REHOVOT, Israel–(BUSINESS WIRE)–Pi-Cardia Ltd., a global leader in the development of leaflet modification solutions for treating heart valves, announced today that the United States Food and Drug Administration (FDA) provided market clearance for ShortCut™ – the world’s first dedicated leaflet […]
Tag: Pi-Cardia
Pi-Cardia Receives FDA Breakthrough Device Designation for ShortCut™
REHOVOT, Israel–(BUSINESS WIRE)–Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today it received Breakthrough Device Designation from the US Food and Drug Administration for ShortCut™ – the world’s first […]
Pi-Cardia Successfully Completes Enrollment in Pivotal Study for ShortCut™
REHOVOT, Israel–(BUSINESS WIRE)–Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today the successful completion of its ShortCut™ Pivotal Study enrollment. ShortCut™ is the world’s first dedicated device designed to […]
Pi-Cardia Successfully Treats First Patients with ShortCut™ Device
First Dedicated Device to Enable Coronary Access and Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement REHOVOT, Israel–(BUSINESS WIRE)–Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based solutions for treating heart valves, announced today successful first-in-human procedures with […]
Venus Medtech to Partner with Pi-Cardia to Bring its Leaflex(TM) Aortic Valve Technology to China
HANGZHOU, China and REHOVOT, Israel, July 14, 2020 /PRNewswire/ — Venus Medtech (Hangzhou) Inc. (stock code: 2500.HK), the leading transcatheter heart valve medical device player in China, and Pi-Cardia Ltd., a global leader in the development of non-implant catheter-based solutions for treating heart valve calcification, announced […]
Pi-Cardia Closes a $27 Million Financing led by Sofinnova Partners to Continue Clinical Trials With Its Leaflex™ Aortic Valve Technology
REHOVOT, Israel, April 20, 2020 /PRNewswire/ — Pi-Cardia Ltd., a global leader in the development of non-implant catheter-based solutions for treating heart valve calcification, announced today it has closed a $27 million round of financing, led by Sofinnova Partners, a leading European life sciences venture […]
Pi-Cardia Appoints Prof. Jacques Séguin As Chairman
REHOVOT, Israel, Oct. 14, 2019 /PRNewswire/ — Pi-Cardia Ltd. (www.pi-cardia.net), announced today the appointment of Prof. Jacques Séguin, former CoreValve Founder and CEO and serial medical device entrepreneur, as Chairman of its Board of Directors. Jacques Séguin is a professor of Cardiac Surgery […]
Pi-Cardia First-in-Human Study Shows Significant Improvement in Aortic Valve Function Following Treatment With its Novel Non-Implant Based Leaflex™ Catheter
PARIS, May 22, 2019 /PRNewswire/ — Pi-Cardia Ltd. announced today that it successfully completed its First-in-Human study demonstrating substantial improvement in valve function following treatment with its Leaflex™ Performer catheter. The Leaflex™ Performer is a transfemoral catheter that uses two unique mechanical […]
Pi-Cardia Successfully Completes First-in-Human Studies with Novel Non-implant Based Treatment of Aortic Stenosis
REHOVOT, Israel, May 7, 2019 /PRNewswire/ — Pi-Cardia Ltd. (www.pi-cardia.net), announced today that it successfully completed the First-in-Human (FIH) studies with its Leaflex™ Performer catheter. The Leaflex™ Performer is a trans-femoral catheter that uses two unique mechanical structures for scoring valve calcification at […]
Pi-Cardia Initiates First-in-Human Study With Novel Non-Implant Based Treatment of Aortic Stenosis
REHOVOT, Israel, May 16, 2018 /PRNewswire/ –Pi-Cardia Ltd., announced today that it recently started its First-in-Human study with its Leaflex(TM) Performer catheter system. The Leaflex(TM) Performer is a trans-femoral catheter that uses two unique mechanical structures for scoring valve calcification […]