P&F Secures EU MDR CE Certification for TricValve® System

Certification strengthens European market access and supports future global growth

VIENNA, Feb. 5, 2026 /PRNewswire/ -- P&F Products and Features GmbH, a global heart valve MedTech company focused on transcatheter solutions for structural heart disease, today announced it has received CE Mark certification under the European Union Medical Device Regulation (MDR) 2017/745 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, M.D., 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 U.S. market."

Severe tricuspid regurgitation is a common, debilitating, and historically undertreated condition that leads to progressive right heart failure (RHF), reduced quality of life, and frequent hospitalizations. Many patients are not candidates for surgery due to age, frailty, anatomical complexity, or comorbidities, while minimally invasive treatment options remain limited. An estimated 1.6 million people in the United States suffer from clinically significant TR.

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 RHF symptoms and improvements in patient condition.

TricValve is commercially available in approximately 70 countries, with more than 3,000 patients treated worldwide. In the United States, TricValve is an investigational device limited to use under FDA IDE #G240065 (ClinicalTrials.gov Identifier: NCT06137807).

About P&F Products and FeaturesP&F Products and Features GmbH, headquartered in Vienna, Austria, is a global medical technology company with more than 25 years of experience developing innovative cardiovascular solutions. P&F operates in approximately 70 countries with production facilities across Europe, Asia, and Brazil. Learn more at productsandfeatures.com.

SOURCE P+F Products and Features