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The Leaflex™ Performer is an investigational device

European Union: CAUTION Exclusively for Clinical Investigation

Next Generation Valve Repair

Leaflex™ Characteristics

 

Non-Implant

Based

Designed to Score Calcifications Within Valve

Aimed to Increase Leaflets

Compliance –

Increase in

Aortic Valve Area

Innovative

Mechanism of Action –

No Recoil Effect

Non-Occlusive

No Rapid Pacing

Transfemoral

Low-Profile Catheter

Short

Procedure

Short

Hospitalization

Affordable

Solution

The Leaflex™ Performer

Device Overview

Scoring Mechanism

Scoring lines create separation between the calcium deposits on the two sides of the scoring line, in order to regain leaflets flexibility, allow their mobility and improve valve hemodynamics.

 

The Frame, including the scoring elements, is positioned on the aortic side of the valve.

The Expander, positioned below the valves, is pulled towards the frame pushing the leaflets against the Scoring Elements to create scoring lines in the calcium.