P&F secures FDA approval for TRICAV II pivotal clinical trial for severe tricuspid regurgitation

TRICAV II will evaluate the safety and effectiveness of the TricValve® Transcatheter Bicaval Valve System

WILMINGTON, Del., Dec. 12, 2025 /PRNewswire/ -- P&F USA, Inc., the U.S. subsidiary of heart valve manufacturer P&F Products and Features GmbH, today announced that the U.S. Food and Drug Administration (FDA) has approved initiation of the TRICAV II Pivotal Trial. The study will evaluate the TricValve® Transcatheter Bicaval Valve System, a minimally invasive therapy for patients suffering from severe tricuspid regurgitation (TR) and right heart failure (RHF). The TricValve has a Breakthrough Device designation, recognizing its potential to offer a needed treatment option for patients with no surgical or commercially available transcatheter options.

TRICAV II pivotal trial is a randomized, controlled study comparing the TricValve system with optimal medical therapy (OMT) versus OMT alone. The FDA previously authorized TRICAV I, the early feasibility study evaluating the TricValve system in 110 patients at 50 U.S. sites. TRICAV II advances its clinical development.

Severe TR affects an estimated 1.6 million people in the United States and is associated with progressive RHF, reduced quality of life, and frequent hospitalizations. Many patients are poor candidates for surgery due to frailty, comorbidities, or anatomical challenges. Others cannot be treated with currently available transcatheter therapies. As a result, a substantial patient population remains without a viable interventional option, relying solely on medical therapy with poor long-term outcomes.

"The TRICAV II pivotal trial offers new hope for patients with severe TR who currently have no suitable surgical or transcatheter treatment options," said Katharina Kiss, M.D., CEO, Co-Founder of P&F, alongside Siegfried Einhellig, President and COO. "The TricValve system was developed specifically to address this underserved population with a safe, minimally invasive solution."

"TricValve represents an important advancement," said Samir Kapadia, M.D., Chairman of Cardiovascular Medicine at Cleveland Clinic and Principal Investigator, along with Michael Reardon, M.D., of Cardiac Surgery, Cardiothoracic Surgery at Houston Methodist. "Initiating this pivotal study is a significant milestone toward expanding treatment options in TR."

About TricValve and P&F
TricValve is CE-marked and commercially available in approximately 70 countries, with more than 3,000 patients treated. In the U.S., it is an investigational device under IDE# G240065 (NCT06137807).

P&F Products and Features GmbH, headquartered in Vienna, Austria, is a global leader in cardiovascular innovation with over 25 years of experience and operations. Learn more at productsandfeatures.com.

SOURCE P+F Products and Features