Medtronic plc (NYSE: MDT) announced a strategic investment of up to $80 million in Pi-Cardia Ltd., a privately held medical device company based in Rehovot, Israel, that makes leaflet modification technologies for structural heart disease.

Under the agreement, Medtronic is expected to become the exclusive global commercial distributor of Pi-Cardia's ShortCut device in 2027, with plans to expand physician access across the United States, Europe, Japan, and other international markets.

The deal 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, subject to customary adjustments, plus potential additional earn-out payments. The transactions are subject to regulatory approval and customary closing conditions.

Pi-Cardia's ShortCut device holds FDA clearance as a leaflet modification technology designed to enable valve-in-valve transcatheter aortic valve replacement (TAVR) procedures in patients at risk of coronary obstruction. In FDA-reviewed clinical studies, the device demonstrated successful leaflet splitting in all pivotal trial patients.

"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.

Pi-Cardia Chief Executive Erez Golan said Medtronic's global reach made the company the right partner to accelerate adoption of the ShortCut device.

Pi-Cardia was founded by Erez Golan and Eyal Kolka and is backed by investors including Sofinnova Partners, Sprig Equity, and Jacques Séguin.