Technology:

LeaflexPerformer

 

Survival with Aortic Stenosis (AS) is Determined by Progression of Calcification (1)

Aortic Stenosis

Normal

Aortic Valve

Aortic Valve 

with Stenosis

Restricted

Blood Flow

heart.jpg
restricted blood flow.jpg
valve with aortic stenosis.jpg
healthy valve.jpg

Calcium Limits Valve Opening

Leaflets open along natural folding lines.  The leaflets’ mobility is significantly compromised when calcium grows across these defined lines.

A

B

Leaflet's natural folding lines (A, dashed lines)

Calcium patterns cross leaflet's folding lines (B)

The Leaflex™ Performer

Next Generation Aortic Valve Repair

PRE

POST

Standalone non-implant based transfemoral catheter solution for aortic stenosis

Modifies leaflet calcification to increase mobility and significantly improves flow through the valve

Safe, simple, controlled procedure

Affordable solution with short hospitalisation will encourage penetration in all markets

The Leaflex™ Procedure

Scoring Allows for Leaflet Mobility to be Regained

Finite Elements Analysis 

The aortic valve was modeled using Finite Elements Analysis. 

 

Typical calcification patterns were modeled on a hyperelastic valve tissue model, representing the mechanical behaviour of calcified leaflet.

The analysis guided the Leaflex™ design to define optimal scoring location and maximal treatment efficacy. (2)

Bridge Calcium Pattern

Without Scoring 

Scoring Calcium Pattern in Bridge

Bases and Centerline

Scoring Mechanism Designed to Improve Valve Function

Bench tests, using ex-vivo reconstructed human valves, further indicates that creating scoring lines within the natural folding lines of the leaflet is potentially effective for increasing leaflets' pliability, and thus may increase and improve the valve opening area. (2)

New Valve 1.jpg
New Valve 2.jpg

(1) Bhattacharyya et al. Controversies in cardiovascular medicine, Risk stratification in asymptomatic severe aortic stenosis: a critical appraisal. European Heart Journal, July 5, 2012. (2) Data available on file at Pi-Cardia.

CAUTION Investigational device. Limited by Federal lay to Investigational Use. 

The Leaflex™ Performer is to be used exclusively for clinical investigations.