Lotus Edge Gets FDA Approval for TAVR in High-risk Patients

Patrice Wendling

April 24, 2019

The US Food and Drug Administration (FDA) has approved the Lotus Edge aortic valve system for transcatheter delivery in patients with severe aortic stenosis at high risk for surgical aortic valve replacement.

The LOTUS Edge is the only FDA-approved aortic valve that gives physicians the option to reposition and completely recapture the valve once it has been fully deployed, Boston Scientific said in release yesterday announcing the approval.

It also features a braided valve frame and an adaptive seal that minimizes paravalvular regurgitation or leaking (PVL) by conforming to the patient's native aortic valve, they note.

The company did a "controlled launch" of the Lotus value in March in Europe and expects to begin a similar launch in the United States in the coming weeks. The Lotus valve is approved in Europe but underwent a voluntary recall because of premature release of a pin connecting the valve to the delivery system.

Approval in the United States was based on the REPRISE 3 data in high-risk patients, the first head-to-head comparison of two transcatheter aortic valve replacement (TAVR) valves.

As previously reported, the primary safety end point — a composite of all-cause mortality, stroke, life-threatening/major bleeding, stage 2/3 acute kidney injury, and major vascular complications at 30 days — occurred in 20.3% of 576 patients implanted with the Lotus valve and in 17.2% of 297 patients implanted with Medtronic's self-expanding CoreValve Classic or Evolut R valves (noninferiority = .003).

It was noted, however, that the end point failed to account for pacemaker implants, which were roughly double with the Lotus valve, whether measured as any new pacemaker (29.1% vs 15.8%) or in patients with no previous pacemaker (35.5% vs 19.6%; < .001 for both).

The next-generation Lotus valve has been reengineered to shorten it from the top down, and early experience shows pacemaker rates have fallen to below 20%, the investigators said at the time.

The primary efficacy end point — a composite of all-cause death, disabling stroke, and moderate or greater PVL at 1 year — with the Lotus was superior to the CoreValve in intention-to-treat (16.7% vs 29%) and as-treated (16.4% vs 28.6%; < .001 for both) analyses.

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