DT MedTech, LLC reports that the Hintermann Series H3™ Total Ankle Replacement (TAR) System has received premarket approval (PMA) from the U.S. Food and Drug Administration. The H3™ Total Ankle Replacement System is a three-piece, mobile-bearing implant. The Hintermann Series H3 Total Ankle Replacement System is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis or arthritis secondary to inflammatory disease.
The Hintermann Series H3™ Total Ankle Replacement System was developed by Prof. Dr. Beat Hintermann, a world-renowned foot and ankle surgeon based in Liestal, Switzerland. The H3 has been implanted in more than 20,000 patients outside of the U.S. since its first release in May 2000.
Prof. Dr. Hintermann, stated, “I am very proud of this achievement. Since implanting the first H3, it has been a dream to bring the H3 to the U.S. market and enhance patient care and outcomes. We have seen stellar H3 results outside of the U.S. and look forward to now being able to provide American surgeons with this TAR.”
According to the FDA’s Summary of Safety and Effectiveness Data, the clinical data used to support the PMA showed that 95.9% of Hintermann Series H3™ Total Ankle Replacement System patients were moderately satisfied to very satisfied with the procedure at five years post-implantation, and survivorship of 88% at 7 years.
David Reicher, President and Chief Executive Officer of DTM, stated, “We are extremely pleased to have received this approval for the H3. I want to thank Dr. Beat Hintermann and his team, everyone at M Squared Associates, our advisors and key stakeholders, and all of our Data Trace employees for their perseverance and tireless work in achieving this momentous goal.”
In addition to the H3, mobile-bearing TAR, DTM will continue selling the Hintermann Series H2® (H2), a two-piece, cemented, semi-constrained TAR which received 510(k) clearance to market in November 2017. Surgeons will now have an opportunity, using a single instrument set, to offer a full solution to their patients using the H3 or H2 to perform primary TAR.