Pi-Cardia

medical devices

About

Pi-Cardia is a global medical device company based in Israel, focused on developing innovative, non-implant, catheter-based solutions for structural heart valve disease. The company specializes in next-generation valve repair technologies that offer safe and effective treatment options without the need for permanent implants. Their core products include the ShortCut™ Device, the first dedicated leaflet splitting device designed to enhance the safety of Transcatheter Aortic Valve Replacement (TAVR) procedures, and the Leaflex™ Device, which mechanically scores calcified valve leaflets to improve flexibility and valve function. Both devices are investigational in the U.S. and have received FDA market clearance and Breakthrough Device Designation. Pi-Cardia's technologies aim to address critical needs in heart valve disease treatment, particularly for patients with calcified aortic stenosis and those at risk during valve replacement procedures. The company targets cardiologists, cardiac surgeons, and healthcare providers, striving to improve patient outcomes through minimally invasive interventions.

Technologies

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Keywords

medical device aortic stenosis precautions cathetersystem cardiovascular leaflet modification leaflet splitting medical equipment manufacturing healthcare equipment & supplies tavr adjunct leaflet modification for coronary access medical devices investigational device transcatheter aortic valve intervention structural heart disease treatment cost-efficient valve therapy medical equipment and supplies manufacturing non-implant valve treatment aortic valve repair short hospital stay solution non-implant heart valve therapy heart valve calcification treatment fda de novo device cost-effective structural heart solutions fda cleared device cost-effective treatment cardiovascular devices coronary obstruction prevention healthcare technology leaflet mobility restoration medical technology

Location

5 David Fikes Street, Rehovot, Center District, Israel, 7632805

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