The Only Product of Its Kind Backed By Level I Clinical Evidence

The result of the largest, longest multi-center randomized clinical study of the MTP joint to date. The only FDA-approved alternative to fusion.

Clinical Data

6-year outcomes for Cartiva®

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, with durable results out to almost 6 years.

Pain chart
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.

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

An Advanced Solution

icon: patient satisfaction
Greater Patient
Satisfation

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

icon: fast
40% Faster
than Fusion

The entire surgery only takes about 35 minutes.

icon: burns no bridges
Burns no
Bridges

The use of Cartiva does not prevent an easy revision to fusion in the future.

icon: durable
Proven
Durability

Significant pain reduction and functional improvement at almost six years.

The Difference is Clear.

Introducing new single-use instrumentation

The next generation instrumentation set with enhanced features offers increased efficiences and cost savings for first MTP implant surgeries.

Single use callout

Single use callout

Placer

Allows surgeon to target optimal implant position to address worst area of wear.

Depth gauge to provide
confirmation of cavity depth.

Placement Guide Pin

2.0 mm non threaded.

Instrumentation

Specific to the size of the device (8 mm or 10 mm) being implanted.

Introducer

Compresses Cartiva prior to implantation.

Clear to allow visualization of implant during insertion.

No fixation required.

Metatarsal Drill Bit

Stop to ensure proper height of press-fit implant.

10mm tray

Off-the-shelf sterile set minimizes the risk for contamination.

Enhanced Visualization

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.

New Cavity Depth Gauge

Provides confirmation of cavity depth.

Cost Savings

Off-the-shelf set improves operating room efficiencies. Sterile pre-packaged sets ensure instruments are ready for surgery when you are.

No Sterilization/Reprocessing Costs

Single-use instruments minimize risk for contamination and save time and money spent on reprocessing.

Smaller Footprint

Single-use instruments reduce storage space. The compact set is 88% lighter and 78% smaller than the reusable tray with instruments.

Easy Instrument Identification

Color coded packaging provides easy identification of instrument size required for surgery. 8mm and 10mm pre-packaged sets available.

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Footnotes

1 A substantial and clinically meaningful reduction in pain using the Visual Analog Scale (VAS) was observed for Cartiva® patients at 5.8 years. Cartiva implant patients demonstrated a 97% median reduction in pain from baseline out to 5.8 years.

2 Functional activities were evaluated using the validated Foot and Ankle Mobility Measure (FAAM). A substantial and clinically meaningful improvement was observed in the median FAAM sports score at the 5.8 year follow-up with Cartiva patients reporting a 176% median improvement in the sporting activities score.