Pi-Cardia

Pi‑Cardia has developed two main non‑implant, catheter-based devices—ShortCut™ and Leaflex™—for modifying heart valve leaflets. The ShortCut™ device enables safe splitting of bioprosthetic aortic or mitral valve leaflets prior to transcatheter replacement procedures, reducing risk of coronary or LVOT obstruction. It has received FDA clearance and Breakthrough Device Designation following positive pivotal trial results. The Leaflex™ Performer mechanically scores calcification on native aortic valves to restore flexibility and improve hemodynamics as an alternative to full replacement. Both address significant unmet needs in structural heart disease management with promising safety/efficacy data from clinical studies.