LOTUS Edge™

Aortic Valve System

Surgical-Like PVL

Stable Delivery

100% Repositionable

LOTUS Clinical Overview

reprise-trial

Surgical-Like PVL

Designed to help physicians achieve surgical-like paravalvular leak (PVL) rates, the LOTUS Edge Aortic Valve System demonstrates best-in-class PVL across studies.

Adaptive Seal™ Technology: A unique multi-layer, multi-polymer seal creates a secure seal against the annulus, virtually eliminating PVL.

Braided Nitinol Frame: Designed for strength, flexibility and repositionability, the braided nitinol frame conforms to irregular patient anatomies to help prevent PVL.

Accessories

LOTUS Introducer Set SAFARI²™ Pre-Shaped TAVR Guidewire

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Directions for Use

Indications, Safety and Warnings

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REPRISE III: 1-Year PVL Rates

None/Trace PVL

Mild PVL

Moderate or Greater PVL

PVL Rates Across Studies

The LOTUS™ Valve has consistently demonstrated surgical-like paravalvular leak rates in clinical studies. The latest data presented on LOTUS Edge show a 97.1% rate of none/trace PVL at one year.

1. Blackman D., MD. Thirty-day outcomes in patients treated with a repositionable and fully retrievable aortic valve designed to reduce the incidence of conduction disturbances (RESPOND Extension study); EuroPCR 2017; Paris, France.
2. Walters D., MD. First Report of Clinical Outcomes with the Next-Generation LOTUS Edge Valve System: Results from the LOTUS Edge Feasibility Trial; ACC 2017; Washington, DC.
3. Meredith I., MD. Two-year outcomes with a fully repositionable and retrievable percutaneous aortic valve in 250 high surgical risk patients: Results from the REPRISE II trial extended cohort; PCRLV 2016; London, United Kingdom.
4. Van Meighem, N., MD. The RESPOND Study at One-Year: Primary Endpoint Outcomes with a Repositionable and Fully Retrievable Aortic Valve in Routine Clinical Practice; EuroPCR 2017; Paris, France.
5. Feldman T, MD. A Prospective, Randomised Investigation of a Novel Transcatheter Aortic Valve Implantation System: The REPRISE III Trial; EuroPCR 2017; Paris, France.
6. Götberg M., MD. One-year outcomes with the transcatheter LOTUS Edge Aortic Valve System; PCRLV 2018; London, United Kingdom.

Significantly Lower PVL Rates

Compared to Evolut™ R/CoreValve™, the LOTUS Valve platform demonstrated significantly lower paravalvular leak rates at 30 days and 1 year in REPRISE III.

≥ Mild PVL at 30 Days

P < 0.0001*

≥ Moderate PVL at 1 Year

P < 0.0001

* Includes comparison of number of patients with mild PVL [P < 0.0001] and patients with moderate or greater PVL [P < 0.0001] treated with LOTUS vs. Evolut R/CoreValve.

Asch F, Mani V, Singh A, et al. Hemodynamic and Echocardiographic Comparison of the Lotus and CoreValve Transcatheter Aortic Valves in Patients With High and Extreme Surgical Risk: An Analysis From the REPRISE III Randomized Controlled Trial. Circulation AHA. 2018;118.034129, originally published March 12, 2018.

PVL in Patients with High Calcium Burden

In the REPRISE III Clinical Trial, the LOTUS Valve platform had significantly lower paravalvular leak rates in patients with high calcium burden than Evolut R/CoreValve. This data is consistent with the superior PVL performance of LOTUS in the broader REPRISE III Trial.

Makkar R., MD. The impact of calcium burden on clinical outcomes and paravalvular regurgitation in the REPRISE III randomised controlled clinical trial; PCRLV 2017; London, United Kingdom.

Stable Delivery

Discover how our exclusive deployment technology was designed to provide complete control, precise placement and stable deployment.

100% Repositionable

Find out how LOTUS Edge enables you to assess final valve position after 100% deployment with the option to recapture and reposition.

Clinical Outcomes

Explore the clinical data showing superior paravalvular leak, stroke and procedural outcomes for the LOTUS Edge Aortic Valve System.

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