10.3 million Bioprosthetic heart valves (BHV) have been implanted since 1980 in the United States alone, but the solution for a durable, non-calcifying bioprosthesis still eludes us. High rates of structural failures and rapid calcificationin BHVs, has veered a gradual shift towards the development of polymeric heart valves (PHV). Biocompatible polymers are excellent materials for heart valves for their tunable mechanical properties (for improved durability), tunable surface properties (for reduced calcification), and the ability to program hemocompatibility (for non-thrombogenecity). Few polymeric materials have already been tested for heart valves, yet one that packages the three essential properties of durability, anti-calcific, and non-thrombogenic still remains to be developed. The intellectual merit of this STTR Phase I proposal is to develop a polymeric heart valve using a novel ultra-polymer, polyetheretherketone (PEEK), to fully address the essential properties for cardiovascular applications. This proposal will establish that PEEK may provide an ideal materials solution for artificial heart valves, for both surgical and transcatheter deploy-ability. The mechanical properties of PEEK are up to an order of magnitude higher than traditional polymers with excellent fatigue resistance, low water absorption, and highly inert structure. PEEK structures can be molded to shape, woven, and/or non-woven to avoid regions of stress concentration (where structural failure of BHV occurs), and are hemocompatible to avoid thrombosis. Furthermore, PEEK can be processed to demonstrate shape memory, which allows its use for transcatheter valve deploy-ability. In this application, we propose the testing of a PEEK heart valve for its hemodynamic ability, mechanical durability, thrombogenicity, and acute in vivo function in a swine model. To develop and translate the PEEK valve for clinical use, a committed academia-industry partnership is established between the heart valve research laboratory at Emory University, and a shape-memory polymer development company, MedShape Solutions Inc. Our team synergizes expertise and resources in heart valve development and testing at Emory University;and polymer innovation, processing and commercialization of FDA-approved polymeric devices at Medshape Solutions Inc.
The burden of valvular heart disease is significant in the United States, prevalent in 2.5% of the total population (8.75 million) and 13.3% of adults beyond 65 years of age (5.78 million) in 2011. Replacement of the diseased heart valves with man-made mechanical or bioprosthetic valves is a routine cardiac surgical procedure today, yet one which is plagued with high rates of failure due to the need for anti-coagulation therapy with mechanical valves and the rapid degeneration associated with bioprosthetic valves. In this application, we propose the development and testing of a novel polymeric heart valve, prepared from a resilient, highly durable material with exquisite shape memory properties.