FDA approved Lotus Edge for transcatheter aortic valve replacement (TAVR) in severe aortic stenosis patients considered high risk for open heart surgery, Boston Scientific , completing a difficult route to market.
Lotus joins the Sapien and CoreValve/Evolut families of TAVR devices in that indication. It is unique in being repositionable and retrievable after full deployment.
It also features a braided valve frame and an adaptive seal designed to minimize paravalvular regurgitation or leak.
FDA approval was based on findings from the pivotal REPRISE trial in more than 1,000 patients. In 1-year results, Lotus beat CoreValve on the composite of all-cause death, disabling stroke, and moderate-or-worse paravalvular leak (16.7% vs 29.0%, P<0.001). But it also had a higher 30-day new pacemaker rate compared with the CoreValve group (35.5% vs 19.6%, P<0.001).
At 2 years, overall efficacy results were similar, albeit with a new permanent pacemaker implantation rate of 41.7% for Lotus versus 26.1%, and more valve thrombosis (3.0% vs 0.0%).
The device has been delayed several times on the way to the U.S. market and recalled from the European market over issues with the pin connecting the device to its delivery system and design tweaks to alleviate the high pacemaker rate.
A fourth competitor in the TAVR space, the JenaValve, is in a .