LOTUS Edge™

Aortic Valve System

Surgical-Like PVL

Stable Delivery

100% Repositionable

LOTUS Clinical Overview

reprise-trial

LOTUS Edge has a braided nitinol frame and Adaptive Seal™ Technology that conform to patients’ anatomies, virtually eliminating paravalvular leak.

LOTUS Edge features exclusive deployment technology designed to offer complete control and stable deployment without valve migration.

LOTUS Edge offers a new, flexible catheter for improved trackability.

Watch an animation of the LOTUS Edge implantation procedure and see how it was designed to offer complete control and predictable results.

LOTUS Edge has a braided nitinol frame and Adaptive Seal™ Technology that conform to patients’ anatomies, virtually eliminating paravalvular leak.

LOTUS Edge features exclusive deployment technology designed to offer complete control and stable deployment without valve migration.

LOTUS Edge offers a new, flexible catheter for improved trackability.

Watch an animation of the LOTUS Edge implantation procedure and see how it was designed to offer complete control and predictable results.

When Complete Control Matters, LOTUS Edge Delivers

The LOTUS Edge Aortic Valve System is a next-generation, controlled expansion TAVR valve designed to provide unmatched freedom from paravalvular leak (PVL), precise delivery with the ability to reposition after deployment, and predictable results.

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Product Details

Adaptive Seal Technology
Conforms to patients’ anatomies to create a secure seal, virtually eliminating paravalvular leak (PVL).

Braided Nitinol Frame
Designed for strength, flexibility and the ability to retrieve, reposition and redeploy.

Exclusive Deployment Technology
Enables complete control and stable deployment for precise placement and reduced procedural complications.

100% Repositionable
The only 100% repositionable TAVR valve that allows you to assess final valve position and function after deployment with the option to recapture and reposition prior to release for optimal outcomes every time.

Flexible Catheter
A new, flexible catheter that improves trackability.

Depth Guard™
Proprietary Depth Guard technology is designed to reduce left ventricular outflow tract (LVOT) interaction and permanent pacemaker (PPM) rates by minimizing the depth of the valve during deployment.

One View Locking
Additional radiopaque markers enable the operator to confirm locking in one view.

Bovine Pericardium
Proven long-term material designed for lasting results.

Valve Specifications

	23 mm	25 mm	27 mm
Native Annulus Diameter*	≥ 20 mm & ≤ 23 mm	≥ 23 mm & ≤ 25 mm	≥ 25 mm & ≤ 27 mm
Delpoyed LOTUS Edge Valve OD	23 mm	25 mm	27 mm
Deployed Valve Height	19 mm	19 mm	19 mm

*As measured by baseline diagnostic imaging.

Clinical Information

The LOTUS Valve platform has demonstrated superior outcomes in clinical studies of approximately 2,000 patients at 160 sites around the world. Enrollment for the REPRISE IV trial began in 2019 to evaluate outcomes with LOTUS Edge in patients at intermediate surgical risk, including those with a native bicuspid valve.

LOTUS Valve Platform Clinical Program

* LOTUS (N = 607); CoreValve™ (N = 305)

Surgical-Like PVL

Learn how our unique Adaptive Seal and braided valve frame conform to each patient’s anatomy, virtually eliminating paravalvular leak.

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.

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