P&F Products and Features has received CE mark certification under the EU Medical Device Regulation (MDR) for its TricValve transcatheter bicaval valve system. The certification confirms TricValve’s compliance with the EU’s most stringent medical device regulatory requirements.
The MDR CE certification applies to the TricValve system as a class III active implantable medical device for patients with symptomatic severe tricuspid regurgitation (TR) and caval reflux who are at high risk for open-heart surgery. Patient eligibility is not limited by native tricuspid annulus size or right heart anatomy, and the presence of pacemaker leads is not a contraindication.
MDR certification reinforces TricValve’s regulatory foundation following its original CE mark under the former Medical Device Directive (MDD) in 2021. The MDR replaces the MDD and significantly raises regulatory, clinical, and post-market surveillance requirements. Class III devices previously certified under the MDD must achieve MDR compliance by May 2027 to remain commercially available in the European Union.
“Achieving MDR CE certification for TricValve is a major milestone for P&F,” said Katharina Kiss, chief executive officer of P&F. “This demanding process reflects the strength of our clinical data, quality systems, and team commitment. MDR certification secures TricValve’s long-term availability across Europe and supports our continued international expansion, including progress toward the US market.”
The TricValve system is a minimally invasive, catheter-based therapy designed to reduce caval reflux and improve cardiac output by implanting self-expanding valves in the venae cavae. Clinical experience has demonstrated reductions in right heart failure (RHF) symptoms and improvements in patient condition.
TricValve is commercially available in 70 countries, and has been used in the treatment of more than 3,000 patients. In the USA, TricValve is an investigational device limited to use under US Food and Drug Administration (FDA) investigational device exemption (IDE).
In December 2025, FDA authorised the start of the TRICAV II pivotal trial, a randomised, controlled study comparing the TricValve system with optimal medical therapy (OMT) versus OMT alone for patients suffering from severe TR and RHF.
