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

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