P&F Receives FDA Green Light for Clinical Trial Targeting Severe Tricuspid Regurgitation

P&F's TRICAV II Clinical Trial Receives FDA Approval

P&F USA, Inc., a subsidiary of European heart valve manufacturer P&F Products and Features GmbH, recently announced a significant milestone in cardiac care. The U.S. Food and Drug Administration (FDA) has approved the commencement of the TRICAV II pivotal trial. This study is designed to assess the TricValve® Transcatheter Bicaval Valve System, which offers a minimally invasive solution for patients suffering from severe tricuspid regurgitation (TR) and right heart failure (RHF).

The TricValve has earned a Breakthrough Device designation from the FDA, emphasizing its potential to serve as a pivotal treatment option for patients who currently lack effective surgical or commercial transcatheter alternatives.

Understanding Severe Tricuspid Regurgitation

Severe TR is a cardiovascular condition affecting an estimated 1.6 million individuals in the United States, leading to severe RHF, increased hospitalizations, and a significantly diminished quality of life. Many patients find themselves unsuitable for surgical intervention, either due to frailty, additional medical conditions, or anatomical challenges. Others are unable to benefit from existing transcatheter therapies. As a result, a sizable number of patients are left relying solely on medical therapies, which often yield unfavorable long-term outcomes.

The TRICAV II Pivotal Trial

The TRICAV II trial will be a randomized, controlled study that contrasts the outcomes of the TricValve system combined with optimal medical therapy (OMT) against OMT alone. This trial builds on the previous success of TRICAV I, a feasibility study that provided valuable insights while evaluating the TricValve system in a cohort of approximately 110 patients across 50 U.S. medical sites. Now, TRICAV II is set to take its development to the next level.

New Hope for Patients

Dr. Katharina Kiss, CEO and Co-Founder of P&F, expressed optimism regarding the trial, stating, "The TRICAV II pivotal trial offers new hope for patients with severe TR who currently have no suitable surgical or transcatheter treatment options." She emphasized the importance of developing solutions specifically catered to this underserved demographic.

Adding to this sentiment, Dr. Samir Kapadia, Chairman of Cardiovascular Medicine at the Cleveland Clinic and principal investigator of the trial, acknowledged the advancement represented by TricValve, saying, "Initiating this pivotal study is a significant milestone toward expanding treatment options in TR." This collaborative journey signifies a critical step for patients awaiting innovative therapies that could transform their quality of life.

About TricValve and P&F

The TricValve device is CE-marked and is already commercially available in around 70 countries, having provided treatment for over 3,000 patients globally. However, it remains an investigational device under the U.S. IDE# G240065 (NCT06137807). P&F Products and Features GmbH, headquartered in Vienna, Austria, has over 25 years of leadership in cardiovascular innovations, providing advanced solutions aimed at improving patient outcomes. For more information, explore productsandfeatures.com.

As P&F USA embarks on this transformative clinical trial, the cardiovascular community eagerly anticipates the findings that could potentially offer new avenues for patients grappling with the debilitating effects of severe tricuspid regurgitation.