Startup behind new heart device partners with medtech incubator

Mitria Medical, a new medtech company founded at Cleveland Clinic, is partnering with Silicon Valley incubator T45 Labs to further develop a new investigational transcatheter mitral valve repair therapy for functional mitral regurgitation (FMR).

The Subvalvular Spacer (SVS) device was designed to help clinicians perform transcatheter mitral valve repair in patients who cannot be treated with mitral edge-to-edge clip repairs of the leaflets. In patients with FMR, remodeling of the heart distorts the valve and prevents proper closure due to displacement of the papillary muscles and leaflet tethering, resulting in regurgitation. The Mitria SVS provides an anatomically versatile transcatheter implant to reposition the anatomy to its correct position, improving leaflet closure.

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The device was co-invented by Samir Kapadia, MD, chair of the department of cardiovascular medicine at Cleveland Clinic, and Jose Navia, MD, vice chief of the Heart, Vascular and Thoracic Institute at Cleveland Clinic Florida. They performed the first U.S. implantation of the device at Cleveland Clinic under the FDA's Single Patient Expanded Access Program in March 2026.

"We are thrilled to have Mitria join the T45 portfolio. The differentiated mitral repair technology has demonstrated a meaningful early clinical experience to address the limitations of edge-to-edge valve repair, potentially expanding treatment options for patients with functional mitral regurgitation," Marwan Berrada-Sounni, founder and managing partner of T45 Labs, said in a statement. "The Cleveland Clinic Innovations program nurtured the promising SVS technology, and we look forward to advancing the development and clinical evaluation backed by T45 Labs' hands-on operating model, cardiovascular expertise, and company development acumen."

Berrada-Sounni was also recently named CEO of Mitria Medical to lead the next phase of the SVS clinical evaluation.

Dave Fornell is a digital editor with Cardiovascular Business and Radiology Business magazines. He has been covering healthcare for more than 16 years.

Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]

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