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
New Summer Program from Corona Invites the World to Experience “This Is Living”11.5.2026 10:00:00 CEST | Press release
The brand moves from inspiration to action with “Living Is Calling,” a campaign to enjoy the outdoors through a global partnership with Tripadvisor Today, Corona, the world’s most valuable beer brand*, unveils “Living is Calling” – a new global call to action inviting consumers to step outside and live life to the fullest this summer. As a powerful extension of its “This Is Living” platform, the new campaign invites the world to put living first through a partnership with Tripadvisor featuring over 300,000 experiences, and a new global film. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511429135/en/ “For the past 100 years, Corona has inspired the world to come outside and feel more moments of ‘This Is Living,’ and we believe the next chapter is about helping people take action and embrace the outdoors,” said Clarissa Pantoja, Global Vice President of Corona. “‘Living is Calling’ is our worldwide call to action, and we’
Braskem Celebrates Naming of Beautiful Future and Blooming Future, Next‑Generation Tankers for Cleaner Global Trade11.5.2026 10:00:00 CEST | Press release
Beautiful Future and Blooming Future combine cutting‑edge efficiency and emissions‑reduction technologies to support more responsible global trade. Braskem (B3: BRKM3, BRKM5, and BRKM6; NYSE: BAK; LATIBEX: XBRK), the largest polyolefins producer in the Americas and global leader in the production of biopolymers on an industrial scale announces today that Braskem Trading & Shipping (BT&S) has reached a major milestone in its fleet modernization and sustainability journey with the naming of Beautiful Future and Blooming Future, next‑generation chemical and product oil tankers designed to move essential raw materials more efficiently and with a significantly lower environmental footprint. Both vessels were formally named at a ceremony in China on May 8. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511112306/en/ Beautiful Future Beautiful Future and Blooming Future are LR1 (Long Range 1) vessels that will transport naphtha,
Kiabi Selects Navan to Centralise Global Travel Program11.5.2026 09:00:00 CEST | Press release
Fashion retailer targets high employee adoption and efficiency with AI-powered travel platform Navan (NASDAQ: NAVN), the global AI-powered business travel and expense platform, today announced it has been selected by Kiabi, the French multinational fashion retailer, to consolidate its global travel with one unified platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511547434/en/ Fashion retailer targets high employee adoption and efficiency with AI-powered travel platform To support its workforce of nearly 10,000 “Kiabers,” the retailer required a solution capable of providing an easy-to-use travel platform. Navan was selected due to its intuitive AI-powered interface and ability to integrate with Kiabi’s travel policies directly in-app. “Managing travel was becoming an administrative burden that slowed our teams down,” said Denise Maurice, Indirect Procurement Director at Kiabi. “We wanted to give our ‘Kiabers’ the
Owl Labs partners with Westcoast to expand access to seamless hybrid meeting experiences in the UK and Ireland11.5.2026 09:00:00 CEST | Press release
Partnership aims to reduce the ‘meeting tax’ by expanding access to Owl Labs products through Westcoast’s extensive distribution network Owl Labs, a global leader in AI-powered, 360-degree video conferencing solutions, today announced a new UK and Ireland distribution partnership with Westcoast Limited, one of the country’s largest and most trusted IT distributors. The agreement will see Westcoast distribute the full range of Owl Labs’ award-winning Meeting Owl and Owl Bar products across the UK and Ireland, providing greater choice, availability, and dedicated support for resellers and end customers navigating the demands of hybrid work. The partnership aims to address the technical setup challenges that plague meetings across the UK. Owl Labs’ recent State of Hybrid Work report found that nearly 8 in 10 workers (79%) lose time in meetings due to technical difficulties such as connecting to a meeting or setting up a camera. By making Owl Labs’ solutions simpler to source, deploy and s
Fujirebio Announces CE Marking of the Fully Automated Lumipulse® G pTau 217 Plasma Assay11.5.2026 09:00:00 CEST | Press release
H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that Fujirebio Europe N.V. has obtained a CE certificate of the Lumipulse G pTau 217 Plasma assay under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). This CLEIA (chemiluminescent enzyme immunoassay) test allows for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human plasma (K2EDTA). “With Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma now CE‑marked on our LUMIPULSE G platform, we are advancing a new era of neurology diagnostics—one where blood‑based biomarkers enable earlier, broader, and more accessible insights into Alzheimer’s disease and neurodegeneration.” said Christiaan De Wilde, CEO at Fujirebio Europe N.V. “By delivering fully automated and scalable solutions, we are helping clinicians move decisively toward more timely and informed decision‑making. This milestone underscores our long‑term vision to reimagine the diagnostic
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