Mitria’s Subvalvular Spacer for Mitral Valve Repair Implanted in First Compassionate-Use Case 

March 6, 2026—Mitria Medical announced the first implantation of its subvalvular spacer (SVS) in the United States in a compassionate-use procedure under the FDA’s Single-Patient Expanded Access Program. Mitria is structural heart company developing this next-generation transcatheter solution for mitral valve repair.

According to Mitria Medical, the investigational SVS device is a nitinol braid designed to address posterior leaflet tethering, preserve anterior leaflet motion, and provide an anatomically versatile transcatheter option for the treatment of functional mitral regurgitation (MR).The procedure was performed at the Cleveland Clinic in Cleveland, Ohio.

The press release advised that Mitria Medical was established by Cleveland Clinic Innovations in 2019 as a Cleveland Clinic portfolio company to commercialize the SVS technology.

Jose Navia, MD, and Samir Kapadia, MD, who are coinventors of SVS and have equity ownership rights in Mitra Medical, commented on the device and procedure in the company’s press release.

Dr. Navia is Vice Chief of the Heart, Vascular & Thoracic Institute at Cleveland Clinic Florida in Weston, Florida. Dr Kapadia is Chair of the Department of Cardiovascular Medicine at the Cleveland Clinic in Cleveland, Ohio.

“Although percutaneous treatment options for MR are available and well established, there are patients who are ineligible for these therapies because of their anatomy,” commented Dr. Navia. “This new device may provide an important treatment option and help overcome some of the limitations of current therapies for patients with functional MR.”

Dr. Kapadia added, “Continued innovation is essential due to the complex morphology of mitral valve disease. The device performed as intended, and we are looking forward to further clinical evaluation of this promising technology.

Mitria Medical noted that before the United States compassionate-use case, successful implantations of the SVS were performed in Tashkent, Uzbekistan and Asunción, Paraguay.