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
Steady concentration PD with the Carry Life UF system increased ultrafiltration nearly threefold and sodium removal nearly tenfold vs 2.5% dextrose CAPD, while improving glucose efficiency and supporting enhanced fluid management in PD patients4.6.2026 16:45:00 CEST | Press release
Triomed AB today announced positive results from a prospective, multicenter, randomized, crossover study evaluating steady concentration peritoneal dialysis using the Carry Life UF system in adult patients undergoing CAPD. The study demonstrated significant improvements in ultrafiltration, peritoneal sodium removal and glucose ultrafiltration efficiency (ultrafiltration volume in relation to glucose absorption) compared with standard 2.5% dextrose CAPD in the home setting over four weeks. The study results were presented as a Focussed Oral presentation based on a late-breaking clinical trial abstract at the European Renal Association (ERA) Congress in Glasgow, United Kingdom, and simultaneously published in the Journal of the American Society of Nephrology (JASN). In this study, participants received their standard CAPD treatment during the control arm, whereas in the Carry Life UF arm, one daily 2.5% dextrose exchange was replaced by a Carry Life UF treatment three days per week, and
The Empire State Building’s Tastes of New York Experience to Feature Eataly4.6.2026 16:44:00 CEST | Press release
Gelato, cannoli, and tiramisù available on the 86th Floor Observation Deck from June 4 through Aug. 31 The Empire State Building (ESB), the “World’s Most Famous Building,” today announced that it will feature Eataly as its latest Tastes of New York Experience, a year-round offering of pop-ups which feature unique New York City bites. From June 4 through Aug. 31, Eataly will bring its New York City spin on “la dolce vita” to the Empire State Building’s iconic Observation Deck with a curated selection of its most beloved desserts and beverages. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260604332533/en/ Gelato, cannoli, and tiramisù available on the 86th Floor Observation Deck from June 4 through Aug. 31 “We are excited to present Eataly’s true ‘estate Italiana’ as part of our year-round featured Tastes of New York to our visitors,” said Dan Rogoski, observatory general manager. “The Empire State Building can be seen and p
JCÖNTENTS “Zip to your destination, even with a language barrier.”4.6.2026 16:00:00 CEST | Press release
Converting a map into a QR code! Launching GOPin, the app that connects inbound tourists with taxis! So convenient, you’ll wonder why it never existed before! JCÖNTENTS releases free GOPin smartphone app on June 1! JCÖNTENTS Co., Ltd. (Kyoto Prefecture; Representative: Takamasa Yoshimitsu) released the free GOPin app for smartphones on June 1! GOPin is a completely new, multilingual navigation app that connects tourists visiting Japan with local taxi drivers through QR codes. All users have to do is select where they want to go on the map and show the QR code. The taxi driver will scan that to instantly display an accurate route in Google Maps. No more worries about entering addresses or pronunciation issues. GOPin doesn’t require any user registration and is free to use. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260601449250/en/ GOPin! For Visitors to Japan Say goodbye to the language barrier— just show your smartphone
Impartner Recognized as a Leader in G2 Summer 2026 Enterprise Grid® for Partner Relationship Management4.6.2026 15:00:00 CEST | Press release
Named a G2 Leader in both Partner Relationship Management and Through-Channel Marketing, reflecting strong customer satisfaction and enterprise momentum. Impartner, the world’s leading partner revenue orchestration platform, today announced it has been named a Leader in the G2 Summer 2026 Enterprise Grid® Report for Partner Relationship Management (PRM). The recognition underscores Impartner’s strong customer validation and continued momentum among enterprise organizations managing large-scale partner ecosystems and indirect sales channels. In the Summer 2026 report, Impartner earned Leader status based on strong customer satisfaction and adoption across organizations operating at scale. G2’s findings show a 4.5 out of 5-star rating from more than 500 verified reviews, with 91% of users indicating they would recommend the platform. Customers gave high marks for key capabilities, including Role-Based Permissions, Deal Management, and Content Repository, with Ease of Doing Business With
Fortegra Appoints Mark Rattner as President4.6.2026 15:00:00 CEST | Press release
The Fortegra Group, Inc. ("Fortegra" or the "Company"), a global specialty insurer and part of DB Insurance Co., Ltd., today announced the appointment of Mark Rattner as President. Mr. Rattner, who previously served as Executive Vice President and Chief Underwriting Officer, Insurance, brings a decade of Fortegra leadership and long-standing relationships with reliable distribution partners to his expanded role. Drawing on disciplined underwriting expertise built over a career spanning more than three decades, Mr. Rattner is focused on delivering the highest value and consistent results to the agents and brokers the company serves. His appointment reflects Fortegra’s continued investment in the people and partnerships that drive long-term, sustainable profitability. “Mark has been central to building Fortegra into the company it is today. His industry experience, knowledge, and trade craft make him the right person for this role. As we continue to evolve, Mark will enhance our partners
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