PI-CARDIA
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 designed to split the leaflets of a pre-existing valve to enable safe Transcatheter Aortic Valve Replacement (TAVR) in patients at risk for coronary obstruction or compromised coronary access.
The TAVR market, currently estimated at $5 billion, is predicted to double over the next five years, with the expansion into low-risk younger patients. However, this growth may be hindered by a fundamental challenge: During TAVR implantation, the leaflets of the pre-existing valve are pushed sideways, in a way which may compromise future coronary access in many patients. This can turn into a life-threatening complication of complete coronary obstruction in a significant number of patients who undergo a second valve implantation when their previous bio-prosthetic valve degenerates. ShortCut™ may be used in both situations to split the pre-existing valve leaflets to enable future coronary intervention and prevent coronary obstruction.
The first ShortCut™ procedures were performed in Shaare Zedek Medical Center in Jerusalem, Israel, by Dr. Danny Dvir - a leading expert in the field, who was the first to perform BASILICA procedures to prevent coronary obstruction in TAVR. “Using ShortCut™ we were able to treat two extremely complex patients with degenerated valves that needed a solution to prevent coronary obstruction after TAVR. In both patients we were able to effectively split the leaflets within minutes, allowing for a safe implantation of both self-expanding and balloon expandable TAVR valves,” said Dr. Dvir. “ShortCut™ addresses an unmet need for a simple tool to prevent coronary obstruction, which I strongly believe can easily be adopted by all TAVR centers. I can also see ShortCut™ being used to prepare bicuspid valves in selected cases, by splitting the fused leaflets or tri-cuspidizing the bicuspid valves, enabling an optimal TAVR result in this patient population.”
ShortCut™ is the latest addition to Pi-Cardia’s product offering, which includes the Leaflex™ device – a standalone, non-implant-based treatment for patients with aortic stenosis. Leaflex™ performs mechanical scoring of valve calcification, in order to restore leaflet mobility and improve hemodynamics. Clinical trials are underway in the US, Europe, and China.
“We are very excited about this key milestone of demonstrating clinical feasibility with ShortCut™, which allows us to move forward with our clinical plan in the US and Europe,” said Erez Golan, Pi-Cardia’s Chief Executive Officer. “As the number of patients with aortic stenosis continues to grow, both Shortcut™ and Leaflex™ may offer important new treatment options for both physicians and patients.”
About Pi-Cardia
Pi-Cardia is a global leader in the development of unique non-implant-based solutions for treating heart valves. Pi-Cardia's lead product, the Leaflex™ device, is easily delivered and positioned on the valve, to then mechanically score the calcification at multiple locations, restoring leaflet flexibility and improving valve hemodynamics. The Leaflex™ device is designed to be a cost-effective, durable standalone treatment for patients with calcified aortic stenosis. Pi-Cardia’s second product, the ShortCut™ device, offers a safe, simple and effective way to split the leaflets of a pre-existing valve prior to TAVR in order to maintain coronary access in patients at risk for coronary obstruction or compromised coronary access.
For more information, please visit: www.pi-cardia.net
View source version on businesswire.com: https://www.businesswire.com/news/home/20210107005066/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Nordic Firms Seek Sovereign Clouds for Compliant Modernization22.1.2026 10:00:00 CET | Press release
Enterprises reshape cloud strategies around data sovereignty, sustainability requirements and AI-native operations, ISG Provider Lens® report says The multi public cloud services market in the Nordics has entered a defining phase as enterprises shift from selective use of the cloud to comprehensive, compliance-driven and AI-native multicloud operating models, according to a new research report published today by Information Services Group (ISG) (Nasdaq: III), a global AI-centered technology research and advisory firm. The 2025 ISG Provider Lens® Multi Public Cloud Services report for the Nordics finds that cloud adoption across the region has moved beyond basic workload migration as companies embrace sovereign cloud models that guarantee jurisdictional control and encryption frameworks. This change reflects the impact of tightening EU regulatory frameworks that require data residency, transparency and responsible AI adoption in regulated industries and the public sector. As a result, e
Vonage Network APIs Pave the Way for Freenow by Lyft to Advance Urban Mobility Innovation22.1.2026 08:00:00 CET | Press release
Freenow adopts Vonage APIs to access network capabilities, strengthening fraud prevention through faster, verified connections with drivers for millions of riders Vonage, a part of Ericsson, and Freenow by Lyft, a leading taxi and multi-mobility app in Europe, have expanded their partnership with the launch of Vonage Silent Authentication API for customers based in the U.S. Vonage Network APIs enable Freenow by Lyft to tap into real-time network data and insights, helping prevent fraud through seamless user verification, ensuring reliable, efficient, and secure interactions for its customers and drivers. Network intelligence is becoming a critical layer of defense in the transportation space as fraud threats become more sophisticated and targeted. Enterprises worldwide lost 7.7% of their annual revenue on average due to fraud over the past year, representing an estimated $534 billion in losses.¹ With scam/authorization fraud, synthetic identity fraud, and account takeover as the leadin
Daiichi Sankyo Appoints New Leadership at the Daiichi Sankyo Translational Research Center Europe22.1.2026 07:30:00 CET | Press release
Daiichi Sankyo (TSE:4568) has appointed Veronika Rozehnal, Ph.D., to succeed Jürgen Müller, Ph.D., as the Head of the Translational Research Center Europe. Dr. Jürgen Müller will retire after nearly 30 years of research work at Daiichi Sankyo. Under his leadership, the Translational Research Center Europe, previously called the Tissue and Cell Research Center Munich, has grown from three to 40 researchers since it was founded in 1997 and has become an internationally recognized institution that plays a strategic role in the global innovation process of Daiichi Sankyo. Dr. Veronika Rozehnal joined Daiichi Sankyo in 2009 and has held various positions at the Translational Research Center Europe in addition to spending three years at the Daiichi Sankyo R&D Center in Tokyo. Dr. Rozehnal graduated from Ernst-Moritz-Arndt University of Greifswald, Germany with a Ph.D. degree in Clinical Pharmacology. “Jürgen Müller has made significant scientific contributions that have helped Daiichi Sankyo
Azafaros Announces Key Scientific Oral and Poster Presentations on Nizubaglustat Accepted for WORLDSymposium™ 202622.1.2026 07:00:00 CET | Press release
Five presentations will showcase nizubaglustat’s therapeutic potential in Lysosomal Storage Disorders. Nizubaglustat is currently being tested in two global Phase 3 studies for Niemann-Pick type C disease and GM1/GM2 gangliosidoses which are currently recruiting. Azafaros will host a satellite symposium on nizubaglustat on Day 2 of the symposium discussing the Phase 3 studies. WORLDSymposium™ 2026 takes place from February 2 to 6 in San Diego, California. Azafaros, a company building a portfolio to become a leader in lysosomal storage disorders with the goal of addressing neurological symptoms, today announced that its lead asset, nizubaglustat, will feature in five scientific presentations accepted at the WORLDSymposium™ 2026, the leading global conference on lysosomal diseases, taking place in San Diego, California, USA between February 2-6. The company’s conference activities include: Oral Presentations (including Poster numbers 134 and 29-C) Long-term data from a Phase II study wit
I Squared Announces Launch of Radiant Energy Solutions22.1.2026 07:00:00 CET | Press release
I Squared Capital (“I Squared”), a leading global infrastructure investment manager, announced today the launch of Radiant Energy Solutions (“Radiant”), an investment from I Squared’s Middle East infrastructure strategy, which is focused on targeting transformational, mid-market investments in the region. Reflecting I Squared’s platform-building approach of starting with a core initial investment and scaling over time to build market-leading businesses, Radiant marks the firm’s entry into the Middle East distributed renewables market, providing decarbonization solutions to commercial and industrial customers. The investment for Radiant is the acquisition of FAS Renewables and its 100% owned subsidiary Zahra Energy, a Saudi Arabia–based distributed solar company with a secured and advanced portfolio of over 100MWp of distributed solar projects with established customers and long-term contracted solar power purchase agreements. These include Cenomi Centers, an owner, operator, and develo
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom