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
Xsolla and the Dubai Films and Games Commission Create a Strategic Partnership to Connect Dubai-Based Developers to Global Markets21.5.2026 05:16:00 CEST | Press release
Multi-Year Agreement Creates Opportunities to Build All The Things for Video Games in Dubai and MENA Xsolla, a leading global video game commerce company, and the Dubai Games Commissioner, in coordination with the Dubai Films and Games Commission, announced a multi-year strategic partnership to accelerate the development of the video game industry and expand commercial access for developers operating across the Middle East and North Africa. The announcement was made at GamesBeat Summit 2026 in Los Angeles, California. The partnership will unite Xsolla's global commerce infrastructure, including direct-to-consumer storefronts, intelligent payments across 1,000+ payment methods in 200+ geographies, and player engagement tools, with DFGC's mandate to establish Dubai as a world-class destination for video game development and publishing. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260520329315/en/ Xsolla and the DFGC partner
Marquee Brands Enters Strategic Partnership With DAMAC Group for a Majority Interest in Roberto Cavalli20.5.2026 20:30:00 CEST | Press release
The Partnership Positions Roberto Cavalli for a New Phase of Global Expansion and Omnichannel Growth Marquee Brands, the premier global brand management company and leading brand accelerator, today announced a definitive agreement for a majority interest in Roberto Cavalli, through a strategic partnership with DAMAC Group, the leading Dubai-based global conglomerate and luxury real estate developer. The transaction is expected to close in the second quarter of 2026, after which DAMAC Group will remain a significant shareholder. Founded in Florence in 1970, Roberto Cavalli the iconic luxury house celebrated for its avant-garde design and distinct Italian craftsmanship joins Marquee Brands’ portfolio of timeless global brands, including Martha Stewart, Laura Ashley, Sur La Table, BCBGMAXAZRIA and Stance. The addition of Roberto Cavalli further strengthens Marquee Brands’ position as a leader in the luxury and lifestyle sectors, bringing total portfolio-wide retail sales to approximately
Variational Secures ~$50M to Bring Liquidity from Traditional Markets To Crypto20.5.2026 19:07:00 CEST | Press release
Already powering $200B+ in crypto volume, Variational is using its zero-fee liquidity aggregation model to bring traditional markets on-chain. Variational, a protocol for on-chain derivatives trading, has announced a ~$50M Series A raise led by Dragonfly with support from Bain Capital Crypto, Coinbase Ventures, and other strategic investors. The funding coincides with the launch of the protocol’s first Real-World Asset (RWA) markets. This initial rollout allows traders to access perpetuals on select commodities alongside their crypto portfolio, laying the groundwork for Variational to route liquidity directly from traditional markets in the coming months. While the broader crypto industry is attempting to bootstrap RWA liquidity from scratch on isolated Central Limit Order Books (CLOBs), Variational introduces a fundamentally different architecture. Instead of starting new order books from scratch for each new market, Variational aggregates and routes liquidity from both existing tradi
EIG’s MidOcean Energy Announces $120m Investment from The Arab Energy Fund as Part of Equity Raise20.5.2026 17:29:00 CEST | Press release
MidOcean Energy (“MidOcean” or the “Company”), a liquefied natural gas (LNG) company formed and managed by EIG, today announced a $120 million equity investment from The Arab Energy Fund (‘’TAEF’’), a leading multilateral impact financial institution, as part of its current equity capital raise. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260520063539/en/ TAEF’s investment further strengthens MidOcean’s high-quality investor base and underscores continued strong interest in the Company’s strategy to build a diversified, resilient and long-life global LNG business. There is significant further momentum from additional investors currently in documentation, and MidOcean will continue to raise capital, with a cumulative target of up to $2 billion from new investors. R. Blair Thomas, MidOcean Chairman and EIG CEO, said: “We are delighted to welcome The Arab Energy Fund as a shareholder in MidOcean. Their significant expertise
TestMu AI Expands Real Device Testing With Multi-Language Playwright Support and Advanced Audio Testing for iOS20.5.2026 17:26:00 CEST | Press release
The latest updates enable Playwright automation across Java, Python, and C#, and introduce real-time audio injection capabilities on real iOS devices TestMu AI (formerly LambdaTest), the world’s first full-stack Agentic AI Quality Engineering platform, today announced two major enhancements to its Real Device Cloud: expanded support for Playwright automation across multiple programming languages and the introduction of Audio Injection and Live Audio Input capabilities for real iOS devices. These updates address a growing need for testing modern applications that are not only cross-platform but also increasingly multimodal, involving voice, audio, and real-time user interactions. With the latest release, TestMu AI now supports running Playwright tests on real devices using Java, Python, and C# in addition to existing capabilities. This allows enterprise teams to adopt Playwright within their preferred language ecosystems without being restricted to JavaScript-based workflows. As Playwri
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
