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 →