MA-ABIOMED
15.12.2020 14:05:11 CET | Business Wire | Press release
Abiomed (NASDAQ: ABMD) announces the achievement of two milestones in the development of small bore access for the Impella heart pump. The Impella ECP heart pump has completed the first stage in its U.S. Food and Drug Administration (FDA) early feasibility study (EFS) and the FDA has granted 510(k) clearance to the Impella XR sheath.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201215005395/en/
The Impella XR sheath is a low-profile sheath that expands and recoils, allowing for small bore access and closure with the Impella 2.5 heart pump. It inserts at 10 French (Fr) and the flexible, nitinol braids momentarily expand during Impella delivery then recoil, simplifying access for complex interventions. The Impella XR sheath is intended to produce less trauma at the arterial access site compared to large bore sheaths.
The Impella XR sheath has been studied in patients outside of the United States on multiple occasions. The first patient in the U.S. is expected during Q4 of fiscal year 2021.
Additionally, Abiomed has successfully completed the first stage of the EFS of Impella ECP by enrolling and treating five patients. Impella ECP is the world’s smallest heart pump. It measures 9 Fr in diameter upon insertion and removal from the body. Once in the body, it expands to support the heart’s pumping function, providing peak flows greater than 3.5 L/min.
The prospective, multi-center, non-randomized EFS is designed to allow Abiomed, study investigators, and the FDA to make qualitative assessments about the safety and feasibility of Impella ECP use in high-risk percutaneous coronary intervention (PCI) patients. Abiomed will now submit data to the FDA and request to move to a second stage of the study with expanded enrollment.
“These milestones are important steps toward the fulfillment of Abiomed’s vision of creating an innovative portfolio of products that are smaller, smarter and more connected,” said Chuck Simonton, MD, Abiomed’s chief medical officer. “Design innovations like Impella ECP and Impella XR sheath will allow for a smaller access site with Impella, which will continue to drive better patient care and outcomes.”
Impella ECP is available for investigational use only and is not approved for use outside of clinical studies.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com .
ABOUT IMPELLA XR SHEATH
The Impella XR Sheath set is intended for use for the percutaneous introduction of the Impella 2.5 Catheter and ancillary devices.
ABOUT IMPELLA ECP
CAUTION: Impella ECP is an investigational device, limited by federal law to investigational use only.
ABOUT IMPELLA HEART PUMPS
The Impella 2.5® and Impella CP® devices are U.S. FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI), such as stenting or balloon angioplasty, to reopen blocked coronary arteries.
The Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, Impella LD®, and Impella 5.5® with SmartAssist® are U.S. FDA approved to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. Forward-looking statements are subject to risks and uncertainties such as those described in Abiomed's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201215005395/en/
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
4th Digital Engineering Awards Celebrate Global Innovators, AI Trailblazers: Herald the Rise of Engineering Intelligence14.3.2026 17:46:00 CET | Press release
Developed in association with ISG and CNBC-TV18, the fourth edition draws more than 250 nominations from 90+ global companies The Digital Engineering Awards concluded its fourth edition at Boston, Massachusetts on Thursday, honoring technology pioneers and organizations for their contributions to technology solutions and AI advancements. The gala night presented by L&T Technology Services (BSE: 540115, NSE: LTTS) along with ISG as the knowledge and research partner and CNBC-TV18 as the media partner, hosted both industry leaders and individual changemakers from 17 countries across North America, Europe, and the rest of the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260314443410/en/ The 4th edition of the Digital Engineering Awards, in association with ISG, CNBC-TV18 and L&T Technology Services, drew more than 250 nominations from 90+ global companies A total of 258 nominations from leading organizations and engine
Venture Global Announces Final Investment Decision and Financial Close for Phase 2 of CP2 LNG13.3.2026 15:23:00 CET | Press release
$8.6 billion project financing for CP2 Phase 2 brings project’s total financing to $20.7 billionProject expected to make Venture Global the largest exporter of US LNGUnprecedented milestone of five FIDs in less than 7 years, with over $95 billion in capital markets transactions Today, Venture Global, Inc. (NYSE: VG) is announcing a final investment decision (FID) and successful closing of an $8.6 billion project financing for the second phase of the company’s third project, Venture Global CP2 LNG (CP2). When combined with the Phase One financing for CP2 announced July 2025, this milestone represents the largest standalone project financing in the U.S. bank market.The transaction garnered enormous interest from the world’s leading banks, resulting in over $19 billion of commitments for Phase Two in addition to the previous $34 billion of commitments for Phase One, and required no outside equity investment. “We are extremely proud to have taken FID on the second phase of CP2, our third g
NIQ Launches Beta of New AI-Powered Analytical Capabilities in Ask Arthur13.3.2026 12:00:00 CET | Press release
AI-guided analysis helps brands and retailers turn data into decision-ready insights NIQ (NYSE: NIQ), a global leader in consumer intelligence, has launched new AI-powered analytical capabilities in beta within Ask Arthur on the NIQ Discover platform. The expanded experience guides users through end-to-end analysis—helping them identify what matters in the data, understand why trends are occurring, and turn insights into clear, shareable narratives with recommended next steps. As organizations navigate increasing data complexity, the ability to move quickly from insight to action has become essential. Ask Arthur helps shorten analytical processes that once took days or weeks into minutes by surfacing the key drivers behind performance changes and generating decision-ready insights directly within Discover. By connecting analysis, explanation, and storytelling in a single experience, users can move seamlessly from understanding what is happening in the data to determining what to do nex
Reply at NVIDIA GTC: Digital Twins and Physical AI Driving the Next Stage of Industrial Value Creation13.3.2026 11:24:00 CET | Press release
Reply [EXM, STAR: REY] will be present at NVIDIA GTC from 16 to 19 March 2026 in San Jose, California, showcasing how companies can optimise production and logistics processes, scale robotics and sustainably increase industrial performance using digital twin technology and physical AI. The conference is regarded as the most important international meeting point for AI developers, researchers and decision makers. This year, more than 30,000 participants from over 190 countries are expected to attend. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260313000399/en/ By attending NVIDIA GTC, Reply is showcasing how digital simulation and physical automation are already being integrated in practice. Projects for the Otto Group and the industrial edge domain show how physical AI and precise digital twins work together to create new opportunities for industrial value generation. The focus will be on two concrete use cases that demon
Klarna Board Chair Michael Moritz Acquires 3.47 Million Shares for $50 Million13.3.2026 11:05:00 CET | Press release
Klarna Group plc (NYSE: KLAR) today discloses the following transactions by the Chair of its Board of Directors and Chief Product & Design Officer, filed with the U.S. Securities and Exchange Commission on Form 3. Share Purchases Michael Moritz, Chairman, through an associated entity, purchased 3,472,845 ordinary shares between March 3 and March 11, 2026, at an aggregate consideration of $49,913,138.73. David Fock, Chief Product & Design Officer, purchased 27,000 ordinary shares on March 9, 2026, for an aggregate consideration of $388,552.14. Share Sales David Sandström, Chief Marketing Officer, sold 32,703 shares on March 9, 2026, pursuant to a Rule 10b5-1 trading plan, established in 2025. David Sykes, Chief Commercial Officer, sold 23,799 shares on March 13, 2026, pursuant to a separately established Rule 10b5-1 trading plan, established in 2025. Form 3 filings for all transactions are available on the SEC's EDGAR database atwww.sec.gov. Forward-Looking Statements This press release
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