P&F Products Achieves EU MDR CE Certification for TricValve® System
Certification strengthens European market access and supports future global growth.
Recently, P&F Products and Features GmbH, a leader in heart valve MedTech, declared it has successfully attained CE Mark certification in accordance with the European Union Medical Device Regulation (MDR) 2017/745 for its innovative TricValve® Transcatheter Bicaval Valve System. This important certification validates that TricValve meets the EU's stringent regulatory requirements for medical devices.
This MDR CE certification specifically categorizes the TricValve system as a Class III active implantable medical device that serves patients suffering from symptomatic severe tricuspid regurgitation (TR) and caval reflux who have a high risk of undergoing open-heart surgery. Notably, patient eligibility is broad, unaffected by the native tricuspid annulus size or anatomy of the right heart, and even the presence of pacemaker leads does not pose a limitation.
The achievement of MDR certification solidifies the regulatory groundwork for TricValve, following its initial CE mark approval under the previous Medical Device Directive (MDD) in 2021. The introduction of the MDR elevates the requirements associated with regulatory compliance, clinical validation, and post-market surveillance. Devices classified as Class III that were previously approved under the MDD are required to comply with the MDR by May 2027 to maintain their commercial availability in the European market.
Katharina Kiss, M.D., the Chief Executive Officer of P&F, remarked, "Securing MDR CE certification for TricValve represents a pivotal milestone for our company. This rigorous assessment highlights the robustness of our clinical data, the quality of our systems, and the dedication of our team. Furthermore, MDR certification ensures the long-term availability of TricValve throughout Europe, bolstering our ongoing international expansion, especially as we aim for progress in the U.S. market."
Severe tricuspid regurgitation is a prevalent yet greatly underestimated condition that can lead to worsening right heart failure (RHF), decreased quality of life, and frequent hospital admissions. A significant number of patients may not qualify for surgical interventions due to factors such as age, frailty, anatomical complexity, and other health conditions. Currently, it is estimated that about 1.6 million individuals in the United States suffer from significant TR.
The TricValve system provides a minimally invasive solution through catheter-based therapy, aiming to alleviate caval reflux and enhance cardiac output by installing self-expanding valves within the venae cavae. Clinical experiences have indicated a reduction in symptoms associated with RHF and marked improvements in overall patient condition.
TricValve is presently marketed in roughly 70 countries, having treated over 3,000 patients globally. In the United States, it remains classified as an investigational device, limited to applications under FDA IDE #G240065 (ClinicalTrials.gov Identifier: NCT06137807).
About P&F Products and Features
P&F Products and Features GmbH, with its headquarters situated in Vienna, Austria, is a worldwide medical technology firm boasting over 25 years of expertise in devising cutting-edge cardiovascular solutions. Operating in approximately 70 countries, P&F has production facilities throughout Europe, Asia, and Brazil.
Frequently Asked Questions
What is the TricValve® System?
The TricValve® System is a transcatheter bicaval valve system designed for patients with severe tricuspid regurgitation.
What does CE Mark certification signify?
CE Mark certification indicates that a product meets European health, safety, and environmental protection standards.
Who is eligible to receive the TricValve® treatment?
Patients with symptomatic severe tricuspid regurgitation and caval reflux who are at high risk for open-heart surgery can be treated.
What are the advantages of the TricValve® System?
The TricValve® System offers a minimally invasive treatment option that can improve cardiac output and alleviate symptoms of RHF.
How long has P&F Products been in operation?
P&F Products has over 25 years of experience in developing innovative cardiovascular solutions.
