Cartiva Announces Publication of Positive Data for Synthetic Cartilage Implant in the Treatment of Osteoarthritis of the Thumb
ALPHARETTA, Ga.--(BUSINESS WIRE)--Cartiva, Inc. (Company), a developer of innovative solutions for the treatment of cartilage damage and osteoarthritis, today announced the publication of a peer-reviewed article entitled “First metacarpal resurfacing with polyvinyl alcohol implant in rhizarthrosis: Preliminary study.” The study, which was published in the June 2014 issue of Chirurgie de la Main, demonstrated significant clinical improvement using Cartiva Synthetic Cartilage Implant (SCI) in patients with osteoarthritis of the first carpometacarpal (CMC) joint at the base of the thumb. Cartiva SCI is a proprietary polyvinyl alcohol (PVA) hydrogel that was designed to mimic natural cartilage.
“We are pleased with the early results from this preliminary study that indicate that Cartiva may fill the unmet need for a minimally aggressive procedure that preserves the anatomical structure of the joint.”
Osteoarthritis of the thumb is the most common site for osteoarthritis of the hand, affecting 8% to 12% of the general population and as many as 33% of postmenopausal women. Also known as basal thumb arthritis, osteoarthritis of the CMC joint causes pain, swelling, instability, deformity, loss of motion and weakness, making it difficult to perform simple household tasks, such as turning doorknobs and opening jars. Current surgical options for later-stage patients for whom conservative treatments have failed include joint fusion, total or partial trapeziectomy or arthroplasty.
The article reviews data at an average follow up of 30 months (range 23 to 44 months) on seven patients receiving a Cartiva SCI implant to resurface the base of the first metacarpal joint. The authors found grip and pinch strength were significantly improved, nearly full range of motion was achieved and the ability to perform daily activities was enhanced according to the Disabilities of the Arm, Shoulder and Hand (DASH) score assessment. No radiographic evidence of osteolysis or implant movement was observed at the last follow-up, nor were any instances of inflammatory reaction identified on MRI examination.
“Historically, surgical candidates have typically had two treatment options: salvage surgery, such as trapeziectomy, which produces good clinical outcomes but may result in a lengthy recovery and impaired pinch strength; and implant arthroplasty, which showed early promise but over the longer term has shown high incidences of complications such as particulate synovitis and implant loosening,” said Gustavo Mantovani Ruggiero, M.D., of the Beneficência Portuguesa de Sao Paulo Hospital in Sao Paulo, Brazil and senior author of the study. “We are pleased with the early results from this preliminary study that indicate that Cartiva may fill the unmet need for a minimally aggressive procedure that preserves the anatomical structure of the joint."
“Expanding the use of Cartiva into other joints by building on the MOTION study, the largest ever conducted for great-toe arthritis, is a natural progression for the Company,” said Timothy J. Patrick, president and CEO of the Company. “We are encouraged with the initial clinical results using Cartiva in the treatment of basal thumb arthritis, a debilitating condition affecting a significant portion of the population. We are making additional refinements to the implant that will allow us to treat a broader number of patients, and are looking forward to additional implants later this year.”
About Cartiva SCI
Cartiva® Synthetic Cartilage Implant (SCI) is intended to treat osteochondral defects of the articular cartilage surface associated with joint pain or decreased range of motion. Cartiva SCI is a proprietary polyvinyl alcohol (PVA) hydrogel that was designed to mimic natural cartilage. A patented manufacturing process enables Cartiva, Inc. to customize the PVA hydrogel to meet defined functional requirements. The physical properties of Cartiva SCI, including the water content, compressive properties and low coefficient of friction, are similar to natural cartilage. Along with its ability to withstand physiologic loading, the Cartiva implant’s properties make it an ideal design for the replacement of damaged articular surfaces. Additionally, relative to other alternatives, Cartiva SCI minimizes the amount of bone that needs to be removed from the patient. Cartiva SCI is implanted in a single procedure similar to that used for osteochondral autograft or allograft transplantation, by placing the device in a pre-drilled hole to resurface the damaged area of cartilage. Cartiva SCI is currently available in Canada, Europe and South America. Cartiva SCI is not available for sale or use in the United States.
Cartiva SCI is currently under clinical investigation in a 236-patient randomized pivotal study (the MOTION Study) to determine its safety and effectiveness compared to fusion for the treatment of osteoarthritis of the first metatarsophalangeal joint.
About Cartiva, Inc.
Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with osteoarthritis or cartilage damage. Additional information is available on the Company’s website at www.cartiva.net.