Medtronic said it's making a strategic investment in Pi-Cardia, a pioneer in leaflet modification technologies for structural heart disease.
Pi-Cardia's ShortCut device is the first FDA-cleared leaflet modification technology designed to enable valve-in-valve TAVR procedures in patients at risk of coronary obstruction. The device provides physicians with a safe approach to leaflet modification that can help preserve coronary access and enable future transcatheter valve procedures. In FDA-reviewed clinical studies, ShortCut demonstrated successful leaflet splitting in all pivotal trial patients and a favorable safety profile.
Under the agreement, Medtronic will make strategic investments of up to $80 million into Pi-Cardia and is expected to become the exclusive global commercial distributor of the ShortCut device in 2027.
Medtronic will use its worldwide Structural Heart organization to expand physician access across the United States, Europe, Japan and other international markets. The agreement also includes an option for Medtronic to acquire Pi-Cardia upon achievement of predefined milestones for an estimated upfront acquisition price of up to $210 million.
"Our mission has been to make leaflet modification a standard part of complex TAVR," said Pi-Cardia CEO Erez Golan in a statement. "Medtronic is the right partner to help us achieve this vision given their global reach and commitment to bringing innovative tools to physicians and patients worldwide. We are confident this collaboration will accelerate adoption of ShortCut while continuing to advance the future of leaflet modification."
The strategic investment secures an option for Medtronic to strengthen its structural heart portfolio option by adding a first-of-its-kind technology that addresses a significant challenge in valve-in-valve TAVR while complementing the company's leadership in transcatheter valve therapies.
