The US Food and Drug Administration has approved the Lotus Edge aortic valve system for transcatheter aortic valve replacement in patients at high risk for surgery, bringing—at long last—a third commercial player, Boston Scientific, into this space.
The approval, announced late yesterday, follows a “controlled launch” of Lotus Edge in Europe last month. The device was actually cleared in Europe back in September 2016, but later voluntarily withdrawn due to a faulty pin in the its delivery system.
Support for the FDA decision comes from the REPRISE III results, which featured the earlier-generation Lotus device but also included a nested registry of Lotus Edge recipients. REPRISE III results, presented at the EuroPCR 2017 meeting and reported by TCTMD, showed that the Lotus system was noninferior to a mixed population of CoreValve first-generation and Evolut R self-expanding valves (Medtronic).
Critics of the new valve have pointed out that the Lotus device has been associated with a high rate of pacemaker implantation—a problem the company has attempted to address with the innovation of a “depth guard” used during implantation. The guard allows for earlier anchoring and limits the depth of the implant to prevent interaction with the left ventricular outflow tract.
When 2-year outcomes for REPRISE III, published earlier this year, co-principal investigator Michael Reardon, MD (Houston Methodist DeBakey Heart and Vascular Center, TX), observed: “There are a lot of things that are pointing towards this being a really great third addition to the market. It’s also still the only valve that can be fully deployed and then evaluated. Then if you like it you can release it, if you don’t like it you can actually recapture it, remove it, change position.”