Piedmont Heart Institute physicians Pradeep K. Yadav, MD, Director of Structural Interventions, and Vinod H. Thourani, MD, Marcus Chairman of Cardiovascular Surgery, successfully performed a Transcatheter Mitral Valve Replacement (TMVR) using the commercial Sapien M3 valve system – a state of the art, fully-percutaneous, trans-septal valve replacement for the treatment of mitral regurgitation.

Both Dr. Yadav and Dr. Thourani were investigators and on the steering committee of the trial that studied Sapien M3 valve and co-authored results recently published in The Lancet. The U.S. Food and Drug Administration (FDA) approved the Sapien M3 valve on Dec. 22, 2025, for the treatment of severe mitral regurgitation for patients who are not good candidates for surgery or Transcatheter Edge to Edge Repair (TEER).

“This is a historic moment as it fills the huge unmet clinical need for mitral valve patients,” said Dr. Yadav. “Our experience with Sapien M3 has been exceptional with very predictable results and incredible safety, even with elderly patients with comorbidities. The procedure is very teachable as it builds on existing skills, and we look forward to disseminating to our broader physician community.”

Said Dr. Thourani: “This is a major step forward in the management for the treatment of mitral regurgitation in those patients considered high risk for traditional valve surgery.”

Sapien M3 is the first TMVR system to receive FDA approval for the treatment of mitral regurgitation – a condition that causes blood flow backward in the heart and can lead to heart failure if left untreated. Traditional solutions often required open-heart surgery or were limited to repair techniques like Transcatheter Edge to Edge Repair (TEER). The M3 system now offers:

• Expanded treatment for patients who were unsuitable for surgery or TEER.
• Valve replacement that can treat complex anatomies including calcification of the mitral valve with predictable results.
• Minimally invasive deployment through a small access in the femoral vein, allowing faster recovery.
• Demonstrated safety and effectiveness in clinical trials with significant reduction in mitral regurgitation and improved patient outcomes.