ReValve Med, Inc. — Department of Health and Human Services SBIR Phase I: NHLBI

Description

Our long term goal is to develop and commercialize a replaceable transcatheter aortic valve TAV which is initially deployed with a covered base anchored within native diseased aortic valve without paravalvular leakage and a separate modular valve component inside the base Years later after transcatheter aortic valve replacement TAVR degenerates and fails the modular valve component can be retrieved and replaced with another valve component via transcatheter approach with a temporary valve Goal of Phase I SBIR is to develop two component TAV with base and replaceable valve and demonstrate retrievability of valve after implantation and release within the base To date no TAV on the market or in development has demonstrated this key step of retrieval after TAVR deployment Success of Phase I would lead to Phase II where we would demonstrate modular valve component replacement using a temporary valve for hemodynamic stability during deployment TAVR revolutionized treatment of severe aortic stenosis AS Randomized clinical trials proved TAVR improved survival over medical therapy for inoperable patients making TAVR the gold standard therapy Transfemoral TAVR also showed equivalent or superior outcomes when compared to surgical aortic valve replacement for high risk and now intermediate risk patients Large randomized trials are currently underway for low risk surgical patients with small studies showing TAVR and SAVR equivalence As TAVR expands to younger less risky patients durability becomes TAVRandapos s Achilles heel Alarmingly new TAVR durability data presented at EuroPCR May showed early TAVR degeneration within years with degeneration at years As TAVR expands to surgical patients s years old a clinical unmet need has emerged to develop TAVR devices with replaceability as an option We hypothesize that expanding TAVR to younger low risk surgical patients will require a replaceable TAV to overcome limited TAVR durability Our innovative solution is to develop a replaceable TAVR using a component modular system a permanent hollow covered base with a removable valve component that can be replaced Current rd generation TAVR have the ability to retrieve and reposition the valve for precise positioning during the implantation but once released none of the current designs allow for removability and replacement Our goal here is to demonstrate removability of TAVR valve component once fully released We propose following aims Test a two component TAVR prototype with fully retrievable removable valve component and implant in vitro in pulse duplicator to assess hemodynamics Demonstrate TAVR valve component repositionability then full release from delivery system Demonstrate TAVR valve component retrievability and removability by the retrieval system after full release of the TAVR Phase I SBIR is the first step towards offering younger healthier patients a removable and replaceable TAV Our Phase II goals will be developing delivery systems with embedded temporary valve for hemodynamic stability and filters to capture embolic debris during TAVR valve removal and reimplantation Over patients worldwide undergo surgical aortic valve replacement each year However transcatheter aortic valve replacement TAVR has become the gold standard for inoperable patients and has shown equivalence if not improved survival compared to surgery in intermediate and high risk patients Now TAVR is moving to the surgical patient population but its durability is far inferior estimated to be years compared to years with surgical bioprostheses The goal of this project is to develop a two component transcatheter aortic valve consisting of a base and modular valve component so that young surgical patients can have a transcatheter approach which allows these valves to be removed and replaced without surgery when these valves fail