FDA Approves P&F USA’s TRICAV II Clinical Trial

P&F USA Inc., the U.S. subsidiary of heart valve manufacturer P&F Products and Features GmbH, has secured U.S. Food and Drug Administration (FDA) approval to begin its TRICAV II pivotal trial, which 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 received FDA 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.

“TricValve represents an important advancement,” said Samir Kapadia, M.D., chairman of Cardiovascular Medicine at Cleveland Clinic and principal study 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.”

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. Consequently, 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,” P&F Co-Founder/CEO Katharina Kiss, M.D., and President/Chief Operating Officer Siegfried Einhellig stated. “The TricValve system was developed specifically to address this underserved population with a safe, minimally invasive solution.”

TricValve is CE-marked and commercially available in approximately 70 countries, with more than 3,000 patients treated. In the United States, it is an investigational device.

Based in Vienna, Austria, P&F Products and Features GmbH is a global developer of cardiovascular solutions with more than 25 years of experience and operations.