The US Food and Drug Administration (FDA) has granted approval to P&F USA to begin the randomised, controlled TRICAV II pivotal trial of the TricValve transcatheter bicaval valve system for individuals with severe tricuspid regurgitation (TR) and right heart failure (RHF).

The study compares the system with optimal medical therapy (OMT) against only OMT.

TricValve is a minimally invasive treatment and has secured a breakthrough device designation, offering a treatment pathway for those who do not have surgical or transcatheter alternatives which are commercially available.

P&F USA is the subsidiary of Austria-based P&F Products and Features, a heart valve manufacturer.

The US regulator previously granted authorisation for the early feasibility trial, TRICAV I, assessing the system in 110 individuals at 50 sites in the US.

In December 2024, the FDA approved the TRICAV I’s system expansion from 15 to 50 patients at 50 US sites via the investigational device exemption (IDE) G240065.

The system has received CE Mark and is available in approximately 70 nations, with more than 3,000 patients receiving the treatment.

According to P&F USA, severe TR is linked with progressive RHF, diminished quality of life, and frequent hospitalisations.

Comprising two biological, self-expanding valves, the system is intended to address haemodynamically significant tricuspid insufficiency and caval reflux.

P&F USA noted that the system is a heterotopic solution in which the valves are implanted percutaneously into the right atrium and secured using long stents placed in the vena cava.

P&F co-founder and CEO Katharina Kiss, alongside COO and president Siegfried Einhellig, said: “The TRICAV II pivotal trial offers new hope for patients with severe TR who currently have no suitable surgical or transcatheter treatment options.

“The TricValve system was developed specifically to address this underserved population with a safe, minimally invasive solution.”