PI-CARDIA
7.1.2021 17:02:26 CET | Business Wire | Press release
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
KiddeFenwal Launches New Website and Information Hub8.7.2026 18:00:00 CEST | Press release
Enhanced digital platform reflects KiddeFenwal’s legacy, stature and growth trajectory in the fire suppression and safety controls industry KiddeFenwal, the global leader in the fire suppression and safety controls industry, today unveiled a revitalized website, designed to serve as a comprehensive information hub for fire industry practitioners and customers alike. The modernized platform includes features created specifically with the company’s global partners, OEMs and distributors in mind, including: Accelerated asset navigation, pointing users to critical safety documentation, design parameters and product specifications; Seamless solution mapping, helping users quickly locate fire suppression configurations by industry, from data centers to BESS applications to commercial kitchens; and Enhanced resource access, including streamlined pathways to connect with the company’s elite distributor network across 120 countries. It also provides information about the company’s three brands,
Dryad Networks Reaches XPRIZE Wildfire Finals Milestone, Demonstrating Autonomous Detection and Suppression of Wildfires in Alaska8.7.2026 17:00:00 CEST | Press release
Dryad Networks, the leader in ultra-early wildfire detection technology, today announced a major achievement in the finals of the Autonomous Wildfire Response track of XPRIZE Wildfire, a four-year, $11 million global competition accelerating new solutions to end destructive wildfires. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707802818/en/ The Silvaguard Suppression Drone can deliver a 100 liter liquid suppressant to autonomously suppress small wildfires detected by Silvanet Competing against just two other finalists selected from an original field of nearly 300 teams worldwide, Dryad successfully demonstrated the integrated capabilities of its Silvanet wildfire detection network and Silvaguard autonomous firefighting drone system during final testing in remote Alaska. The XPRIZE Wildfire finals challenged teams to autonomously detect and suppress a wildfire without any human intervention across a vast 1,000 square k
Rigaku Opens "Rigaku Solutions Center Osaka" to Strengthen Global Semiconductor Metrology Service Capabilities8.7.2026 17:00:00 CEST | Press release
- Centralizing and Expanding Practical Training to Strengthen Global Service Capabilities - Rigaku Corporation, a global solution partner in X-ray analytical systems and a group company of Rigaku Holdings Corporation (headquarters: Akishima, Tokyo; CEO: Jun Kawakami; “Rigaku”), has opened the Rigaku Solutions Center Osaka (RSC-Osaka) at its Osaka Plant. The new facility centralizes and expands practical training for field service engineers supporting semiconductor metrology systems, strengthening Rigaku's global service capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708402770/en/ Photo: Hands-on training using the TXRF-V310 at RSC-Osaka As semiconductor manufacturing processes continue to advance toward finer geometries, higher layer counts, and more complex three-dimensional structures, semiconductor metrology systems require ever greater precision and operational stability. X-ray analytical technologies pl
Cardiac Dimensions® Announces Three Major Publications Demonstrating Long-Term Durability, Real-World Performance, and Broad Patient Benefit of the Carillon Mitral Contour System®8.7.2026 16:05:00 CEST | Press release
New data highlight multi-center 5-year durability, 10-year survival, and the largest single-center experience across both HFrEF and HFpEF patients with functional mitral regurgitation Cardiac Dimensions, a leader in transcatheter therapies for heart failure, today announced the publication of three major manuscripts that together form the most comprehensive evidence base ever assembled for transcatheter indirect mitral annuloplasty. These publications span a five-year multi-center commercial registry, the largest single-center experience across both preserved and reduced ejection fraction, and long-term survival results through ten years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707656796/en/ Carillon Mitral Contour System® The Carillon Mitral Contour System is the only commercially available indirect mitral annuloplasty device, designed to treat a broad and expanding population of patients living with functional mi
First Randomized Controlled Trial Shows Promise of a Ketogenic Diet in Psychotic Disorders8.7.2026 15:00:00 CEST | Press release
Trial reports correlations between ketone levels and cognitive and psychiatric symptoms in individuals with schizophrenia-spectrum and bipolar-1 disorders Published today in Schizophrenia Bulletin, a first-of-its-kind randomized controlled trial (RCT) from researchers at the University of California, San Francisco (UCSF), and funded in part by the National Institute of Mental Health (NIMH), adds to growing literature on the potential benefit of a ketogenic diet for treating psychotic disorders. The study, which enrolled participants with schizophrenia-spectrum or bipolar-1 disorders, demonstrated rapid metabolic improvements with a ketogenic diet compared to diet-as-usual during an initial one-month RCT open-label phase. Furthermore, those who continued with the optional four-month single-arm ketogenic diet extension saw meaningful gains across metabolic, psychiatric, and cognitive measures. This press release features multimedia. View the full release here: https://www.businesswire.co
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