Cartiva, a developer of innovative products for the treatment of cartilage damage and osteoarthritis, has announced that it has received premarket approval (PMA) from the US Food and Drug Administration (FDA) for its synthetic implant for arthritis of the big toe joint. The approval allows the company to begin marketing in the United States the first synthetic cartilage device approved by the FDA.
Cartiva Synthetic Cartilage Implant (SCI) is intended for the treatment of arthritis at the base of the big toe, the most common arthritic condition in the foot. 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.
The Cartiva SCI device, an alternative to fusion, is a biocompatible, biomedical polymer implant designed to have physical properties similar to those of articular cartilage. Damaged cartilage is replaced with a small Cartiva SCI implant that provides a cartilage-like, compressible, low-friction and durable bearing surface. The implant provides pain relief and improves both function and motion.
The FDA’s decision was supported by the MOTION clinical study, a 236-patient, multi-centre, prospective, randomised study comparing Cartiva SCI with fusion – the largest study ever conducted for this condition.
Key findings from the Level I clinical study include:
The Cartiva patient group demonstrated clinical success of 80 per cent for the composite primary endpoint (pain, function and safety) at 24 months, compared with 79 per cent success for the fusion group.
Patients achieved a 93 per cent reduction in median pain.
Cartiva patients demonstrated a 168 per cent improvement in median function of sporting activities and 65 per cent improvement in activities of daily living.
Cartiva patients experienced a 26 per cent improvement in range of motion from baseline.
“The landmark MOTION study clearly shows Cartiva SCI to be a safe and effective alternative to fusion for patients wishing to maintain motion in their great toe,” said Judith Baumhauer, associate chair of academic affairs at the University of Rochester Medical Center and principal investigator on the MOTION study. “Based on these compelling results, I have eagerly awaited the FDA approval and the ability to offer this treatment option to my patients.”
Cartiva SCI has been approved for use outside the USA since 2002 and is currently available in Europe, Canada and Brazil. To date, more than 4000 implants have been used. It is performed in a simple outpatient procedure lasting approximately 35 minutes. Unlike a fusion procedure, patients may begin weightbearing immediately as tolerated.
“Before Cartiva SCI, the options we could provide to patients with osteoarthritis of the great toe were limited, as the fusion procedure often necessitates sacrificing range of motion to get pain relief,” said Mark Glazebrook of the Queen Elizabeth II Health Sciences Centre in Halifax, Nova Scotia, who uses Cartiva SCI in his practice. “Due to the simplicity of the procedure, speed of recovery and range of motion benefits, I see that patients are relieved to have this option available to them and the majority are electing Cartiva over fusion.”