A Novel Fully-Polymeric, Biomimetic Prosthetic Mitral Valve Constructed from Clinically-Proven Materials to Improve Durability, Performance, and Overall Outcomes

PROJECT SUMMARY Although biologic valve leaflets are the gold-standard for surgical mitral valve replacement, there are well-known problems associated with valve durability, thrombosis, calcification, and immune response in surgical biologic valves and transcatheter valves1. While mechanical valves are capable of lasting significantly longer when compared with the biologic valve options, the significant drawback of anticoagulant requirements necessitate a valve that combines the positive characteristics of both biologic and mechanical valves in order to improve patient outcomes. PECA Labs has developed a novel mitral valve using a patented fluoropolymer formulation to create bio-inert, highly antithrombogenic leaflets with flexibility and bio-compatibility of biologic surgical mitral valves, the strength and resistance to wear of mechanical mitral valves, while being further bio-inert and anti- thrombogenic when compared with both. PECA Labs has also developed a biomimetic shaping technique that allows for the specialized polymer leaflets to feature improved hydrodynamic characteristics, including larger EOA and reduced regurgitation. PECA Labs has shown success with polymer leaflets used in a pulmonary valve that is currently in clinical trials within the US and has shown promising 6-month results. Specific Aim 1 of this study is to subject the polymer leaflet material to hydrodynamic performance and durability testing across multiple configurations to verify the material’s strength and movement properties. Hydrodynamic and accelerated wear testing will be completed based on ISO 5840 guidelines for three sizes of the proposed Mitral Valve. The valves will be subjected to 600 million cycles of accelerated wear testing with performance evaluations using a pulse duplicator every 50 million cycles at hypotensive, normotensive and hypertensive conditions to evaluate any wear and tear or hydrodynamic deficiencies. The valves will further be tested beyond the 200 million cycle mark (a benchmark set within the ISO5840) until the valves are completely destroyed to closely analyze the mechanisms of failure. Specific Aim 2 of this study is feasibility testing to verify the in vivo functionality of the material. Mitral Valves constructed with the novel polymeric, biomimetic material that is understood to be bio-inert and anti- thrombogenic will be evaluated in a chronic large animal model to evaluate in vivo hydrodynamic characteristics and allow for histopathologic evaluation of the valve for bio-inertness. This novel multi-layer fluoropolymer formulation with biomimetic shaping is expected to have significantly lower valve-surface thrombosis and is expected to further increase the longevity and functionality of the valve when compared to biologic leaflets. Thus, this study will illustrate that the use of the novel leaflets provides equivalent or improved physiologic and functional characteristics when compared with historical data on commercially-available biological valves in an in vivo setting.