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
INNIO Group Announces Filing of Registration Statement for Proposed Initial Public Offering11.5.2026 21:49:00 CEST | Press release
INNIO Group ("INNIO"), a leading global distributed energy solutions provider, today announces that it has publicly filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission ("SEC") relating to a proposed initial public offering of its common shares. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511389675/en/ INNIO Group Announces Filing of Registration Statement for Proposed Initial Public Offering The timing of the offering, number of shares to be offered and the price range for the proposed offering have not yet been determined. INNIO has applied to list its common shares on the Nasdaq Global Select Market under the ticker symbol "INIO." Goldman Sachs & Co. LLC, J.P. Morgan and Morgan Stanley are acting as joint lead book-running managers for the proposed offering. BofA Securities, Barclays and Citigroup are acting as book-running managers for the proposed offering. Baird, BNP Paribas
Only 7% of Companies Achieve Full Compliance as Global Expansion Increases Legal Complexity11.5.2026 15:00:00 CEST | Press release
47% of general counsels say beneficial ownership rules pose the biggest risks to legal operations44% lack confidence in meeting cross-border data security requirements As businesses accelerate their global expansion in 2026, compliance fails to keep pace. In fact, only 7% of organizations report full compliance across their global entities, according to a new study by CSC, the leading provider of global business administration and compliance solutions. CSC surveyed 350 general counsel (GCs) and senior legal professionals across Europe, North America, and Asia Pacific to examine how their teams navigate international expansion, regulatory pressure, and the increasing adoption of artificial intelligence (AI).¹ The findings appear in CSC’s latest report, General Counsel Barometer 2026: From Complexity to Control. Most organizations report partial compliance, with over half (53%) estimating they are 50–75% compliant, and a further 35% placing themselves between 76%–99%. This leaves just 7%
IFF Opens Vanilla Innovation Center in Madagascar11.5.2026 14:15:00 CEST | Press release
Advancing science‑led flavor innovation where vanilla is grown IFF (NYSE: IFF)—a global leader in flavors, fragrances, food ingredients, health & bioscience—today announced the opening of its Vanilla Innovation Center in Madagascar, reinforcing vanilla as a strategic and priority tonality for IFF and strengthening its ability to innovate at origin. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260508110162/en/ IFF's Vanilla Innovation Center in Madagascar “The opening of the center marks an important step in how we approach vanilla innovation,” said Adam Jańczuk, Ph.D., senior vice president, research, creation and design, Taste, IFF. “By strengthening our presence at origin, we connect science, creativity and sustainability more closely, responding to climate changes, safeguarding quality and creating value across the supply chain.” Located in Toamasina, Madagascar’s principal seaport, near vanilla growing areas and post‑h
ARIS Recognised as a Leader in Gartner® Magic Quadrant™ for Process Intelligence Platforms, Believes This Reinforces Its Role in Enabling Enterprise AI at Scale11.5.2026 14:00:00 CEST | Press release
ARIS, the process context foundation platform for enterprise AI deployment, today announced its recognition as a Leader in the Gartner® Magic Quadrant™ for Process Intelligence Platforms. This is the fourth consecutive year that ARIS has been recognized as a Leader in the report and the company believes it underscores a continued commitment to innovation and growth as enterprises focus on turning AI ambition into measurable business outcomes. While technology has advanced rapidly, companies are struggling to operationalise AI across complex operating models. ARIS sees this recognition by Gartner as a reflection of its strength in delivering a single unified platform for process intelligence, providing the context layer on which G2000 organisations can successfully deploy and scale agentic AI. “AI is moving from experimentation to execution – but many enterprises are finding it difficult to scale,” said Guillaume Bacuvier, CEO of ARIS. “The reason is simple: AI lacks the context it need
HistoSonics Moves to Advance Additional Histotripsy Applications Announcing FDA Submission for Kidney Tumors11.5.2026 14:00:00 CEST | Press release
HistoSonics, the developer of the Edison® Histotripsy System and novel histotripsy therapy platform, today announced it has submitted a De Novo request to the U.S. Food and Drug Administration seeking authorization to expand the use of its Edison® Histotripsy System to include the destruction of kidney (renal) tumors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511268688/en/ HistoSonics Edison® Histotripsy System This milestone marks a significant step forward in the company’s mission to transform the treatment of solid tumors with a completely non-invasive technology that harnesses focused ultrasound to mechanically liquefy and destroy targeted tissue, reducing the risk of many complications and side effects associated with surgery, radiation, and other common therapies. “This submission is an important milestone in expanding histotripsy beyond the liver and into the kidney, an area where patients and physicians are s
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