Edwards Lifesciences gains CE Mark for Sapien M3 System

USA – Edwards Lifesciences has announced that its latest heart valve innovation, the Sapien M3 system, has earned CE mark approval in Europe.

This marks a major step forward in treating patients with mitral regurgitation (MR) who are not eligible for traditional surgery or TEER (transcatheter edge-to-edge repair).

The Sapien M3 is the first transcatheter mitral valve replacement system approved in Europe that uses a transfemoral approach—a less invasive method that accesses the heart through a vein in the leg.

This approval now gives hope to patients with moderate-to-severe or severe symptomatic MR who previously had limited treatment options.

How Sapien M3 works

The system works in two key stages. First, a specialized docking system is delivered to the heart.

This “dock” wraps around the damaged mitral valve leaflets and gently pulls the leaflets and supporting chordae inward.

By doing so, it brings the heart’s internal structures—specifically the papillary muscles—closer together, creating a stable base.

Then, the Sapien M3 valve is placed inside this dock, fully replacing the malfunctioning native mitral valve.

Both the dock and the valve are delivered using a minimally invasive catheter that is inserted through the femoral vein, avoiding the need for open-heart surgery.

The entire process is conducted through a 29F steerable guide sheath, making it a less risky option for patients considered too frail for surgery.

Promising outcomes and ongoing research

According to Edwards, early results show the Sapien M3 system significantly reduces mitral regurgitation and improves patients’ quality of life.

The company plans to share detailed results from its ENCIRCLE clinical trial later this year, which is designed to evaluate the safety and effectiveness of the system.

The company is also initiating long-term post-market evaluations, with patient follow-ups expected to continue for up to five years to monitor real-world performance.

Daveen Chopra, Corporate Vice President of Transcatheter Mitral and Tricuspid Therapies at Edwards, emphasized the company’s long-standing commitment to structural heart innovations:

“The Sapien M3 is built on our trusted Sapien platform, which has already been used in over 8,000 mitral procedures. We were also the first to receive CE mark approval for a transcatheter tricuspid valve system.

With this latest milestone, Edwards becomes the only company offering both replacement and repair options for both mitral and tricuspid valves in Europe.”

The Sapien M3 adds to Edwards’ growing portfolio of minimally invasive heart valve solutions, expanding care options for patients across Europe.