In a cohort of 106 patients from Cartiva's pivotal clinical trial followed out to 5.8 years, functional outcomes improved significantly, pain was reduced significantly, and Cartiva® demonstrated excellent durability and survivorship. Furthermore, patients maintained their great toe motion and were satisfied, with 93% of patients indicating they would undergo the procedure again.
The following tables demonstrate the now almost 6-year outcomes for Cartiva.
Cartiva patients have experienced nearly the same substantial reduction in pain as fusion patients, with durable results out to almost 6 years.
Cartiva patients demonstrate long-lasting, substantial improvement in foot function.
Pain relief, increased motion, and quicker recovery time mean happier patients.
The entire surgery only takes about 35 minutes.
The use of Cartiva does not prevent an easy revision to fusion in the future.
Significant pain reduction and functional improvement at almost six years.
The next generation instrumentation set with enhanced features from Cartiva® offers increased efficiences and cost savings for first MTP implant surgeries.
Off-the-shelf sterile set minimizes the risk for contamination.
The clear Introducer provides visual confirmation of implant placement during insertion. Markings give the ability to confirm proper implant orientation. Introducer tip fits into the cavity to provide enhanced stability during implant delivery.
Provides confirmation of cavity depth.
Off-the-shelf set improves operating room efficiencies. Sterile pre-packaged sets ensure instruments are ready for surgery when you are.
Single-use instruments minimize risk for contamination and save time and money spent on reprocessing.
Single-use instruments reduce storage space. The compact set is 88% lighter and 78% smaller than the reusable tray with instruments.
Color coded packaging provides easy identification of instrument size required for surgery. 8mm and 10mm pre-packaged sets available.
1 A substantial and clinically meaningful reduction in pain using the Visual Analog Scale (VAS) was experienced by Cartiva® patients at every follow-up visit through 5.8 years. Cartiva implant patients demonstrated a 97% reduction in pain from baseline out to 5.8 years.
2 Functional activities were evaluated using the validated Foot and Ankle Mobility Measure (FAAM). Substantial and clinically meaningful improvement was observed for the Cartiva implant subjects throughout the 5.8 year follow-up period with a 176% median improvement observed in the sporting activities scale.