Business Wire

ABIOMED-EUROPE-GMBH

4.3.2021 15:02:10 CET | Business Wire | Press release

Share
MEDCERT Enables the Use of the Single Access Procedure with Impella CP Introducer Sheaths in Europe

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.

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

Royal London Asset Management Expands Relationship with SS&C to Service New Australian Funds27.5.2026 00:00:00 CEST | Press release

SS&C Technologies Holdings, Inc. (Nasdaq: SSNC) today announced that Royal London Asset Management, a leading U.K. fund management company, has extended its relationship with SS&C. SS&C Global Investor & Distribution Solutions will provide fund administration and unit registry services for its new range of Australian active funds, including: Royal London Global Equity Diversified Fund Royal London Global Equity Enhanced Fund Royal London Global Equity Select Fund Royal London Short Duration Global High Yield Bond Fund RLAM is part of Royal London, the U.K.’s largest mutual life, pensions and investment company. SS&C services approximately £72bn in assets under management across its U.K. fund range. Equity Trustees will serve as the Responsible Entity for RLAM’s new funds, which have launched with around AUD $1 billion in AUM. The unit trusts are structured as feeder funds, providing investors with indirect exposure to RLAM’s range of Dublin-domiciled Undertakings for Collective Investm

SLB Announces Date for Second-Quarter 2026 Results Conference Call26.5.2026 19:00:00 CEST | Press release

SLB (NYSE: SLB) will hold a conference call on July 24, 2026, to discuss the results for the second quarter ending June 30, 2026. The conference call is scheduled to begin at 9:30 a.m. U.S. Eastern time and a press release regarding the results will be issued at 7:00 a.m. U.S. Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (800) 715-9871 within North America or +1 (646) 307-1963 outside of North America approximately 10 minutes prior to the start of the call and the access code is 3440360. A webcast of the conference call will be broadcast simultaneously at https://events.q4inc.com/attendee/157027565 on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call, a replay will be available at www.slb.com/irwebcast until July 31, 2026, and can be accessed by dialing +1 (800) 770-2030 within North America or +1

Alipay Launches Next-Generation AI Payment Infrastructure, Debuts AI Wallet and Token Pay to Power Agentic Economy26.5.2026 17:20:00 CEST | Press release

Alipay today introduced its full-stack AI payment solution to partners across industries, ranging from AI companies to traditional retailers, and debuted two new services — the world’s first AI Wallet and Token Pay — to support the agentic economy’s rapid growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260526337824/en/ Alipay Unveils Next-generation AI Payment Infrastructure This launch extends Alipay's next-generation AI payment infrastructure, building on its consumer-facing product Alipay AI Pay and its business-facing AI payment processing product. “While the essence of commerce remains unchanged in the age of AI, the emergence of AI agents is reshaping everything. Drawing on 22 years of technological expertise and commercial know-how, Alipay is building a new generation of AI payment services to accelerate the growth of the agentic commerce ecosystem,” said Cyril Han, CEO of Ant Group. AI Wallet: Giving Users Vis

Daiichi Sankyo Europe Reaffirms Commitment to Patient-Centred Care with Extensive Data Showcase at EAS Congress 202626.5.2026 17:00:00 CEST | Press release

Presentations at the 94th European Atherosclerosis Society (EAS) Congress highlight the breadth of evidence for bempedoic acid across a wide range of patient subgroups and background therapies. Real-world data from the MILOS study across multiple European cohorts demonstrate consistent effectiveness and safety profile in routine clinical practice.1,2,3,4 Analysis from the CLEAR Outcomes trial underscores the impact of bempedoic acid on cardiovascular risks, including stroke and venous thromboembolism (VTE).5,6 Daiichi Sankyo Europe’s commitment to "care for every heartbeat" is centred on providing accessible oral treatment options to ensure every patient is given a chance to reach their LDL-C goals. Daiichi Sankyo Europe (DSE) is pleased to announce its extensive scientific presence at the European Atherosclerosis Society (EAS) Congress 2026. The presentation of 15 abstracts, comprising both clinical trial analyses and real-world evidence, underscores the company's sustained investment

OpenRouter Raises $113 Million CapitalG-led Series B as Weekly Volume Explodes to 25T Tokens26.5.2026 15:15:00 CEST | Press release

NVentures, ServiceNow Ventures, MongoDB Ventures, Snowflake Ventures, Databricks Ventures join CapitalG, a16z, Menlo Ventures, and others in backing the high-growth AI infrastructure startup OpenRouter, the AI model exchange, today announced a $113 million Series B led by Alphabet’s independent growth fund, CapitalG, with participation from investors including NVentures (NVIDIA’s venture capital arm), ServiceNow Ventures, MongoDB Ventures, Snowflake Ventures, Databricks Ventures, alongside existing investors including Andreessen Horowitz and Menlo Ventures. OpenRouter’s volume has surged to 25 trillion tokens per week (100 trillion tokens per month), representing a 5X increase from the 5 trillion tokens processed per week just six months ago. The explosion in token demand illustrates how quickly enterprises are deploying agents and scaling AI across multiple models and providers. OpenRouter’s infrastructure manages and optimizes inference and provides access to 400+ models across leadi

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye