Boston Scientific Begins Phase III Trials of the Lotus Valve System
Boston Scientific Corporation said it has commenced a pivotal study to evaluate the safety and effectiveness of its Lotus Valve System, the REPRISE III clinical trial. The system is indicated for treating patients with severe aortic stenosis who are considered either high or extreme risk for surgical valve replacement.
The Lotus Valve System is the first transcatheter aortic valve replacement device that is both fully repositionable and retrievable prior to release, the Marlborough, Mass. devicemaker said.
The first three valves were implanted this week as part of the REPRISE III study. The initiation of this trial will begin the process of seeking FDA premarket approval, Boston Scientific said.
The randomized study will pit the Lotus Valve system against Medtronic’s CoreValve TAVR System. The safety endpoint will gauge mortality, stroke, life-threatening and major bleeding events, stage two or three acute kidney injury or major vascular complications at 30 days. The efficacy endpoint will study mortality, disabling stroke, or moderate or greater paravalvular aortic leaking at one year following the procedure, the devicemaker said.
The REPRISE I and II studies have demonstrated consistent safety and performance outcomes of the system, the company said. The Lotus Valve system is still an investigation device in the U.S., but is CE marked in the EU. — Kellen Owings
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