DT MedTech Wednesday said it received premarket approval from FDA for its ankle replacement implant, the Hintermann Series H3 Total Ankle Replacement System.
The approval, which comes 19 years after H3 was authorized for sale outside of the U.S., was based on clinical data showing 96% of patients were at least moderately satisfied with the device five years after their procedures.
That data point, plus the 88% seven-year survival rate, underpins DT MedTech’s claims that the design of the device supports long-term stability and its efforts to compete with rivals such as Stryker and Zimmer Biomet.
Swiss Surgeon Beat Hintermann developed H3, formerly known as Hintegra, to improve on older implants used in total ankle replacement procedures. Physicians began performing such procedures decades ago but analyses of outcomes among patients treated in the 1970s and 1980s found poor long-term outcomes and high complication rates.
Second and third-generation devices, such as Depuy's Agility and Mobility, yielded better results, but Hintermann's design has a flat, anatomically-conforming component that contacts the resected area, whereas rival devices use intramedullary fixation. Hintermann says the H3 design provides better load transfer between the implants and bone, thereby improving the long-term stability of the component.
H3 came to market outside the U.S. in 2000, meaning DT MedTech had years of data on the device when it acquired the Hintermann portfolio in 2015.
DT MedTech secured 510(k) clearance for another Hintermann device, H2, in 2017 and has now used the long-term survival and patient satisfaction data on H3 to get approval for a second ankle system.
The company will continue to sell H2 alongside H3 in the U.S. Many of the instruments used in the H2 and H3 procedures are the same, which Hintermann said will enable physicians to decide on which device to use after starting the procedure. H2 has some of the same components as H3 but features design tweaks intended to protect the ligaments from overloading.