ABIOMED-EUROPE-GMBH
4.3.2021 15:02:10 CET | Business Wire | Press release
Following consultation with its notified body, MEDCERT GmbH, Abiomed is introducing the single access procedure with Impella CP introducer sheaths for the treatment of heart disease in Europe.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210304005331/en/
At Abiomed's European headquarters in Aachen, Germany, Impella heart pumps have been developed and produced for more than 20 years to stabilize and recover the human heart. The single access procedure enables the treating physician not only to place Impella heart pumps in the ventricle via the 14 French Impella CP introducer sheaths, but also to insert other catheters and introducer sheaths. Thus, cardiac interventions such as percutaneous coronary interventions can also be performed via the 14 French Impella CP introducer sheaths.
The single access procedure is already practiced in the U.S., where it was incorporated into Impella CP’s U.S. labeling in January 2020. The confirmation given by MEDCERT GmbH for the single access procedure now gives cardiologists in Europe the option of performing interventional treatments for severe cardiac diseases via just one access site. This method may be beneficial for patients with limited vascular access and may reduce potential complications using only one access site.
As a notified body, MEDCERT Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH is an organization designated by Germany, as an EU member state, to determine whether medical devices comply with European directives and regulations. MEDCERT GmbH has now confirmed to Abiomed that the single access procedure is possible in Europe as well.
More than 170,000 patients worldwide have been treated with Abiomed's small Impella heart pumps. Impella heart pumps promote heart recovery by taking over partial or full pump function of the heart, depending on the pump type, and relieving the ventricle, thereby supporting blood circulation, stabilizing patients' hemodynamics and improving blood supply to end organs. In this way, Impella heart pumps can promote the regeneration of the heart muscle, and enable patients to enjoy an improved quality of life. The heart pumps are used in emergency medicine as well as in complex coronary interventions.
ABOUT IMPELLA HEART PUMPS
Impella 2.5® , Impella CP® , Impella CP® with SmartAssist® Impella 5.0® , Impella LD® and Impella 5.5® with SmartAssist® heart pumps are CE certified and FDA approved for the treatment of heart attack patients with cardiogenic shock. Impella heart pumps assist in restoring cardiac function so the patient can leave the hospital with their own heart. The Impella 2.5 and Impella CP heart pumps are also approved in certain cases to treat patients with advanced heart failure who need to undergo elective percutaneous coronary interventions, e.g. stent implantation or balloon angioplasty, to reopen blocked coronary arteries. The right ventricular heart pump, Impella RP® , is approved for the treatment of certain patients with right heart failure. For more information about Impella heart pumps and their approved indications, as well as important safety and risk information associated with the use of these devices, please refer to the Instructions for Use or visit: www.heartrecovery.de .
ABOUT ABIOMED
Abiomed Europe GmbH, Aachen / Germany, as affiliate of Abiomed Inc. headquartered in Danvers, Massachusetts, USA, is a leading medical technology company in the field of circulatory support. Our products aim to enable heart recovery by improving blood circulation and/or heart pump function. For more information, visit www.heartrecovery.de .
Abiomed, Impella, Impella 2.5, Impella 5.0, Impella 5.5, Impella LD, Impella CP, Impella RP, SmartAssist and Impella Connect are registered trademarks of Abiomed, Inc. and registered in the U.S. and certain other countries.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements, including with respect to Abiomed's development of existing and new products, the Company's commercial growth, future business opportunities and pending regulatory approvals. The Company's actual results may differ materially from those anticipated in these forward-looking statements due to a number of factors, including uncertainties related to the scope, extent and duration of the impact of the COVID-19 pandemic, development, testing and related regulatory approvals, including the possibility of future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological changes, governmental requirements, litigation, future capital requirements and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission (SEC), including its most recent Annual Report on Form 10-K and subsequent filings with the SEC. Readers of this press release are advised not to evaluate forward-looking statements, which reflect information available only as of the date of this release, as reliable information. The Company is under no obligation to release updates to these forward-looking statements to reflect events or circumstances occurring after the date of the release or as a result of the impact of unforeseen events.
The source language in which the original text is published is the official and authorized version. Translations are provided for better understanding. Only the language version published in the original is legally valid. Therefore, match translations with the original language version of the publication.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210304005331/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
STARTEEPO Invest Announces 5% Stake in Xerox Holdings Corporation15.5.2026 18:15:00 CEST | Press release
STARTEEPO Invest (“STARTEEPO”), an alternative investment fund focused on public equity opportunities, today announced that it has acquired a significant ownership position in Xerox Holdings Corporation (“Xerox” or the “Company”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260515594020/en/ As of the date of this release, STARTEEPO and its affiliates beneficially owns 6.6 million shares of Xerox (excluding options), representing approximately 5.05% of the Company’s outstanding common stock. STARTEEPO has filed a Schedule 13D with the U.S. Securities and Exchange Commission (the “SEC”) providing additional details regarding its investment. Investment Perspective STARTEEPO believes that Xerox represents an interesting investment opportunity supported by a combination of balance sheet initiatives, ongoing operational improvements, and its position within a changing and consolidating industry. In STARTEEPO’s view, the Company
NTT DATA Announces Intent to Acquire WinWire to Scale Enterprise AI Adoption and Accelerate Industry Transformation with Microsoft15.5.2026 16:00:00 CEST | Press release
Accelerates AI‑driven transformation through expanded agentic AI and data engineering capabilities that underpin NTT DATA’s AI strategy Adds 1,000 Azure engineers and AI specialists to scale cloud and AI delivery capabilities Advances NTT DATA’s North America leadership position, scaling industry aligned AI led innovation across its cloud services and Microsoft Business Unit Builds on NTT DATA’s position as the fastest-growing Microsoft GSI partner, accelerating co-innovation in enterprise AI NTT DATA, a global leader in AI, digital business and IT services, today announced it has signed a definitive agreement to acquire WinWire,an award-winning Microsoft partner specializing in Agentic AI, AI on Azure, data engineering and cloud-native development as foundational capabilities for enterprise AI. The acquisition strengthens NTT DATA’s position as a trusted partner to help organizations move beyond experimentation to operationalize AI at scale. The acquisition further advances NTT DATA’s
NTT DATA Announces Intent to Acquire WinWire to Scale Enterprise AI Adoption and Accelerate Industry Transformation with Microsoft15.5.2026 16:00:00 CEST | Press release
Accelerates AI‑driven transformation through expanded agentic AI and data engineering capabilities that underpin NTT DATA’s AI strategy Adds 1,000 Azure engineers and AI specialists to scale cloud and AI delivery capabilities Advances NTT DATA’s North America leadership position, scaling industry aligned AI led innovation across its cloud services and Microsoft Business Unit Builds on NTT DATA’s position as the fastest-growing Microsoft GSI partner, accelerating co-innovation in enterprise AI NTT DATA, a global leader in AI, digital business and IT services, today announced it has signed a definitive agreement to acquire WinWire,an award-winning Microsoft partner specializing in Agentic AI, AI on Azure, data engineering and cloud-native development as foundational capabilities for enterprise AI. The acquisition strengthens NTT DATA’s position as a trusted partner to help organizations move beyond experimentation to operationalize AI at scale. The acquisition further advances NTT DATA’s
Experian Expands Agent Trust Partner Ecosystem with Akamai to Advance Trusted AI Driven Commerce15.5.2026 15:00:00 CEST | Press release
Collaboration strengthens secure, scalable agentic commerce and supports emerging Know Your Agent standards Experian today announced that Akamai Technologies has joined its growing partner ecosystem, designed to further advance secure, trusted AI driven commerce through the Experian Agent Trust™ framework, alongside partner Skyfire supporting emerging payment innovation. As AI agents begin to search, decide, and transact autonomously, they introduce a fundamental challenge for businesses: how to trust an action when it is no longer directly initiated by a human. Without a verified connection between humans and AI agents, autonomous commerce introduces new risks in fraud, misrepresentation, and unauthorized transactions. Experian Agent Trust is designed to address this challenge by establishing identity, accountability, and trust in agent driven interactions. “Trust, security, and performance must scale alongside the growing role of AI agents in digital commerce,” said Kathleen Peters,
The LYCRA Company and Dukane Advance Ultrasonic Bonding for Nonwovens at INDEX™ 2615.5.2026 14:00:00 CEST | Press release
LYCRA FUSION™ Fiber for Personal Care Applications Debuts The LYCRA Company, a global leader in innovative and sustainable fiber solutions for the personal care industry, and Dukane, a manufacturer of ultrasonic bonding technologies for the hygiene and nonwovens market, are showcasing their latest co-developed advances in ultrasonic bonding at INDEX™ 26, taking place in Geneva, Switzerland, from May 19–22. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260515514441/en/ Join The LYCRA Company and Dukane at INDEX™ 26 in Geneva, as they showcase their latest advances in ultrasonic bonding for nonwovens, including new LYCRA FUSION™ fiber for personal care that delivers superior snapback. Since 2014, both companies have collaborated to advance ultrasonic bonding solutions that help diaper manufacturers improve product softness, fit, and performance while reducing energy consumption, material waste, and maintenance costs. Ultrason
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
