Mechanically-expanding valve Lotus Edge was discontinued worldwide, as recently informed by its manufacturer, Boston Scientific. This is a voluntary recall of all Lotus valve inventory, and the immediate suspension of the program. The United States Food and Drug Administration (FDA) approved Lotus Edge in 2019 for patients with severe aortic stenosis and high surgical risk.…
Lotus Returns with New Strength and the FDA Approval to Compete with Sapien3 and CoreValve Evolut R
After reports of some serious adverse events with first-generation Lotus, the device was pulled off the market—but it was not meant to be left in oblivion. Now, it is back, renewed and with the approval of the United States Food and Drug Administration (FDA), to compete directly with the two market leaders (Sapien and CoreValve),…
Lotus Valve in Real Life Patients: the near total lack of leaks is its greatest strength
Even though the incidence of complications in transcatheter aortic valve replacement (TAVR) have significantly decreased, there is one in particular that remains a concern since, when mild, it is associated to increased events rate. This complication is prosthetic paravalvular leak , which happens between the native annulus and the stent. The Lotus valve, completely repositionable, uses a…
Lotus vs Sapien 3, different mechanisms with similar results
The new generation devices for transfemoral transcatheter aortic valve replacement have been optimized to improve valve position and reduce residual aortic regurgitation. This study compared 30 day, 12 month and 24 month outcomes of the repositionable, Lotus valve, with controlled mechanical expansion, and the balloon-expandable valve Edwards Sapien 3. Primary end point was all cause mortality…
REPRISE III: Lotus and CoreValve Compared in High-Risk or Inoperable Patients
The efficacy of transcatheter aortic valve replacement (TAVR) has been well-established. However, its limitations include suboptimal deployment and paravalvular leak. The Lotus system is a fully repositionable and retrievable device with controlled mechanical expansion. It features an adaptive seal to minimize paravalvular leak, it does not require early pacing during deployment, and, given its early…
One year outcomes of the new repositionable and retrievable valve
Original Title: 1-Year Outcomes with the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients with Severe Aortic Stenosis Results of the REPRISE II Study. Reference: Ian T. Meredith et al. J Am Coll Cardiol Intv. 2016;9(4):376-384. This analysis represents the first report at one year of 120 patients enrolled…