Medtronic has announced a strategic investment in Pi-Cardia, developer of ShortCut and other leaflet modification technologies for the treatment of heart valve disease.
With a focus on addressing the evolving needs of increasingly complex transcatheter aortic valve implantation (TAVI) patients and procedures, Medtronic secures an option for strengthening its structural heart portfolio through the investment, supporting the next generation of innovation, the company has stated in a press release.
Pi-Cardia’s ShortCut device is the first US Food and Drug Administration (FDA)-cleared leaflet modification technology designed to enable valve-in-valve TAVI procedures in patients at risk of coronary obstruction. The device provides physicians with a safe, easy-to-learn, reproducible 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 favourable safety profile.
“As structural heart care evolves, we’re investing in technologies that help physicians address today’s challenges while preparing for tomorrow’s opportunities,” said Jorie Soskin, vice president and general manager of the Structural Heart business within Medtronic’s Cardiovascular portfolio. “Our investment in Pi-Cardia reflects our commitment to building a portfolio of technologies that will shape the future of TAVI, particularly for patients with complex anatomy. We believe leaflet modification technologies like ShortCut have the potential to become an important component of structural heart care and the future of TAVI as transcatheter therapies continue to advance.”
Under the agreement, Medtronic will make strategic investments of up to US$80 million into Pi-Cardia and is expected to become the exclusive global commercial distributor of the ShortCut device in 2027. Medtronic will leverage its worldwide structural heart organisation to expand physician access across the USA, 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 US$210 million, subject to customary adjustments, plus additional potential earn-out payments post-acquisition that could meaningfully increase the total consideration. The transactions are subject to regulatory approval and customary closing conditions.
“Our mission has been to make leaflet modification a standard part of complex TAVI,” said Erez Golan, CEO of Pi-Cardia. “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.”
Pi-Cardia was founded by Golan and Eyal Kolka, and is backed by experienced medtech investors including Sofinnova Partners, Sprig Equity, and Jacques Séguin.
