Survival with Aortic Stenosis (AS) is Determined by Progression of Calcification (1)
Calcium Limits Valve Opening
Leaflets open along natural folding lines. The leaflets’ mobility is significantly compromised when calcium grows across these defined lines.
Leaflet's natural folding lines (A, dashed lines)
Calcium patterns cross leaflet's folding lines (B)
The Leaflex™ Performer
Next Generation Aortic Valve Repair
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
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)
(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 law to Investigational Use.
The Leaflex™ Performer is to be used exclusively for clinical investigations.