P&F's TricValve Earns EU's Toughest MedTech Seal, Eyes Global Market

VIENNA, Austria – February 05, 2026 – P&F Products and Features GmbH announced today it has secured the highly coveted EU Medical Device Regulation (MDR) CE certification for its TricValve® Transcatheter Bicaval Valve System. This landmark approval clears the Vienna-based company to market its innovative heart valve device across the European Union under the bloc’s formidable new safety and performance standards, a milestone that solidifies its European market position and bolsters its ongoing push into the United States.

A New Era of Regulatory Scrutiny

Achieving CE certification under the EU's MDR is no small feat. Implemented in May 2021, the regulation replaced the former Medical Device Directive (MDD) with a significantly more stringent and complex framework. The MDR demands a higher level of clinical evidence, more robust technical documentation, and proactive post-market surveillance, creating a rigorous and costly pathway for all medical devices, especially high-risk Class III implants like the TricValve.

For many MedTech companies, the transition has been a resource-intensive battle. Industry reports indicate that the cost of achieving MDR certification for a single Class III device can easily surpass $100,000, with some companies spending over 5% of their annual turnover on compliance. The process requires a complete overhaul of technical files and quality management systems, and the limited capacity of accredited Notified Bodies has created significant bottlenecks, causing many to worry about device shortages.

By securing this certification well ahead of the 2027 deadline for existing devices to transition, P&F has demonstrated the strength of its clinical data and internal processes. "Achieving MDR CE certification for TricValve is a major milestone for P&F," said Katharina Kiss, M.D., Chief Executive Officer of P&F, in a statement. "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."

A New Hope for High-Risk Heart Patients

The regulatory victory has a profound human impact, offering a new option for patients battling severe tricuspid regurgitation (TR), a debilitating condition where the heart's tricuspid valve fails to close properly, causing blood to leak backward. This leads to progressive right heart failure, characterized by severe fatigue, fluid retention, and frequent hospitalizations. An estimated three million people in Europe and 1.6 million in the U.S. suffer from clinically significant TR, yet it has been historically undertreated.

A large portion of these patients are deemed too frail or high-risk for open-heart surgery, leaving them with limited therapeutic options. The TricValve system was designed specifically for this population. Delivered via a minimally invasive catheter through a vein in the leg, the system does not repair or replace the native tricuspid valve itself. Instead, it places two self-expanding biological valves in the major veins leading to the heart—the superior and inferior venae cavae. This unique "bicaval" approach reduces the backward flow of blood and alleviates the symptoms of right heart failure.

Early clinical data has been promising. Pooled results from initial studies involving 44 high-risk patients showed significant improvements in quality of life and functional status. At the one-year mark, 62% of patients saw their condition improve to a less severe functional class (NYHA Class I-II), and 95% reported an improvement in at least one quality-of-life measure. The data also indicated a low one-year mortality rate of 6.8% and a reduction in the need for diuretic medications.

The Competitive Landscape and a Unique Niche

P&F enters a dynamic and competitive market for transcatheter tricuspid valve therapies. Cardiovascular giants like Edwards Lifesciences and Abbott have already made significant inroads. Abbott's TriClip system, which repairs the native valve by clipping its leaflets together, received FDA approval in 2024 and has been used in thousands of patients globally. Similarly, Edwards Lifesciences gained FDA and CE Mark approval for its EVOQUE system, the first transcatheter replacement for the tricuspid valve.

Despite this formidable competition, TricValve's distinct mechanism of action carves out a critical niche. Its bicaval implantation is not dependent on the specific anatomy of the native tricuspid valve, making it a viable option for patients who may not be candidates for repair or direct replacement systems. Furthermore, the press release highlights that the presence of pacemaker leads—a common issue in this patient population that can complicate other interventions—is not a contraindication for TricValve. This widens its potential applicability to some of the most complex and underserved patients.

With over 3,000 patients already treated worldwide in approximately 70 countries under its previous MDD certification and other regional approvals, P&F has already established a significant global footprint. The new MDR certification now guarantees its long-term place in the burgeoning European market for tricuspid therapies.

Beyond Europe: A Global Strategy Takes Shape

The MDR certification is more than just a European victory; it serves as a powerful validation of the device's safety and performance, fueling P&F's global ambitions, particularly in the United States. The company is actively pursuing FDA approval through a structured clinical trial program under its Investigational Device Exemption (IDE).

The TricValve system was granted Breakthrough Device Designation by the FDA in 2020, a status intended to expedite the review of technologies for life-threatening conditions. The company is currently enrolling patients in its TRICAV-I early feasibility study (NCT06137807), which was recently expanded by the FDA to include 50 patients across 50 U.S. sites.

Building on this foundation, P&F announced in late 2025 that the FDA had approved the initiation of its TRICAV II Pivotal Trial. This randomized, controlled study will compare the TricValve system against optimal medical therapy alone, providing the high-level evidence required for a potential market approval application. While the path to full FDA approval is still a multi-year journey, the company's systematic approach and recent regulatory successes in Europe signal a determined push to bring this novel therapy to American patients. The successful completion of these trials would position P&F to address a significant unmet need in the world's largest medical device market.