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.
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.
