CARTIVA®

6 year outcomes

Cartiva patients demonstrate long-lasting, substantial improvement in foot function.

Clinical Data

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.

97%

Reduction in Pain1

Cartiva patients have experienced nearly the same substantial reduction in pain as fusion patients.

Cartiva pain reduction data

Data on file at Cartiva, Inc. N=106 in post-approval study cohort; followed to a mean of 5.8 years.

176%

Functional Improvement2

Cartiva patients demonstrate long-lasting, substantial improvement in foot function.

Cartiva functional improvement data

Data on file at Cartiva, Inc. N=106 in post-approval study cohort; followed to a mean of 5.8 years.

The only product of its kind backed By Level I Clinical Evidence

The result of the largest clinical study of the MTP joint to date. The only FDA-approved alternative to fusion.

An Advanced Solution

Patient Satisfation

Pain relief, increased motion, and quicker recovery time mean happier patients.

40% Faster than Fusion

The entire Cartiva® surgery only takes about 35 minutes to complete.

Burns no Bridges

The use of Cartiva does not prevent the implementation of fusion in the future.

Proven Durability

Significant pain reduction and functional improvement at five years (N=27).*

 

Watch Implant Placement Single Use Instrumentation

 

* Daniels TR, Younger SE, Penner MJ, et al. Foot Ankle Int. 2017;38(3):243-247. Limited to five year data from a subset of study participants (N=27). Additional data from other sites and subjects not yet available.

Cartiva is an effective option for patients wishing to maintain their range of motion while getting significant pain relief.

Selene G. Parekh, MD, MBA, Prof of Orthopedic Surgery, Duke University

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Footnotes

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.

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