HighLife, a company focused on development of a novel trans-septal mitral valve replacement (TSMVR) system for moderate to severe mitral regurgitation (MR), has received U.S. Food and Drug Administration (FDA) breakthrough device designation for its TMVR solution.
MR occurs when the heart’s mitral valve doesn’t close completely and blood leaks back across it, instead of continuing to supply organs with oxygenated blood. Many MR patients at high surgical risk have limited treatment options and TSMVR solutions present a less invasive alternative to open-heart surgery.
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HighLife’s TSMVR features a valve-in-ring concept, with both the ring and valve implanted percutaneously. The tech is deployed in a three-step procedure into the beating heart, reducing patient trauma. It’s currently being assessed in clinical studies across three continents, including a pivotal investigational device exemption (IDE) study that was granted in June 2024.
The FDA’s breakthrough device program provides HighLife with access to more frequent FDA interactions to facilitate a quicker path to approval and potential for earlier access to patients and providers.
“We are honored to receive the breakthrough device designation by the FDA,” said HighLife CEO Stefan Pilz. “HighLife has made significant clinical progress and is addressing a huge unmet clinical need. This designation recognizes the potential of HighLife to become the standard of care in mitral regurgitation treatment once FDA approved and deployed.“
