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
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
IMCAS 2026: Galderma Showcases the Latest Scientific Advances Behind the Industry’s Broadest Injectable Aesthetics Portfolio22.1.2026 07:00:00 CET | Press release
At IMCAS 2026, Galderma will present findings supporting Sculptra’s® regenerative properties and benefits on the body, including improving cellulite appearance, firmness, lift, projection, and contouring following its European Union (EU) Medical Device Regulation (MDR) certification, expanding its use to four body areas1-7 Multiple studies will reinforce the safety and efficacy of Galderma’s hyaluronic acid (HA) treatments range, including post-marketing data on Restylane® Shaype™ in shaping the chin, Restylane Lyft™ in improving jawline definition, Restylane Skinboosters™ in smoothing fine lines and wrinkles in the décolletage and Restylane Volyme™ in correcting hollowing of the temples8-11 New data on the innovative neuromodulator Relfydess™ (RelabotulinumtoxinA) will reinforce its rapid onset as early as Day 1 and sustained efficacy through six months for frown lines and crow’s feet12 As a leader in injectable aesthetic innovation, Galderma will showcase its superior science and edu
WEF26: Saudi Arabia Leads New Global Push to Protect Coral Reefs, Unlock AI Potential22.1.2026 05:52:00 CET | Press release
The Saudi delegation to the World Economic Forum (WEF) Annual Meeting 2026 today observed a series of announcements aimed at addressing urgent global challenges. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260121465066/en/ Her Royal Highness Ambassador Reema Bandar Al-Saud, Ambassador of the Kingdom of Saudi Arabia to the United States of America, announced at the World Economic Forum Annual Meeting that Saudi Arabia will host the first Global Coral Reef Summit in 2026 (Photo: AETOSWire) Her Royal Highness Ambassador Reema Bandar Al-Saud, Ambassador of the Kingdom of Saudi Arabia to the United States of America, announced that Saudi Arabia will host the first Global Coral Reef Summit in 2026, bringing together global leaders, scientists, and investors to drive solutions for the protection and recovery of coral reef ecosystems. The summit will address key challenges and policy and regulatory gaps, develop science-based sol
BitGo Holdings Announces Pricing of Initial Public Offering22.1.2026 03:38:00 CET | Press release
BitGo Holdings, Inc. (“BitGo”), the digital asset infrastructure company, announced today the pricing of its initial public offering of an aggregate of 11,821,595 shares of Class A common stock at a price to the public of $18.00 per share. The offering consists of 11,026,365 shares of Class A common stock being offered by BitGo and 795,230 shares of Class A common stock being offered by certain existing stockholders of BitGo. BitGo will not receive any proceeds from the sale of the shares by the selling stockholders in connection with the offering. In connection with the offering, BitGo has granted the underwriters a 30-day option to purchase up to an additional 1,770,000 shares of its Class A common stock at the public offering price, less underwriting discounts and commissions. The shares are expected to begin trading on the New York Stock Exchange on January 22, 2026 under the ticker symbol "BTGO" and the offering is expected to close on January 23, 2026, subject to customary closin
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