FoldaValve

 Ingenuity in action

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.