Tampa General Hospital and USF Health Complete First TricValve® Procedure in Florida in FDA Early Feasibility Study

The novel treatment is in development to address critical cardiac patients with a life-threatening condition and represents a significant milestone for the academic medical system's minimally invasive valve program.

, /PRNewswire/ -- Interventional structural cardiologists at Tampa General Hospital (TGH) and USF Health have completed the first procedure in Florida under the FDA Early Feasibility Study pathway for the TricValve® System. The procedure took place in April 2025 on a patient with severe Tricuspid Regurgitation (TR), a life-threatening cardiac condition.

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, and Dr. Fadi Matar, Interventional Heart Failure program director, Cardiac Cath Lab medical director at the TGH Heart & Vascular Institute and professor and chief of cardiology at the USF Health Morsani College of Medicine, conducted the procedure. This is part of the TRICAV 1 clinical study led by the Internal Medicine clinical research team at the University of South Florida to evaluate the use of the medical device for potential broader use on patients.

"Cardiac disease remains the leading cause of death in America, with severe tricuspid regurgitation representing a significant, unmet medical need," Dr. Bezerra explained. "Tampa General is committed to constant innovation and assessment of therapeutic options that may provide a benefit over current standard of care treatments for our patients.

"Our role as a leading cardiac institute and academic medical center positions us at the forefront of research for groundbreaking interventions, and we are excited to be the first in Florida to help advance this technology towards FDA review and, if approved, broader patient use."

More than 1.6 million people in the U.S. are affected by tricuspid regurgitation, a form of heart valve disease in which blood leaks backward through the tricuspid valve, preventing it from fully closing. This failure results in reduced blood flow, particularly to the lungs and the body's extremities and causes enlargement of the lower right heart chamber. Untreated, the weakened heart muscles can lead to heart failure. People with severe tricuspid regurgitation face a low survival rate, regardless of their general health or other interventions such as medications. Many patients in advanced stages of this condition are not eligible for open heart surgery, creating a significant gap in the treatment landscape.

Interventional structural cardiologists perform the procedure with a minimally invasive transcatheter, implanting the TricValve System®, a novel bicaval valve system into the inferior and superior venae cavae (IVC, SVC), the two large veins by which blood returns to the heart's right atrium. The technique avoids the medical risks of open surgery and reduces the backward blood flow inherent in severe tricuspid regurgitation, resulting in significant relief of symptoms.

"Tampa General's Heart and Vascular Institute provides world class cardiac care, from simple procedures to groundbreaking interventions, to the Tampa community and beyond," noted Dr. Matar. "We are grateful for the support of donors who allow us to pursue this work, and proud of our talented team members and world class facilities, who work to bring these concepts from the lab to the operating room."

Dr. Bezerra is a principal investigator in the TRICAV 1 study, which is a multicenter clinical trial sponsored by P&F Products and Features, a global leader in cardiovascular medical technology. TRICAV 1 is designed to evaluate the safety and effectiveness of the TricValve System* to improve clinical outcomes and symptoms in patients with severe tricuspid regurgitation who are deemed to be at too high risk or otherwise unsuitable for surgery.

Leading the TRICAV 1 clinical trial at USF Health, the USF Department of Internal Medicine is at the forefront of innovative, interdisciplinary research that advances clinical care and medical knowledge. With a robust research infrastructure that includes dedicated faculty investigators, experienced research coordinators and strong institutional support, the department sustains a diverse and growing portfolio of high-impact studies addressing today's most pressing challenges in medicine. The department is recognized nationally for leadership in cardiovascular sciences, with active research that spans heart failure, electrophysiology, interventional cardiology, general cardiology and cardiac imaging.

A generous donation from the McKibbon Family in support of the Interventional Cardiology Center of Excellence's Minimally Invasive Valve Program helped establish Tampa General's leadership in tricuspid regurgitation. Prior to this first TRICAV 1 case, Tampa General has performed seven TricValve procedures since 2022, the highest number for any medical system in the U.S., under the compassionate use pathway that provides extremely limited access for an investigational medical product outside of clinical trials. Patient access to this therapy has been facilitated through a TGH Foundation grant from the McKibbons. The overall goal of Tampa General's minimally invasive valve program is to provide greater access to groundbreaking, lifesaving interventional procedures to more patients in the Tampa Bay area and beyond.

*CAUTION— Investigational use only. Limited by Federal or US law to investigational use only.

ABOUT TAMPA GENERAL HOSPITAL
Tampa General Hospital, a 981-bed, not-for-profit, academic health system, is one of the largest hospitals in America and delivers world-class care as the region's only center for Level l trauma and comprehensive burn care. Tampa General Hospital is the highest-ranked hospital in the market in U.S. News & World Report's 2024-2025 Best Hospitals, with two medical specialties ranking among the top 20 in the nation and eight medical specialties ranking among the top 50 best hospital programs in the United States. Tampa General Hospital has been designated as a model of excellence by the 2022 Fortune/Merative 100 Top Hospitals list. The academic health system's commitment to growing and developing its team members is recognized by three prestigious Forbes magazine rankings – in the top 100 nationally in the 2024 America's Best Large Employers, the top 50 in Florida in the 2024 America's Best Employers by State and the 2023 America's Best Employers for Women. Tampa General is the safety net hospital for the region, caring for everyone regardless of their ability to pay, and in fiscal year 2023, provided a net community benefit of approximately $301.8 million in the form of health care for underinsured patients, community education, and financial support to community health organizations in Tampa Bay. It was the nation's busiest adult solid organ transplant center in 2024 and is the primary teaching hospital for the USF Health Morsani College of Medicine. With five medical helicopters, Tampa General Hospital transports critically injured or ill patients from 23 surrounding counties to receive the advanced care they need. Tampa General houses a nationally accredited comprehensive stroke center, and its 32-bed Neuroscience, Intensive Care Unit is the largest on the West Coast of Florida. It also is home to the Muma Children's Hospital at TGH, the Jennifer Leigh Muma 82-bed neonatal intensive care unit, and a nationally accredited rehabilitation center. Tampa General Hospital's footprint includes TGH North, which is comprised of three hospitals and several outpatient locations in Citrus and Hernando counties, 17 Tampa General Medical Group Primary Care offices, TGH Family Care Center Kennedy, two TGH Outpatient Centers, TGH Virtual Health, and 19 TGH Imaging outpatient radiology centers throughout Hillsborough, Pasco, Pinellas and Palm Beach counties. Tampa Bay area residents also receive world-class care from the TGH Urgent Care powered by the Fast Track network of clinics. To see a medical care professional live anytime, anywhere on a smartphone, tablet or computer, visit Virtual Health | Tampa General Hospital (tgh.org). As one of the largest hospitals in the country, Tampa General Hospital is the first in Florida to open a clinical command center that provides real-time situational awareness to improve and better coordinate patient care at a lower cost. For more information, go to www.tgh.org.

ABOUT USF HEALTH
USF Health's mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the Taneja College of Pharmacy, the School of Physical Therapy and Rehabilitation Sciences, the Biomedical Sciences Graduate and Postdoctoral Programs, and USF Health's multispecialty physicians' group. The University of South Florida, a high-impact research university dedicated to student success and committed to community engagement, generates an annual economic impact of more than $6 billion. Through hundreds of millions of dollars in research activity each year, USF is a leader in solving global problems and improving lives. For more information, visit health.usf.edu.

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SOURCE Tampa General Hospital