonstrating that Cartiva SCI can be an attractive options for patients suffering from this debilitating condition.”
About the GRIP 2 Study
The Grip 2 Study is a prospective study evaluating the safety and effectiveness of the Cartiva® Synthetic Cartilage Implant for CMC in the treatment of First Carpometacarpal Joint Osteoarthritis as compared to a ligament reconstruction tendon interposition (LRTI) comparator. An estimated 74 patients will be enrolled at sites in the United States and the United Kingdom. Additional information may be found at www.gripstudy.com.
About Cartiva, Inc.
Based in Alpharetta, Ga., Cartiva, Inc. is a medical device company focused on the treatment of osteoarthritis of the extremities. Cartiva’s synthetic cartilage is the only FDA-approved biomedical implant that mimics natural cartilage. The company’s venture investors include New Enterprise Associates and Windham Venture Partners. Additional information is available on the company’s website at www.cartiva.net.
1 Belcher HJ, Nicholl JE. A comparison of trapeziectomy with and without ligament reconstruction and tendon interposition. J Hand Surg Br. 2000 Aug;25(4):350-6.