DT MedTech said yesterday that it won FDA premarket approval for its Hintermann Series H3 total ankle replacement system.
The Baltimore-based company said that its H3 system is a three-piece, mobile-bearing implant that is indicated for use as a non-cemented implant intended to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis or arthritis secondary to inflammatory disease.
The company said that, according to the FDA’s Summary of Safety and Effectiveness Data, clinical data used to support the PMA showed that 95.9% of H3 patients were moderately to very satisfied with the procedure at five years post-implant, as well as a suvivorship rate of 88% at seven years.
The H3 was originally released outside the U.S. in May 2000, and has been implanted in more than 20,000 patients, DT Medtech said.
“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,” device inventor Dr. Beat Hintermann said in a prepared statement.
DT Medtech acquired the Hintermann lower extremities assets, including the H3 total ankle replacement and revision system and the Kalix II implant designed to treat flat-foot deformities, in March 2016.
“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,” prez & CEO David Reicher said in a press release.