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A Novel Polymeric Percutaneous Heart Valve Prosthesis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HL104814-01
Agency Tracking Number: HL104814
Amount: $99,665.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PHS2010-2
Solicitation Year: 2010
Award Year: 2010
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
United States
DUNS: 050636737
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (978) 646-1684
Business Contact
Phone: (978) 777-5410
Research Institution

DESCRIPTION (provided by applicant): The objective of this SBIR program is the modification of a polymeric trileaflet heart valve to a valve prosthesis that can be delivered percutaneously as a transcatheter aortic valve replacement. Key innovations include improved durability and hemodynamic properties, lower manufacturing costs, and simplified delivery over existing transcatheter bioprosthetic valves. The polymeric valve is less susceptible to damage upon crimping, while the polyurethane material does not require glutaraldehyde fixation, unlike biological tissue. Abiomed has developed a solvent-cast polyurethane valve platform technology that has performed well in ventricular assist devices (VADs) and a total artificial heart (TAH) and is currently being evaluated as valve prosthesis for conventional open-chest surgical implantation. A prototype low-profile percutaneous valve was developed using Abiomed's proprietary polyurethane (Angioflexj). The specific aims of Phase I include: 1. Further Development of a Polymeric Percutaneous Valve Prototype: o Optimize attachment to either a self-expanding or balloon-expandable stent o Determine anchoring mechanism for secure implantation o Optimize valve incorporation with existing 18 F or less delivery catheter 2. In Vitro Evaluation: o Simulated placement testing o Hydrodynamic characterization o Commence accelerated life testing Phase II will incorporate feedback from the in vitro evaluation of the prototype device and subsequent animal studies will evaluate device delivery, validate valve fixation within the aortic annulus, assess paravalvular leakage, and assess valve clearance of coronary ostia and hemodynamic performance. Further animal studies will evaluate transcatheter deliverability using either a retrograde femoral approach for aortic placement or antegrade transapical approach for placement in the aortic or mitral valve position. Thromboresistance of the valve and supporting stent structure, and assessment valve durability relative to calcification or other physical degradation will be performed in Phase II. PUBLIC HEALTH RELEVANCE: We anticipate that improved durability and hemodynamic properties, and simplified delivery of a polymeric percutaneous valve will have significant advantages over existing percutaneous valves. We further anticipate a significant cost reduction when compared to existing percutaneous valves, while manufacturability in a wider range of clinically relevant diameters will be possible. Development of polymeric percutaneous valve technology in Phase I will permit in vivo evaluation in Phase II before proceeding to initial clinical studies. In summary, the valve proposed in this research will lead to a new generation of percutaneous heart valves that improves upon the shortcomings of existing valves, reduces the cost burden on the health care system and improves the standard of care for patients with valvular heart disease.

* Information listed above is at the time of submission. *

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