The Need

Heart valve (HV) therapy is the second most common cardiac intervention in the U.S. with transcatheter delivery the dominant surgical approach. Most procedures employ mechanical (MHV) or bioprosthetic (BHV) devices. However, MHVs involve a significant risk of thromboembolism and require lifelong anticoagulation therapy while BHVs, composed of porcine or bovine tissues, are susceptable to tissue degeneration and subsequect re-operation. The rapid growth rate of transcatheter procedures and the expanding indications for this therapeutic approach create a fertile ground for improvements in HV design.

The Technology

Dr. Dasi and his team at The Ohio State University have designed a suite of novel HVs for transcatheter delivery that address both the issues of thrombogenicity and tissue degeneration present with current, commercially available HVs. Their approach comprises biomolecule-enhanced polymeric leaflet materials and optimized biomechanical design. Flexible posts and unique stent clips provide improved leaflet hemodynamics comparable or superior to BHVs as well as the enhanced durability offered by MHVs. For the leaflet material, the introduction of hyaluronic acid into the synthetic polymers substantially reduces thrombogenicity and improves biocompatability.

The Dasi team have a strong interest in seeing this HV technology spun out into a start-up venture for accelerated movement along the regulatory pathway.

Commercial Applications

• Transcatheter aortic valve replacement (TAVR)

Benefits/Advantages

• Reduced thrombogenicity from use of hyaluronic acid/glycosaminoglycan/polymer composite as leaflet material (exclusively available under Inter-Institutional Agreement with Colorado State University)
• Equivalent or lower levels of turbulence and viscous shear stresses compared to Edwards Sapien 3 and Medtronic CoreValve
• Higher effective orifice; minimal reverse flow of blood upon leaflet closure
• Single-piece, low stitch-count leaflet material reduces manufacturing cost
• Frame geometry allows crimping to smaller diameter than current devices for ease of delivery