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

L&T Technology Services and Emerson Announce a Global Cooperation and Strategic Engagement to Drive Innovation in Engineering Excellence12.5.2026 11:30:00 CEST | Press release

Partnership in its Sustainability segment brings together LTTS’ engineering capabilities and Emerson’s NI test platform to accelerate system integration and product development across multiple industries L&T Technology Services (BSE: 540115, NSE: LTTS), a global leader in AI, Digital and Engineering R&D services, today announced a strategic global partnership with Emerson (NYSE: EMR), a global automation leader and provider of advanced test and measurement solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511346343/en/ L&T Technology Services and Emerson announce strategic global partnership. Seen in the picture: Senior leaders and delegates from L&T Technology Services and Emerson’s Test & Measurement business, including the NI leadership team. Under this engagement, LTTS will serve as a global System Integrator and technology development partner, supporting the design, deployment and lifecycle enablement of adva

Goldman Sachs Alternatives Acquires FGI Worldwide12.5.2026 11:00:00 CEST | Press release

Transaction Accelerates FGI’s Growth and Expands Product Offering FGI Worldwide LLC (“FGI” or the “Company”), a leading provider of working capital financing and trade credit insurance solutions, today announced it has been acquired by the Private Equity business within Goldman Sachs Alternatives. Over its 25-year history, FGI has established a strong reputation as a leader and innovator in asset-based lending and risk mitigation, specializing in multi-jurisdictional working capital solutions that support businesses with flexible financing to drive domestic and global expansion. The acquisition enables FGI to accelerate its growth and expand its suite of financing, risk and Insurtech solutions for clients. In conjunction with the transaction, Sami Altaher, Co-Founder and President of FGI, succeeds David DiPiero as Chief Executive Officer, marking the next chapter in the Company’s evolution. “We are grateful to our team, customers, partners and investors who have made this milestone pos

Kept Alive by ECMO Until Heart Transplant: Sahara Romero's Story of Survival and Recovery, with ECMOlife by Eurosets12.5.2026 10:45:00 CEST | Press release

“Now, for the first time in years, I can live without constantly fearing something could go wrong.” That's how Sahara Romero told her story, presented at the EuroELSO Congress in Dublin (6-8 May), dedicated to lifesaving extracorporeal therapies. Hers is a remarkable journey back to life, where clinical expertise and advanced life-support technologies came together to radically change her fate. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511305446/en/ Antonio Petralia, CEO of Eurosets; Sahara Romero, patient; dr. Mario Andrés Mercado Díaz, Intensive care specialist at the Clínica Shaio in Bogotá; Estefanía Giraldo Bejarano, specialist ECMO nurse at the Clínica Shaio in Bogotá Sahara has lived with a serious heart condition since early adolescence. The first signs of heart failure appeared when she was eleven. “When I was doing simple activities, like gymnastics lessons, I got very tired and experienced pain in my chest

New Research From Infobip Finds Disconnected Data and Systems Prevent Brands From Automating Customer Journeys at Scale12.5.2026 10:39:00 CEST | Press release

Global AI-first cloud communications platform Infobip’s 2026 Customer Experience (CX) Maturity Report reveals a widening gap between communications infrastructure investment and CX performance. With ever-increasing customer expectations, achieving CX maturity is the goal for major global brands. This hinges on how well brands can build experiences on mobile channels. There is a fundamental difference between a simple fraud alert on SMS and a two-way WhatsApp chat that allows customers to act immediately. While 96% of brands automate customer interactions in some way, few are delivering a seamless experience. Only 58% of brands say their channels are fully in sync, and 60% have centralized storage of customer data. But looking closer, only 27% use an orchestration platform, and 50% of brands say their tools are fully API-ready. This means half of brands struggle with connecting tools and data and many don't use a unified platform to build truly seamless experiences. This fragmentation i

Rerouting Alone Could Cost Airlines $8 Billion This Summer, New i6 Group Data Shows12.5.2026 10:00:00 CEST | Press release

Operational data from nearly 300 airports reveals that structural fuel costs are cutting into peak-season profits. Plus, European airports increased fuel stock by 62%, ahead of further supply disruption. Airlines flying European long-haul routes are facing a fuel cost penalty that could exceed $8 billion between May and August 2026, according to a new operational data report released today by i6 Group, a global leader in integrated aviation fuel management technology. The report, “Middle East Conflict: Summer 2026 Outlook,” draws on real fueling transactions captured at nearly 300 airports worldwide by i6's Fusion6 platform and provides insight into the costs of the conflict so far and how it might impact summer travel, based on actual fuel supply and into-plane uplift data. Key Findings $5.6 billion – $8.4 billion: Projected industry-wide rerouting fuel cost, May–August 2026 62.2%: Increase in European airport fuel book stocks (April 2026 vs. April 2025) 415,373 tons: Additional CO2 g

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