Artificial Polymeric Valves System and Methods of Making and Using Thereof

Background:

Heart valve related diseases remain a significant public health issue affecting an estimated 2% of the population with 4% of those over 65 having aortic stenosis (AS), a narrowing of the valve opening which can lead to heart failure. The traditional treatment for AS, surgical aortic valve replacement, is a highly invasive open-heart surgical procedure that is not suitable for all patients. Transcatheter aortic valve replacement (TAVR) has emerged as a less invasive alternative, rapidly becoming the dominant treatment for AS. However, certain clinical complications persist, including thromboembolic risk and long-term durability issues associated with the use of tissue valves. As the utilization of TAVR continues to increase in younger and lower-risk patient populations, identifying a solution that mitigates these complications is of growing clinical significance. Polymeric valve solutions aim to address the shortcomings of tissue valves by providing improved resistance to damage during crimping and deployment, and through the use of hemocompatible materials with antithrombotic properties.

Technology Overview:

Researchers at Stony Brook University, in collaboration with researchers at the University of Arizona, have developed a group of novel polymeric heart valve replacement devices to address heart valve stenosis. These valves combine sutureless casting technology and unique design optimizations to overcome the intrinsic limitations of current tissue-based TAVR products. The polymer, xSIBS, is ideal for TAVR because of its excellent biocompatibility, fatigue resistance, calcification resistance, and ease of manufacturing. The researchers have valve solutions specifically designed for TAVR, as well as devices for transcatheter tricuspid and venous applications. They have also developed valves with asymmetrical leaflets that are specifically optimized for bicuspid aortic valve anatomy, providing a targeted solution for a congenital heart defect which is currently not addressed by any commercially available valve.

Advantages:

Sutureless design - Increased durability - Decreased inflammatory response - Ease of manufacturing - Varied leaflet designs optimized for specific applications

Applications:

Transcatheter aortic valve replacement - Bicuspid aortic valve stenosis - Tricuspid valve replacement - Venous valve systems

Intellectual Property Summary:

Patent Applications Published: WO2023/168270, WO2023/168278, WO2025/054300

Licensing Status:

Available

Licensing Potential:

Development partner - Commercial partner - Licensing