P&F secures CE Mark Certification under the EU Medical Device Regulation (MDR) 2017/745 regulations for TricValve® Bicaval Valve System, A Breakthrough Minimally Invasive Therapy for Severe Tricuspid Regurgitation
Vienna, Austria, Feb. 5, 2026 — P&F Products and Features GmbH, a global heart valve MedTech company focused on transcatheter solutions for structural heart disease, today announced that it has obtained CE marking under Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation – MDR), which replaces the former Medical Device Directive (MDD 93/42/EEC). This new certification is intended for patients with symptomatic severe tricuspid regurgitation (hemodynamically relevant) and caval reflux, and for patients at high risk for open surgical therapy. It applies to the TricValve system as a Class III active implantable medical device. TricValve patients’ eligibility is not limited by the native tricuspid annulus size, morphology, or right atrium/right ventricle size and morphology. The presence of pacemaker leads is not a contraindication for the treatment with the TricValve system.
MDR CE marking certifies TricValve system’s compliance with the most stringent European regulatory requirements
In May 2021, the TricValve system had obtained CE marking, under the Medical Device Directive (MDD), which was in force at the time. Since then, the MDD has been replaced by the Medical Device Regulation (MDR), which significantly strengthens the requirements. Class III medical devices such as TricValve, which were CE marked under the MDD before May 2021, have until May 2027 to obtain MDR CE marking. Failing to do so would mean the device could no longer be marketed in the European Union after this date. The MDR certification confirms and reinforces TricValve’s recognition by health authorities.
A strengthened regulatory foundation to support European and international growth and future extension of TricValve’s indications
Katharina Kiss, Chief Executive Officer of P&F, concludes: “I would like to congratulate our teams on obtaining MDR CE marking for the TricValve system, following an extremely demanding process that mobilized many of our employees for months. MDR certification is a further independent recognition of TricValve’s quality and performance by health authorities. From a regulatory perspective, we have secured the right to continue marketing TricVavle across Europe beyond 2027 for patients suffering from severe tricuspid regurgitation. Finally, I would like to add that the ‘MDR’ CE marking is also extremely important in view of getting access to the U.S. market, given the FDA approval for the investigational, randomized TRICAV II pivotal clinical trial.”
A Major Unmet Need in Tricuspid Regurgitation
The tricuspid valve separates the right atrium from the right ventricle. When the native valve fails to close properly, severe tricuspid regurgitation causes blood to leak backward, leading to progressive right heart failure (RHF). This condition is common, debilitating, and historically undertreated. Many patients are not candidates for surgery due to advanced age, frailty, anatomical complexity, or comorbidities. Minimally invasive options remain limited, and outcomes for severe TR remain poor without intervention. More than 1.6 million people in the U.S. are estimated to suffer from clinically significant TR.
About the TricValve® Transcatheter Bicaval Valve System
The TricValve procedure is a non-surgical option that improves blood flow for patients with severe TR and significant RHF symptoms, using its unique bicaval valves. During this procedure, a cardiologist uses a minimally invasive catheter delivery system to position self-expanding valves just inside the right atrium. This effectively reduces caval reflux and has been shown to increase cardiac output in previous trials. The valves function by reducing backward (or regurgitant) blood flow in patients with severe TR. As a result, patients experience less blood pooling in their extremities, reduced RHF symptoms, and improved overall condition.
The TricValve system is commercially available in approximately 70 countries, with more than 3,000 patients treated worldwide.
The TricValve system is an investigational device in the United States. Use is limited by Federal law to investigational use under FDA IDE #G240065. Clinicaltrials.gov Identifier: NCT06137807
About P&F Products and Features
P&F Products and Features GmbH, headquartered in Vienna, Austria, is a global medical technology leader with more than 25 years of experience in the development, manufacturing, and commercialization of innovative cardiovascular solutions. P&F is operational in ~70 countries with production facilities across Europe, Asia, and Brazil, and is led by Dr. Katharina Kiss, CEO, and Dr. Siegfried Einhellig, President and COO.