OUR TECHNOLOGY
Using a combination of state-of the-art polymers and unique design optimization approach, PolyNova transcatheter heart valve technology addresses the intrinsic limitations of current tissue-based valve products
State of the art polymeric formulation
The polymer that we use for the PolyV-2 is based on the thermoplastic elastomer, which has been successfully utilized in commercial medical applications (e.g., for stent paving and for glaucoma patients). A novel cross-linked thermoset formulation of that elastomer was developed and optimized for its valve application which is capable of withstanding the high dynamic loading conditions characterizing valvular function. It retains the excellent hemocompatibility and biostability of the thermoplastic origin, yet is both flexible and far more durable.
Design optimized for extended durability
The PolyV-1 design incorporate features aimed to extend its durability and long-term performance, which are critical following the current expansion of TAVR to younger patients.
This include varying thickness of the leaflets’ profile, and fabricating the leaflets in their nominal conformation (‘zero-stress’ position) to semi-open, reducing the accumulated flexural stresses during the cardiac cycle, and extending the valve durability. Our PolyV-1 passed 1 billion cycles of accelerated wear testing (equivalent to 25 years in a patient’s body)- that is five times the ISO 5840 required by the FDA!
Superior hydrodynamic performance
The PolyV-1 has demonstrated superior hydrodynamic performance compared to reference surgical tissue valves or transcatheter tissue valves. This includes wide circular opening, large effective orifice area (EOA), and low pressure gradients. Our durability testing indicates that the EOA and the regurgitation fraction profile are fully maintained with no deterioration so far.
Minimal thrombogenicity profile
The PolyV-1 hemodynamics profile demonstrated very low thrombogenicity, significantly lower than reference tissue transcatheter valves, and at the same level as surgical tissue valves (that inherently have better thrombogenic profile than TAVR valves)
Resistance to crimping damage
Crimping is one of the major design requirements for transcatheter heart valves, and crimping damage is the Achilles’ heel of tissue-based valves – those suffer irreversible damage to the tissue leaflets even before the implantation, which limits the lifetime and long-term performance of the device. Our polymeric valve has demonstrated resistance to crimping damage, even after prolonged crimping duration of 8 days. This is a major advantage of delivering the device pre-crimped to potential customers.
Minimum susceptibility to calcific deposition
Calcification susceptibility is one of the major issues of tissue-based valves in-vivo, leading to structural calcific degeneration, and limits the valves durability. The PolyV-1 exhibited resistance to calcific deposition in an accelerated in-vitro testing, 85-times less accumulation compared to clinically used surgical tissue valve.
Production method - PolyV-2
Both the PolyV-1 and our second-generation PolyV-2 valves are produced through compression molding, utilizing micron-precision molds that enable stringent control over the optimized variable thickness of the leaflets, which is essential for valve durability. Consequently, our polymeric valve products exhibit high reproducibility and are well-suited for mass production techniques. This ensures that our polymeric valves are manufactured to the highest quality standards, with minimal human error and the need to discard most of the harvested specimens (inherent to tissue based technology)- further lowering the production costs.
PolyV-2 represents the second generation of our TAVR devices, building upon the foundation established by our first-generation valve, PolyV-1. While maintaining the same design and optimization principles as PolyV-1, PolyV-2 incorporates a modified stent design and introduces a novel feature: a suture-less device. In this design, the stent is embedded within the polymer and isolated from the blood flow, which enhances the thromboresistance of the device.
PolyNova does not currently market or sell any medical devices. The FDA has not approved any PolyNova products for use in the United States of America. PolyNova does not hold any CE Marks. This website may contain forward-looking statements and is for informational purposes only.