Groundbreaking procedure expands treatment options for patients with severe mitral valve disease who are not candidates for traditional surgery
Naples, Fla. – June 9, 2026 – The NCH Rooney Heart Institute has successfully performed Florida’s first SAPIEN M3 Transcatheter Mitral Valve Replacement (TMVR), marking a significant advancement in structural heart care and expanding access to a newly FDA-approved treatment option for patients with severe mitral valve disease.
The procedure was performed by the NCH structural heart team led by Robert J. Cubeddu, MD, President and Brynne and Bob Colletti Endowed Chair of the NCH Rooney Heart Institute, Dee Dee Wang, MD, Section Head of Cardiac Imaging, Robert Pascotto, MD, Cardiothoracic Surgeon, and a multidisciplinary team of interventional cardiologists, cardiac imaging specialists, anesthesiologists, surgeons, nurses and cardiovascular professionals working collaboratively to deliver highly specialized structural heart care.
The SAPIEN M3 system provides a minimally invasive alternative for patients with symptomatic severe mitral regurgitation who are not candidates for surgery or other transcatheter repair options. The technology represents the first fully percutaneous transseptal transcatheter mitral valve replacement therapy approved by the U.S. Food and Drug Administration.
Unlike traditional open-heart surgery, the procedure is performed through a catheter inserted through a vein in the leg, allowing physicians to replace the diseased mitral valve without opening the chest. The innovative docking system creates a stable landing zone for the replacement valve and offers a new treatment pathway for patients who previously had few or no viable options.
“This achievement reflects the continued commitment of the NCH Rooney Heart Institute to bring the most advanced cardiovascular therapies to Southwest Florida,” said Robert J. Cubeddu, MD, President and Brynne and Bob Colletti Endowed Chair of the NCH Rooney Heart Institute. “Being first in Florida to offer this groundbreaking technology underscores our mission to ensure patients have access to innovative treatments that can improve both quality of life and long-term outcomes. For many patients with severe mitral valve disease who are not candidates for surgery, the SAPIEN M3 system represents a transformative new option.”
Mitral regurgitation occurs when the heart’s mitral valve does not close properly, allowing blood to flow backward into the heart. Left untreated, the condition can lead to heart failure, shortness of breath, fatigue and other serious complications.
“Procedures like this are only possible when every member of the care team works together seamlessly,” said Dee Dee Wang, MD, Section Head of Cardiac Imaging at the NCH Rooney Heart Institute. “At NCH, patients benefit from a true multidisciplinary approach that brings together expertise in advanced imaging, structural heart intervention, cardiac surgery and perioperative care. When patients come to NCH, they are not seeing just one physician – they are cared for by an entire team dedicated to achieving the best possible outcome.”
The milestone further strengthens the NCH Rooney Heart Institute’s reputation as one of the nation’s leading cardiovascular programs. The Institute is home to one of the nation’s most experienced valve programs, bringing together experts in structural heart intervention, advanced cardiac imaging and minimally invasive cardiac surgery led by renowned cardiothoracic surgeon Joseph Lamelas, MD, to provide comprehensive care for patients with complex valvular heart disease.
“This procedure is a powerful example of the innovation that defines NCH,” said Paul Hiltz, President and CEO of NCH. “By combining pioneering technology with the expertise of our physicians and clinical teams, we are ensuring patients in Southwest Florida have access to some of the most advanced treatments available anywhere in the country.”
The NCH Rooney Heart Institute offers a comprehensive range of cardiovascular services, including advanced imaging, structural heart interventions, electrophysiology, heart failure management, cardiothoracic surgery, vascular care, and a forthcoming transplant program. The program continues to build on its national reputation for clinical excellence, research and innovation.
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