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
Angelalign Technology (6699.HK)Releases 2025 Results: Passion for Clinical Excellence Drives Worldwide Growth27.3.2026 20:56:00 CET | Press release
Angelalign Technology Inc. (6699.HK) (“Angel” or the “Company”) released its financial results for fiscal year 2025. During the reporting period, the Company continued to do well in both the global and China markets. Total case volume was 532,400, which increased 48.1%, revenue was USD 370.3 million, which increased 37.8%, and adjusted net profit was USD 43.8 million, which increased 63.0%. The results were driven by Angel’s passion for clinical excellence and its open and inclusive culture that empowers talented people to work together to meet customer needs, the Company said. Fox Hu, CEO of Angel, stated: “The clear aligner industry is complex and multidisciplinary. It requires top-tier technical and operational talent along with seamless collaboration among professionals from diverse geographies. Angel’s open and inclusive culture attracts professionals who share a passion for clinical excellence and a dedication to bringing outstanding products and services to customers. This melti
Axway Positioned as a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment27.3.2026 18:46:00 CET | Press release
Axway, a 74Software company (Euronext: 74SW) and global leader in federated API management and enterprise integration, has been named a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment.1 Axway Amplify securely connects, orchestrates, and automates data integration. Organizations in financial services, manufacturing, healthcare, and other industries rely on Amplify to modernize integrations and confidently unlock data to deliver superior digital services faster. The report notes: “The platform benefits from Axway’s long-standing experience in B2B integration, secure file transfer, and legacy connectivity, providing differentiated capabilities for organizations that need to expose and control APIs around core systems that are not cloud-native.”1 This multi-pattern expertise in security, integration, and federated governance — built during the early phases of the API-driven digital transformation — becomes especially critical as enterprises seek to govern dat
Credit Derivatives Determinations Committees Membership applications for 202627.3.2026 17:30:00 CET | Press release
DC Administration Services, Inc. (DCAS) would like to invite all interested Members of ISDA to apply for a position as a member of the Credit Derivatives Determinations Committees. There is a separate Determinations Committee for each of the relevant regions. Members of ISDA may apply for membership as either a Dealer Member of the Determinations Committees or a Non-Dealer Member of the Determinations Committees (as applicable). Parties wishing to apply for such a position should carefully review and submit either an executed Dealer Participation Letter (for a prospective Dealer Member) or an executed Non-dealer Committee Participation Letter (for a prospective Non-Dealer Member) by 5pm (New York time) on Friday, April 3, 2026. CCPs may also apply to participate as a CCP Member by submitting a Participating CCP Institution Letter. For more information on the process and to download the form of the relevant letter, please visit https://www.cdsdeterminationscommittees.org/about-dc-commit
Andersen Consulting indgår samarbejdsaftale med Solutia27.3.2026 15:22:00 CET | Pressemeddelelse
Andersen Consulting udvider sin tilstedeværelse i Spanien gennem en samarbejdsaftale med Solutia, en virksomhed med speciale i løsninger inden for arbejdsmiljø og sundhed samt rekruttering inden for life science- og sundhedssektoren. Solutia blev stiftet i 2014 og tilbyder omfattende tjenester og rådgivning med fokus på sunde arbejdsmiljøer, sygefravær, outsourcing af sundhedsydelser og uddannelse til organisationer på tværs af alle sektorer. Virksomheden leverer også rekrutterings- og executive search-løsninger med fokus på life science, tekniske fagfolk samt mellem- og topledelse samt dybdegående ekspertise inden for medicinal-, bioteknologi-, medico- og sundhedsindustrien. Ved hjælp af datadrevne og skræddersyede løsninger hjælper Solutia virksomheder med at optimere medarbejdereffektiviteten og tiltrække specialister. "Vores mål er at forbedre, hvordan organisationer tiltrækker, udvikler og leder medarbejdere i et stadig mere komplekst miljø," udtalte Cesar Castel, administrerende
Klarna Partners With EuroParcs to Offer Flexible Payments for Holiday Park Stays Across Europe27.3.2026 15:04:00 CET | Press release
Klarna, the global digital bank and flexible payments provider, today announces a new partnership with EuroParcs, one of Europe's fastest-growing holiday park operators. The collaboration gives holidaymakers in Germany, the Netherlands, Belgium, and Austria more flexibility in how they pay for their getaway. Guests booking through EuroParcs can now choose from a range of Klarna payment options tailored to their market: Germany & Austria: Pay in Full, Pay in 30 Days, Pay in 3, and Financing Netherlands: Pay in Full, Pay in 30 Days, and Pay in 3 Belgium: Pay in Full and Pay in 30 Days Nicole Defren, Head of Europe at Klarna, says: "Booking a holiday should feel exciting, not complicated – and that includes how you pay for it. With Klarna, EuroParcs guests can choose the payment option that suits them best, whether that's paying upfront, in a few weeks, or spreading the cost over time. From a cosy chalet on the Veluwe to a luxury villa in the Austrian Alps, we're making it easier for fami
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
