ATLANTA, Jan. 12, 2026 /PRNewswire/ -- Piedmont Heart Institute (PHI) physicians Pradeep K. Yadav, M.D., Director of Structural Interventions, and Vinod H. Thourani, M.D., Marcus Chairman of Cardiovascular Surgery, successfully performed the first Transcatheter Mitral Valve Replacement (TMVR) on the East Coast (and second in the country) using the commercial Sapien M3 valve system – a state-of-the-art, fully-percutaneous, trans-septal valve replacement for the treatment of mitral regurgitation.

This achievement further places PHI at the forefront of advanced heart valve therapies, expanding life-changing options for patients with limited alternatives.

Dr. Yadav and Dr. Thourani were investigators and on the steering committee of the pivotal trial that studied Sapien M3 valve and co-authored results recently published in The Lancet, one of the most prestigious peer-reviewed scientific journals. 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. As one of the leaders in the country for transcatheter valve therapies, I am glad that we are able to provide this life-saving technology to our patients in the Southeastern U.S. This significantly adds to our armamentarium to treat these complex patients!"

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.

PHI, which treats patients from all 50 states, is a national destination for clinical care. PHI clinicians are leading clinical trials, publishing frequently in the world's leading medical journals and presenting at scientific sessions worldwide. Piedmont is one of the nation's top-enrolling centers in studies that include valvular heart disease, complex coronary intervention, renal denervation and beyond. For more information on the Piedmont Heart Institute Marcus Valve Center, please call 404-605-5151.

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SOURCE Piedmont Healthcare