SBIR Phase I: Novel Self-Closing, Transcatheter, Edge-to-Edge Repair Device to Percutaneously Treat Tricuspid Valve Regurgitation Using Jugular or Femoral Vein Access

Medfree, Inc., Newark CA

Investigators

Abstract

This Small Business Innovation Research (SBIR) Phase I project develops a novel medical device enabling minimally invasive surgical revision and repair of the tricuspid valve. More than 1.6 million patients in the U.S. suffer from moderate to severe tricuspid valve regurgitation (TR) resulting in a market-size exceeding $2.4 billion by 2028. The prevalence of this repair increases with age, with women over 4 times more likely to be affected with TR than men. There are no Food and Drug Administration (FDA)-approved percutaneous devices for TR treatment. Isolated TR surgery is rarely performed due to the inherent risks associated with major surgery with post-operative complications resulting in high morbidity and mortality rates of 36.1% among severe TR patients. Hence, only about 8,000 of all U.S. patients with moderate to severe TR currently receive surgical treatment. This Small Business Innovation Research (SBIR) Phase I project develops a novel, percutaneous, catheter-based device and procedure for surgically revising the tricuspid Valve in patients suffering from Tricuspid Regurgitation (TR). The tricuspid valve is the largest of the four heart valves presenting unique challenges due to its complex anatomy including 3 thin leaflets and location. The valve is difficult to access using traditional femoral vein access. This project aims to provide a novel, low-profile catheter and implant device via the jugular vein. The Phase I objectives include demonstrating the ability to grasp valve leaflets, validating the design using a benchtop model simulating human conditions, further designing, developing and validating an animal model, and performing a transcatheter tricuspid edge-to-edge repair (t-TEER) procedure via the jugular vein in a lab setting. The results from the technology development, bench testing. and preclinical models will further the system towards eventual human use. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.