Illustration of PASCAL mitral valve repair system.

Beyond the Scalpel: How a New Heart Valve Repair System Offers Hope for High-Risk Patients

Samir D’Costa in Health & Wellness December 2025 • 5 min read.

"Explore the groundbreaking PASCAL transcatheter mitral valve repair system and its potential to revolutionize treatment for severe mitral regurgitation, offering a lifeline to patients deemed too fragile for traditional surgery."

Imagine your heart working harder than it should, struggling to pump blood efficiently because of a leaky valve. This is the reality for millions living with mitral regurgitation, a condition where the mitral valve doesn't close properly, causing blood to flow backward into the heart. For many, traditional open-heart surgery has been the standard treatment, but what happens when surgery is too risky?

Mitral regurgitation affects over 10% of individuals aged 75 and older, and while surgical repair or replacement has been the conventional approach, a significant number of patients are deemed unsuitable candidates due to advanced age, weakened heart function, or other complicating health issues. This unmet need has driven the development of less invasive, transcatheter mitral valve repair (TMVr) techniques.

Now, a new innovation is offering hope: the Edwards PASCAL Transcatheter Mitral Valve Repair system. This groundbreaking technology provides a less invasive alternative for patients with severe mitral regurgitation who are considered high-risk or inoperable for traditional surgery. Let's delve into how this system works, its potential benefits, and what the future holds for this promising treatment.

The PASCAL System: A New Era in Mitral Valve Repair?

Illustration of PASCAL mitral valve repair system.

The Edwards PASCAL system represents a significant advancement in TMVr technology. Unlike earlier systems like the MitraClip, the PASCAL system is designed to address the limitations encountered in complex anatomical situations. It features a central spacer that fills the regurgitant orifice, along with wider, longer paddles that independently grasp the anterior and posterior leaflets of the mitral valve. This unique design allows for more effective reduction of mitral regurgitation, even in challenging cases.

The PASCAL system is delivered through a minimally invasive procedure. A catheter is inserted through a vein, guided to the heart, and then advanced through the septum (the wall between the heart's upper chambers) to reach the mitral valve. The PASCAL device is then deployed, with its paddles carefully positioned to grasp the valve leaflets and reduce the backflow of blood.

Here's a closer look at the key advantages of the Edwards PASCAL system:

Versatility: Effective in both functional (related to heart muscle problems) and degenerative (related to valve structure issues) mitral regurgitation.
Adaptability: Designed to address complex valve anatomies that may not be suitable for other TMVr systems.
Precision: Independent leaflet grasping allows for precise adjustments and optimal reduction of regurgitation.
Minimally Invasive: Reduces the risks and recovery time associated with open-heart surgery.

A first-in-man study, published in The Lancet, investigated the safety and efficacy of the PASCAL system in 23 high-risk patients with severe mitral regurgitation. The results were promising, with a high rate of technical success (96%) and a significant reduction in mitral regurgitation severity. At 30-day follow-up, 78% of patients experienced device success, and a majority reported improvement in their New York Heart Association (NYHA) functional class, indicating reduced heart failure symptoms.

The Future of Mitral Valve Repair: Broader Access and Improved Outcomes

The Edwards PASCAL system represents a significant step forward in the treatment of severe mitral regurgitation. Its versatility, adaptability, and minimally invasive nature offer hope for patients who were previously considered too high-risk for traditional surgery. As research continues and the technology evolves, the PASCAL system has the potential to transform the landscape of mitral valve repair, providing broader access to treatment and improved outcomes for countless individuals.

About this Article -

This article was crafted using a human-AI hybrid and collaborative approach. AI assisted our team with initial drafting, research insights, identifying key questions, and image generation. Our human editors guided topic selection, defined the angle, structured the content, ensured factual accuracy and relevance, refined the tone, and conducted thorough editing to deliver helpful, high-quality information.See our About page for more information.

This article is based on research published under:

DOI-LINK: 10.1016/s0140-6736(17)31600-8, Alternate LINK

Title: Compassionate Use Of The Pascal Transcatheter Mitral Valve Repair System For Patients With Severe Mitral Regurgitation: A Multicentre, Prospective, Observational, First-In-Man Study

Subject: General Medicine

Journal: The Lancet

Publisher: Elsevier BV

Authors: Fabien Praz, Konstantinos Spargias, Michael Chrissoheris, Lutz Büllesfeld, Georg Nickenig, Florian Deuschl, Robert Schueler, Neil P Fam, Robert Moss, Moody Makar, Robert Boone, Jeremy Edwards, Aris Moschovitis, Saibal Kar, John Webb, Ulrich Schäfer, Ted Feldman, Stephan Windecker

Published: 2017-08-01

Everything You Need To Know

What is mitral regurgitation and why is it a problem?

Mitral regurgitation is a condition where the mitral valve in the heart doesn't close properly, causing blood to flow backward. This forces the heart to work harder to pump blood effectively. If left untreated, it can lead to heart failure and other serious complications. The traditional treatment has been open-heart surgery, but this is not always an option for high-risk patients. This is where innovations like the Edwards PASCAL Transcatheter Mitral Valve Repair system come into play, offering a less invasive alternative.

How does the Edwards PASCAL system differ from earlier mitral valve repair systems like MitraClip?

The Edwards PASCAL system is designed to address limitations found in complex anatomical situations, unlike earlier systems. It features a central spacer to fill the regurgitant orifice and wider paddles that grasp the anterior and posterior leaflets of the mitral valve independently. This unique design allows for a more effective reduction of mitral regurgitation, particularly in challenging cases that other systems might not be suitable for. The MitraClip does not feature a central spacer.

Who are the ideal candidates for the Edwards PASCAL Transcatheter Mitral Valve Repair system?

The Edwards PASCAL system is designed for patients with severe mitral regurgitation who are considered high-risk or inoperable for traditional open-heart surgery. This includes individuals with advanced age, weakened heart function, or other complicating health issues that make them unsuitable candidates for surgery. The system's versatility and adaptability make it effective in both functional (related to heart muscle problems) and degenerative (related to valve structure issues) mitral regurgitation.

What are the reported benefits of using the Edwards PASCAL system based on initial studies?

A first-in-man study published in The Lancet showed promising results for the Edwards PASCAL system. The study reported a high technical success rate (96%) and a significant reduction in mitral regurgitation severity. At the 30-day follow-up, 78% of patients experienced device success, with the majority reporting improvements in their New York Heart Association (NYHA) functional class, indicating a reduction in heart failure symptoms. These results suggest that the PASCAL system can improve the quality of life for high-risk patients.

What implications does the Edwards PASCAL system have for the future treatment of mitral regurgitation?

The Edwards PASCAL system represents a significant advancement in the treatment of severe mitral regurgitation, offering hope for patients previously deemed too high-risk for traditional surgery. Its versatility, adaptability, and minimally invasive nature could transform mitral valve repair by providing broader access to treatment and improved outcomes. As research continues and the technology evolves, the PASCAL system could lead to a new standard of care, potentially reducing the need for open-heart surgery and improving the lives of countless individuals suffering from this condition.