May 9, 2025 — Tampa General Hospital (TGH) and USF Health have successfully completed the first TricValve® procedure in Florida, marking a significant milestone in the FDA’s Early Feasibility Study. The procedure, performed in April 2025, was conducted on a patient suffering from severe Tricuspid Regurgitation (TR), a life-threatening heart condition.
The procedure was carried out by Dr. Hiram Bezerra, director of the TGH Minimally Invasive Valve Program, director of the TGH Interventional Cardiology Center of Excellence, and a professor at the USF Health Morsani College of Medicine. Dr. Fadi Matar, Interventional Heart Failure Program director, medical director of the Cardiac Cath Lab at the TGH Heart & Vascular Institute, and professor at the USF Health Morsani College of Medicine, also participated in the procedure. This marks the first step of the TRICAV 1 clinical study, which is led by the clinical research team at the University of South Florida and aims to evaluate the TricValve® device for broader patient use.
“Cardiac disease remains the leading cause of death in the U.S., and severe tricuspid regurgitation represents a critical unmet medical need,” said Dr. Bezerra. “Tampa General is dedicated to advancing therapeutic options that offer improved benefits for our patients. As a leading academic medical center, we are excited to be the first in Florida to help move this promising technology closer to FDA approval.”
Tricuspid regurgitation, which affects over 1.6 million Americans, occurs when the tricuspid valve fails to close properly, causing blood to flow backward into the heart. This condition reduces blood flow, especially to the lungs and extremities, and can lead to heart failure if untreated. Many patients with severe TR are not candidates for traditional open-heart surgery, underscoring the need for alternative treatments.
The TricValve® System is a minimally invasive device that is implanted using a transcatheter approach. It works by placing a bicaval valve system into the inferior and superior venae cavae (the two large veins returning blood to the heart’s right atrium), which reduces the backward blood flow caused by severe tricuspid regurgitation and provides relief from symptoms. This technique avoids the risks associated with open surgery.
Dr. Matar expressed his gratitude, stating, “Tampa General’s Heart and Vascular Institute offers world-class care, from routine procedures to pioneering interventions, benefiting both the Tampa community and patients beyond. We are deeply thankful for our donors’ support, which helps make this groundbreaking work possible.”
Dr. Bezerra is also a principal investigator in the TRICAV 1 study, a multi-center clinical trial sponsored by P&F Products and Features, a global leader in cardiovascular technology. The study aims to evaluate the safety and effectiveness of the TricValve® System in patients with severe TR who are not suitable for traditional surgery due to high risk.
At the forefront of the TRICAV 1 clinical trial, the USF Department of Internal Medicine is recognized nationally for its leadership in cardiovascular research. The department conducts cutting-edge research in heart failure, electrophysiology, interventional cardiology, general cardiology, and cardiac imaging, working to address some of the most pressing challenges in medicine today.
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