FoldaValve

Ingenuity in action

Deployment steps - collapsed to expanded

FoldaValve is a self-expandable transcatheter aortic valve with a delivery size of ~14-Fr that does not stent-crimp the leaflets.

FoldaValve is repositionable, retrievable and is transfemorally implantable.

This video shows the delivery and implantation of FoldaValve in an ovine model.

For more videos, please visit: https://goo.gl/kky9Bf

FOLDAVALVE TECHNOLOGY

FoldaValve is implanted with a unique delivery catheter (Ingenuity) that allows repositioning in six degrees-of-freedom when the valve is fully formed, minimizing leaks due to malpositioning. Ingenuity also allows retrieval if the implantation is unsuccessful.

FoldaValve™ uses a unique patented draw-string mechanism to deploy the valve in situ. Via this mechanism, the leaflets are spared from being stent-crimped during delivery, preserving their quality to an extent comparable to surgical valves.

FoldaValve™ has the smallest profile (14Fr OD) when compared to existing TAVRs.

FoldaValve’s intra-annular design minimizes the chance of conduction abnormalities, and has an outer skirt to prevent paravalvular leakage.

Side, top, and isometric views of FoldaValve.

CURRENT STATUS

This technology has been originally funded by the Wallace H. Coulter Foundation as well as a seed grant from NIH ICTS (UL1 TR000153)
The valves have surpassed 200M cycles in accelerated wear tests
Currently planning for acute first-in-man studies

CURRENT PLANS

Perform and document FDA-required in vitro tests
Acute Human Clinical Trial
GLP Chronic Animal Studies
Standardizing manufacturing and sterilization

Formation of FoldaValve.

IP PROTECTION

Patents #7,331,991, 7,780,724, 8,133,270, 8,702,788 and 8,348,999 describe FoldaValve™, and patents #9,744,037 and 9,668,859 describe FoldaValve’s delivery system, Ingenuity™.

Comparison between FoldaValve and other valves currently in the market.

FoldaValve is a self-expandable transcatheter aortic valve with a delivery size of ~14-Fr that does not stent-crimp the leaflets. FoldaValve is repositionable, retrievable and is transfemorally implantable.