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
Xsolla Launches Game Biz Institute, an Editorial Platform Where Industry Practitioners Explain the Business of Games27.8.2026 17:32:00 CEST | Press release
New Platform Pairs Independent Researchers and Industry Veterans with Xsolla Experts to Unpack Direct-to-Player Commerce, Monetization, Payments, and Player Retention Xsolla, a global commerce company, today announced the launch of Game Biz Institute (GBI), an editorial platform where named industry practitioners and researchers examine the commercial layer of games: direct-to-player distribution, payments, monetization, user acquisition, and retention. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260827362663/en/ Graphic: Xsolla Game design has a curriculum. The business of games does not. Engines, pipelines, production, and narrative are taught at hundreds of universities, while the commercial machinery that determines whether good work becomes a durable company is still learned through expensive trial and error, usually after the decisions that mattered have already been made. GBI was built to close that gap by publishi
Star Wars Zero Company™ Now Available On PC, PlayStation 5 and XBOX Series Consoles27.8.2026 17:00:00 CEST | Press release
Bit Reactor’s Debut Title Combines Tactical Depth and Cinematic Elegance for a New Star Wars StoryWatch the Final Trailer to Witness What’s at Stake in the Galaxy Electronic Arts Inc. and Bit Reactor, in collaboration with Lucasfilm Games, announced today that Star Wars Zero Company™, a single-player turn-based tactics game set in the twilight of the Clone Wars™, is now available for PC via the EA app, Steam, and Epic Games Store, and PlayStation®5 and XBOX Series consoles. In Star Wars Zero Company, former Republic officer Hawks and Zero Company, an elite squad of unconventional professionals for hire, are recruited for an operation by Republic Intelligence. From ex-nobles to ex-cons, they now share one mission: Stop the Infinite Coil, a Separatist-aligned cult, and their leader Kundri Fathom before the deadly Shadow Plague consumes the galaxy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260827012810/en/ https://www.yout
Rehlko Joins Wisconsin Data Center Coalition as Newest Energy Resilience Member, Reinforcing Its Role at the Center of AI and Digital Infrastructure Growth27.8.2026 15:15:00 CEST | Press release
Global Energy Resilience Leader Reinforces Its Role at the Center of AI and Digital Infrastructure Growth Through Mission-Critical Power Expertise Rehlko, a global industrial energy resilience platform providing custom-engineered, integrated power solutions for mission-critical infrastructure worldwide, today announced it has joined the Wisconsin Data Center Coalition (WIDCC) as the organization's newest energy resilience member. The membership reflects Rehlko's commitment to advancing Wisconsin's role as a leader in responsible AI infrastructure development, built on reliable and scalable power. Rapid growth in hyperscale and enterprise data center investment is reshaping markets across the world, and Rehlko is building the power infrastructure that makes it possible. Sitting at the intersection of the structural forces driving AI infrastructure expansion, grid reliability, and accelerating electrification, Rehlko brings more than a century of engineering depth and lifecycle capabilit
GenNx360 Capital Partners Closes Fourth Flagship Fund at $865 Million27.8.2026 14:30:00 CEST | Press release
Fund IV success is the result of two decades of proven performance backing lower middle market industrial services and business services companies GenNx360 Capital Partners (“GenNx360” or “the Firm”), a New York City-based private equity firm investing in U.S. lower middle market industrial services and business services companies, today announced the successful closing of GenNx360 Capital Partners IV, L.P. (“Fund IV” or “the Fund”), with $865 million in commitments, exceeding its target. Fund IV is the largest fund raised in GenNx360’s history. Fund IV was supported by a diverse group of existing and new investors including leading pensions, asset managers, insurance companies, foundations, and family offices, reflecting conviction in the firm’s disciplined investment approach, operational value creation model, and tenured, diverse team. Fund IV will continue GenNx360’s differentiated strategy of partnering with lower middle market founders and management teams to scale essential serv
Alipay Ant Forest Turns 700 Million Users’ Daily Green Actions into 700 Million Trees Over a Decade of Technology-enabled Environmental Program27.8.2026 14:02:00 CEST | Press release
Alipay Ant Forest, Ant Group’s green initiative that encourages people to participate in environmental protection through simple, everyday low-carbon actions, today announced that more than 700 million users across China have joined the program as of August 2026. Together, they have helped support the planting of over 700 million trees, contributing to ecological restoration efforts in some of China’s most arid and environmentally fragile regions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260827995848/en/ Before (2019) and after (2026) comparison of Ant Forest Project No. 464 in Inner Mongolia. Launched in 2016 within the Alipay app, Ant Forest transforms individual environmental choices into collective climate action. When users make greener lifestyle choices, such as taking public transportation, cycling, paying bills online to avoid paper invoices, or choosing digital services, they earn virtual “green energy points”
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