Mitria Medical Announces First Use of Novel Mitral Valve Repair Device in U.S. Under Single Patient Expanded Access

CLEVELAND, March 5, 2026 /PRNewswire/ -- Mitria Medical, a structural heart company developing a next generation transcatheter solution for mitral valve repair, announced the first implantation of its novel Subvalvular Spacer (SVS) in the United States under the U.S. Food and Drug Administration (FDA) Single Patient Expanded Access Program. Expanded Access, often called "compassionate use", allows a patient with a serious, immediately life-threatening condition to access an investigational medical product outside of clinical trials when no satisfactory alternative options are available. The procedure was performed at Cleveland Clinic, one of the world's leading centers for cardiovascular care.

"The successful treatment of this patient with severe functional mitral regurgitation represents a significant milestone for Mitria Medical," said Rick Geoffrion, Chairman of the Board of Directors of Mitria Medical. "We are honored to have worked with the world-class clinical team at Cleveland Clinic to provide our therapy to this patient. This success reinforces our confidence in the ability of the Subvalvular Spacer to address complex mitral valve regurgitation through a minimally invasive transcatheter approach."

Mitral regurgitation is a debilitating condition where the heart's mitral valve does not close properly, allowing blood to flow backward into the heart's left atrium. If left untreated, it can lead to heart failure and death. Mitria Medical's SVS is a novel device designed to address posterior leaflet tethering, preserve anterior leaflet motion and provide an anatomically versatile transcatheter option for the treatment of functional mitral regurgitation (FMR).

"Although percutaneous treatment options for mitral regurgitation are available and well-established, there are patients who are ineligible for these therapies because of their anatomy. This new device may provide an important treatment option and help overcome some of the limitations of current therapies for patients with functional mitral regurgitation," said Jose Navia, MD, Vice Chief, Heart, Vascular & Thoracic Institute, Cleveland Clinic Florida.

"Continued innovation is essential due to the complex morphology of mitral valve disease," said Samir Kapadia, MD, Chair, Department of Cardiovascular Medicine, Cleveland Clinic. "The device performed as intended, and we are looking forward to further clinical evaluation of this promising technology."

The successful compassionate use case follows previous successful implantations of the Subvalvular Spacer in Tashkent, Uzbekistan and Asunción, Paraguay; experience with prior cases has been presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference, the American Association for Thoracic Surgery's Mitral Conclave, and Miami Valves.

In 2019, Cleveland Clinic Innovations established Mitria Medical, Inc. as a Cleveland Clinic portfolio company to commercialize the SVS technology. Dr. Kapadia and Dr. Navia have equity ownership rights as co-inventors of the Subvalvular Spacer.

About Mitria Medical
Mitria Medical is a privately held medical device company based in Cleveland, Ohio, that is developing a novel transcatheter repair solution for functional mitral regurgitation. The Subvalvular Spacer (SVS) is an investigational device designed as a nitinol braid that sits at the hinge of the posterior leaflet to provide broad support underneath the displaced leaflet to restore coaptation while preserving the valve's natural motion and orifice area.

Contact
Mitria Medical
Email: [email protected]

SOURCE Mitria Medical, Inc.