P&F Products Achieves Important EU MDR Certification for TricValve® System

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

On February 5, 2026, P&F Products and Features GmbH, a leading MedTech firm specialized in heart valve innovations, proudly announced it has received CE Mark certification under the European Union Medical Device Regulation (MDR) for its groundbreaking TricValve® Transcatheter Bicaval Valve System. This certification is pivotal, confirming TricValve's adherence to the stringent regulatory standards set forth by the EU for medical devices.

The TricValve system stands as a Class III active implantable medical device specifically designed for patients suffering from symptomatic severe tricuspid regurgitation (TR) and caval reflux, particularly those who are at high risk for traditional open-heart surgery. Notably, patients’ eligibility is inclusive of varying native tricuspid annulus sizes and anatomical structures, with no contraindications posed by the presence of pacemaker leads, making the device adaptable for a wide range of patients.

With MDR certification backing the TricValve system, P&F marks an important step forward after initially securing CE certification under the prior Medical Device Directive (MDD) in 2021. MDR introduces a new level of regulatory and surveillance obligations, replacing the MDD and ensuring updated standards are met. Devices previously certified under the MDD must comply with the MDR by May 2027 to remain available within the EU market.

Dr. Katharina Kiss, CEO of P&F Products, emphasized the significance of this achievement, stating, “Reaching MDR CE certification for TricValve is a major milestone for PF. This rigorous process not only highlights our strong clinical data and quality management systems but also affirms our team's unwavering commitment. This certification secures TricValve's continuous availability throughout Europe and bolsters our ongoing international expansion efforts, including initiatives aimed at entering the U.S. market.”

Severe tricuspid regurgitation is a prevalent and debilitating condition that often leads to right heart failure (RHF), diminished quality of life, and frequent hospital visits. For various reasons—including age, medical frailty, anatomical peculiarities, and comorbid conditions—many patients are unsuitable for surgical interventions, while minimally invasive treatment alternatives remain limited. It is estimated that approximately 1.6 million individuals in the United States suffer from clinically significant TR.

The TricValve system employs a minimally invasive, catheter-based approach designed to alleviate caval reflux while enhancing cardiac output through the implantation of self-expanding valves within the venae cavae. Clinical experiences with the TricValve system have documented notable reductions in RHF symptoms and substantial patient condition improvements.

Currently, TricValve is commercially accessible in around 70 countries, with more than 3,000 patients treated globally. It is important to note that in the U.S., TricValve is categorized as an investigational device, with its use limited to specific FDA IDE protocols.

P&F Products and Features GmbH, headquartered in Vienna, Austria, draws on over 25 years of expertise in developing pioneering cardiovascular solutions. With operations spanning approximately 70 countries and production facilities in Europe, Asia, and Brazil, P&F is poised for further advancements in the MedTech industry. For more information, visit productsandfeatures.com.