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
Galderma Delivers Record First Quarter Net Sales of 1.129 Billion USD, Including Strong Performance From Two Launches With Blockbuster Potential, and Confirms Full-Year Guidance24.4.2025 07:00:00 CEST | Press release
Ad hoc announcement pursuant to Art. 53 LR Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced its sales performance for the first quarter of 2025. Net sales: Achieved 1,129 million USD in net sales, up 8.3% year-on-year on a constant currency basis, primarily driven by volume, complemented by favorable mix Results ahead of expectations: Net sales benefited from focused execution, favorable phasing in Injectable Aesthetics, and stronger than expected ramp-up of Nemluvio Broad-based growth: Strong performance momentum across product categories and across geographies, with constant currency year-on-year growth of 9.9% for Injectable Aesthetics, 7.8% for Dermatological Skincare, and 4.9% for Therapeutic Dermatology, which includes net sales of 39 million USD for Nemluvio® (nemolizumab) Innovation, science and education leadership: Further advanced its category leadership in dermatology: with the launch of Nemluvio and Relfydess™ (RelabotulinumtoxinA),
Engelhart and e.optimum Strengthen Their Partnership With a Further Onshore Wind PPA, Supporting Germany’s Energy Transition24.4.2025 07:00:00 CEST | Press release
The Global Commodities and Renewable Energy Trader, Engelhart, is delighted to announce the signing of a further power purchase agreement (PPA) with e.optimum, one of Germany’s largest independent energy suppliers. Following the first PPA signed in January 2025, this new agreement secures renewable electricity from additional onshore wind turbines with a total capacity of approximately 167 MWfromJuly to December 2025. This is enough green power to supply around 31,000 households. This second PPA marks a significant expansion of the partnership between the two companies. It represents a 195% increase in contracted capacity, bringing the total from 86 MW to 253 MW of onshore wind power. Furthermore, the agreement contributes directly to Germany’s transition to a net zero-carbon economy by 2045. Matthias Seel, Senior Originator Corporate Customers Europe at Engelhart, commented: "The second PPA with e.optimum is another milestone in our joint partnership. Especially in uncertain economic
Textron Aviation Raises the Bar for Workforce Development With State-of-the-Art Career & Learning Center23.4.2025 22:00:00 CEST | Press release
Textron Aviation Inc. a Textron Inc. (NYSE: TXT) company, today announced its new Career & Learning Center is complete and fully operational serving prospective, current and future Textron Aviation employees. Strategically located on the company’s East Wichita Campus, this state-of-the-art facility expands the training footprint to more than 75,000 square feet and provides a world-class employee experience during the application, hiring, onboarding and training processes. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250423874476/en/ Textron Aviation Career and Learning Center | Textron Aviation “The Textron Aviation Career & Learning Center is an important investment in building the next generation of aviation manufacturing, support and professional talent,” said Ron Draper, president and CEO. “Recruiting, hiring and training a world-class workforce is vital to our ability to provide the best aviation experience for our cu
TSMC Unveils Next-Generation A14 Process at North America Technology Symposium23.4.2025 20:40:00 CEST | Press release
Showcasing TSMC’s latest offerings for high performance computing, smartphone, automotive, and IoT applications TSMC (TWSE: 2330, NYSE: TSM) today unveiled its next cutting-edge logic process technology, A14, at the Company’s North America Technology Symposium. Representing a significant advancement from TSMC’s industry-leading N2 process, A14 is designed to drive AI transformation forward by delivering faster computing and greater power efficiency. It is also expected to enhance smartphones by improving their on-board AI capabilities, making them even smarter. Planned to enter production in 2028, the current A14 development is progressing smoothly with yield performance ahead of schedule. Compared with the N2 process, which is about to enter volume production later this year, A14 will offer up to 15% speed improvement at the same power, or up to 30% power reduction at the same speed, along with more than 20% increase in logic density. Leveraging the Company’s experience in design-tech
Veracode Delivers End-to-End Risk Coverage with New Tools: AI-Powered Dynamic Analysis Security Testing with External Attack Surface Management23.4.2025 17:42:00 CEST | Press release
Seamless Integration and Speed: Latest Innovations Empower Faster, Smarter, and Safer Software Security Veracode, a global leader in application risk management, today announced new capabilities to help organizations address emerging threats, giving security professionals better visibility and control in one place. The launch includes new AI-powered functionality in the Dynamic Application Security Testing (DAST)product and an External Attack Surface Management (EASM) capability. Together, they enable security teams to discover their entire attack surface and prioritize the most critical risk to streamline and simplify security scanning. “Security teams need to see and secure everything; not only what is inside their perimeter,” said Derek Maki, Head of Product at Veracode. “With our latest DAST capabilities and Application Risk Management platform enhancements, we’re helping organizations shift from vulnerability scanning to holistic risk management, to better identify risk residing i
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