Tag: Pi-Cardia

Pi-Cardia Reports First Commercial Cases with ShortCut™

BOSTON–(BUSINESS WIRE)–Pi-Cardia Inc., a global leader in the development of leaflet modification solutions for treating heart valves, announced today the first commercial procedures with ShortCut™ – the world’s first dedicated leaflet modification device, enabling valve-in-valve (ViV) Transcatheter Aortic Valve Replacement (TAVR) procedures in patients at risk of coronary obstruction. The news […]

Pi-Cardia Receives FDA Market Clearance for ShortCut™

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 modification device, enabling valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures […]

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 dedicated leaflet modification device facilitating valve-in-valve Transcatheter Aortic Valve Replacement […]

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 split the leaflets of pre-existing valves to enable safe Transcatheter […]

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 its ShortCut™ device. ShortCut™ is the world’s first dedicated device […]

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 today a collaboration to bring Pi-Cardia’s Leaflex™ technology to China. Pi-Cardia’s […]

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 capital firm, and joined by Professor Jacques Séguin, Chairman of the […]

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 at Paris University and holds, in addition to his MD, a PhD […]

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 structures for scoring valve calcification at multiple locations, restoring leaflets […]

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 multiple locations. These scoring lines create separation between the calcium […]