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
Murata Launches Ultra-Low Power AMR Sensors to Boost Battery Life in Healthcare and Wearables Devices27.4.2026 04:00:00 CEST | Press release
Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) has commenced mass production of its MRMS166R and MRMS168R anisotropic magnetoresistance (AMR) sensors for healthcare, wearable, and IoT devices. The MRMS166R is the first AMR sensor to combine an average current consumption of 20 nA with operation from a 1.2 V supply, enabling extended battery life in coin cell-powered systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260413296947/en/ [Murata Manufacturing Co., Ltd.] AMR sensor The devices are solid-state magnetic sensors used for switching applications. They detect the presence or absence of a magnetic field and generate an output signal that system logic uses to control functions such as transitions between active and sleep modes. This enables contactless switching without mechanical components, improving reliability, and supporting sealed, miniaturized designs. Automatic switching between active and
Sun Pharma signs Definitive Agreement to Acquire Organon27.4.2026 01:51:00 CEST | Press release
Organon stockholders to receive US$ 14.00 per share in cashThe deal values Organon at EV of US$ 11.75 billionCombined Business leverages complementary portfolios and global scale for sustained long‑term value creation Sun Pharmaceutical Industries Limited(Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) (together with its subsidiaries and/or associated companies, “Sun Pharma”) and Organon & Co. (NYSE: OGN) (“Organon”) today announced that they have entered into a definitive agreement under which Sun Pharma will acquire all outstanding shares of Organon for US$ 14.00 per share in an all‑cash transaction with an enterprise valuation of US$ 11.75 billion. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260426881370/en/ Organon is a global healthcare company formed through a spinoff from Merck, known as MSD outside of the United States and Canada, in 2021. Organon has a legacy of deep trust and strong brand equit
Andersen Global udvider sin tilstedeværelse i Afrika med lanceringen af medlemsfirma i Cameroun26.4.2026 20:56:00 CEST | Pressemeddelelse
Andersen Global træder ind på det camerounske marked, idet Phoenix Advisory bliver medlemsfirma og overgår til Andersen-brandet. Andersen in Cameroun er et specialiseret rådgivningsfirma, der leverer strategiske, erhvervsmæssige, finansielle og operationelle rådgivningsydelser til organisationer i forskellige vækstfaser. Firmaet er grundlagt af fagfolk med erfaring fra store internationale organisationer og kombinerer et stærkt lokalt og centralafrikansk funderet kendskab til forretningsmæssige, juridiske og skattemæssige regler med en skræddersyet tilgang, der har til formål at skabe konkrete og målbare resultater for klienterne. "Overgangen til Andersen-brandet afspejler vores engagement i at vokse sammen med vores kunder og imødekomme stadig mere komplekse behov," udtalte administrerende partner Albert Désiré Zang. "Vi tror på, at langsigtet succes skabes gennem tillid, kvalitet og vedvarende support. At blive et medlemsfirma styrker vores evne til at levere gennemtænkte, bæredygtig
PMCOrganometallix Announces Price Increase on All Products24.4.2026 22:55:00 CEST | Press release
Due to significant changes in market conditions, PMC Organometallix, Inc. announces that effective May 1, 2026, or as contracts permit, prices across all product lines globally will increase by 10-25%. This adjustment is driven by sustained cost pressures from key inputs including rising raw material costs and escalating freight and logistics expenses. While the company has been absorbing these increases, the current economic environment brought on by the geopolitical crisis of the Iran conflict requires this adjustment to continue providing the high-quality, consistent materials and supply reliability that customers expect. PMC Organometallix will implement these changes in a transparent, collaborative manner and values your partnership while navigating these economic challenges. Customers with questions or to discuss a specific situation should contact their account representative. About PMC Group PMC Group is a growth-oriented, diversified, global chemicals and plastics company deli
Frankfurt Higher Regional Court upholds BESREMi® arbitral award in favor of AOP Health24.4.2026 18:52:00 CEST | Press release
Today, the Higher Regional Court of Frankfurt upheld the February 20251 partial final ICC arbitral award in favor of AOP Orphan Pharmaceuticals GmbH (“AOP Health”) in its dispute with PharmaEssentia Corp. (“PharmaEssentia”). The ruling confirms the award which found the Taiwanese company to be liable for certain damages. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260424005227/en/ Portrait Dr. Rudolf Widmann, Founder AOP Health Credit: AOP Health/Daniel Ospelt Dr. Rudolf Widmann, one of the two founders of AOP Health, explains: “We very much welcome the Frankfurt Higher Regional Court’s decision that confirms our position. In the interest of our patients, we are dedicated to maintaining stable and sustainable access to BESREMi® and to responsibly navigating future challenges.” The Product in Dispute The conflict centers around BESREMi® (ropeginterferon alfa-2b), a product launched in 2019 and developed by AOP Health into
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