Israel’s Pi-Cardia (see here previously) has received US-FDA approval for its ShortCut heart valve decalcification device. ShortCut is used to remove calcium from heart valves, making them more flexible, prior to heart valve replacement (e.g. TAVR or TMVR) procedures. https://www.businesswire.com/news/home/20240928442730/en/Pi-Cardia-Receives-FDA-Market-Clearance-for-ShortCut%E2%84%A2

The US FDA has just granted Breakthrough Device status to Israel’s PI-Cardia (see here previously) for its ShortCut ™ device that facilitates Transcatheter Aortic Valve Replacement (TAVR) procedures. https://www.businesswire.com/news/home/20240122184265/en/Pi-Cardia-Receives-FDA-Breakthrough-Device-Designation-for-ShortCut%E2%84%A2

The calcification of heart valves is currently resolved by transplanting a new prosthetic valve (see above). Israel’s Pi-Cardia (see here previously) has been developing the Leaflex system to treat the calcification, and is currently conducting human clinical trials across Europe. … Continue reading →

Instead of open-heart surgery, doctors at Jerusalem’s Shaare Zedek Medical Center performed the world’s first catheterizations to unblock heart valves, including of a 96-year-old woman. They used the “ShortCut” – a tiny knife inside a catheter, developed together with Israeli … Continue reading →

Israel’s Pi-Cardia has developed the Leaflex Catheter System – a novel non-implant based technology for treating patients with aortic valve stenosis, rather than replacing the heart valve. Pi-Cardia has just raised $10 million to help complete development of a second-generation … Continue reading →