Edwards SAPIEN M3 Gets CE Mark as First Transfemoral TMVR System
Edwards Lifesciences Corporation (NYSE: EW) has announced that its groundbreaking SAPIEN M3 mitral valve replacement system has received CE Mark approval, making it the world’s first transfemoral transcatheter mitral valve replacement (TMVR) system approved for use. This marks a significant step forward in the treatment of patients with symptomatic moderate-to-severe or severe mitral regurgitation (MR) who are not candidates for surgery or transcatheter edge-to-edge repair (TEER) therapy.
Built on the company’s well-established SAPIEN valve platform, the SAPIEN M3 system is designed to provide a new therapeutic option for high-risk patients who have historically had limited alternatives. With this approval, Edwards continues its leadership in structural heart innovations and expands its comprehensive transcatheter treatment portfolio for mitral and tricuspid valve diseases.
A Game-Changer for Mitral Regurgitation
Mitral regurgitation, the most prevalent form of heart valve disease, occurs when the mitral valve does not close properly, causing blood to flow backward into the heart. This can lead to heart failure and other serious complications. Many patients with severe MR are deemed too high-risk for surgery and are ineligible for current TEER solutions, creating an unmet need for alternative treatments.
The SAPIEN M3 system offers a completely transcatheter solution using a transfemoral approach, allowing for a less invasive procedure compared to open-heart surgery. The system is intended for patients who have no surgical options and are not suitable for TEER, providing a much-needed therapeutic advancement.
How the SAPIEN M3 Works
The SAPIEN M3 procedure involves two main steps. First, a docking device is delivered to the mitral valve area via a steerable catheter inserted through the femoral vein. This dock wraps around the native mitral valve leaflets, drawing the tissue and associated chordae tendineae inward toward the center. This action stabilizes the structure and creates a secure landing zone for valve implantation.
Next, the SAPIEN M3 valve is deployed within the dock, completing the replacement of the diseased mitral valve. Both the dock and valve are delivered through a percutaneous 29F outer diameter guide sheath, providing a fully transseptal, transfemoral approach—minimizing the invasiveness of the procedure.
Meeting an Unmet Need
“The SAPIEN M3 system represents a breakthrough for patients who have long lacked viable treatment options,” said Dr. Michael Mullen of the Barts Heart Centre, St Bartholomew’s Hospital in London. “Mitral regurgitation is a debilitating and often life-threatening condition. The unique design and transseptal delivery of the SAPIEN M3 system offer a new pathway for care that can significantly improve patient outcomes.”
Data from early clinical use of the device have shown substantial reductions in MR severity and improvements in patients’ quality of life. These encouraging results have laid the groundwork for future studies and broader clinical use.
Looking Ahead: Trials and Real-World Evidence
Edwards plans to present results from the ongoing ENCIRCLE pivotal trial of the SAPIEN M3 system in late 2025. This study will provide key insights into the long-term safety and effectiveness of the system.
In addition, a European Post-Market Clinical Follow-up Study is planned to further evaluate real-world outcomes. Patients in this study will be monitored for up to five years, underscoring the company’s commitment to building a robust body of clinical evidence.
Expanding Edwards’ Structural Heart Portfolio
With this new CE Mark, Edwards becomes the only company to offer a complete transcatheter mitral and tricuspid treatment portfolio in Europe, including both repair and replacement solutions. The company’s other CE-marked technologies include the PASCAL Precision system for mitral and tricuspid valve repair, and the EVOQUE tricuspid valve replacement system.
“The SAPIEN M3 approval highlights Edwards’ continued leadership in structural heart therapies and our commitment to patients with limited treatment options,” said Daveen Chopra, corporate vice president of transcatheter mitral and tricuspid therapies at Edwards. “This system is the latest evolution of our proven SAPIEN platform, which has already been used in more than 8,000 mitral procedures globally.”
Availability
While the SAPIEN M3 system is now approved for clinical use in Europe, it is not yet approved in the United States. Regulatory submissions and additional clinical trials are expected to follow as part of the company’s global development strategy.
About Edwards Lifesciences
Edwards Lifesciences is a global leader in structural heart innovations, dedicated to improving patient outcomes through pioneering technologies and strong partnerships with the medical community. With a legacy spanning more than six decades, the company continues to drive progress in heart valve therapy and critical care monitoring.
