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
AB InBev Reports Full Year and Fourth Quarter 2025 Results12.2.2026 07:01:00 CET | Press release
Underlying EPS increased by 6% with continued margin expansion and free cash flow generation of 11.3 billion USD Anheuser-Busch InBev (Brussel:ABI) (BMV:ANB) (JSE:ANH) (NYSE:BUD): This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260211688662/en/ Figure 14. Terms and debt repayment schedule as of 31 December 2025 (billion USD) Regulated and inside information1 “Beer plays an important role in bringing people together and creating moments of celebration. In 2025, we executed our strategy, made disciplined capital allocation choices and delivered growth within our outlook for the year, even as we navigated a dynamic consumer environment. We exit 2025 with improved momentum and enter 2026 well positioned to engage consumers with our megabrands and an unparalleled lineup of mega platforms. Thank you to our colleagues for their ongoing commitment, hard work and passion for our business.” – Michel Doukeris, CEO, AB InBev Revenue 4Q +
Bardasz Forms Strategic Digital Alliance with GEOLOG to Accelerate Global RTOC Delivery and Digital Well Construction Solutions12.2.2026 07:00:00 CET | Press release
HighlightsBardasz and GEOLOG form an alliance to strengthen delivery of end-to-end RTOC solutions for drilling optimization and NPT mitigation.Alliance combines Bardasz’s leadership in WITSML and ETP transmission, high-speed real-time data aggregation, and Super Store technology with GEOLOG’s global operational scale and local technical workforce.As part of the alliance, GEOLOG has made a minority investment in Bardasz, providing financial flexibility to accelerate Bardasz’s product roadmap and global expansion. Bardasz Group LLC (“Bardasz”), a provider of real-time, decision-ready intelligence for well construction—including drilling, completions, and well interventions—today announced a strategic digital alliance with GEOLOG International B.V. (“GEOLOG”), a global formation evaluation, drilling, and geochemistry services provider supporting subsurface projects in more than 40 countries. The alliance is designed to accelerate Bardasz’s global growth and enhance customer delivery by le
We Are All Sculptra: First-of-its-Kind Galderma Initiative to Demonstrate How Everyone Can Benefit from Sculptra’s Regenerative Properties12.2.2026 07:00:00 CET | Press release
Galderma unveils We Are All Sculptra, a global campaign capturing the clinical performance of Sculptra® across nine diverse patient profiles and journeys, over two years1 Backed by over 25 years of clinical use, Sculptra continues to prove its versatility as a regenerative treatment that works across all three layers of the skin2-6 The campaign captures the patients’ clinical and emotional experiences – including before & after treatment imagery – highlighting Sculptra’s adaptability and reinforcing its role in tailored, science-backed regenerative aesthetic care1 Galderma (SIX: GALD), the pure-play dermatology category leader, today unveiled We Are All Sculptra, a unique program designed to capture the clinical impact of Sculptra® across nine diverse patients – who were all new to injectable aesthetics – over two years.1 This innovative initiative will offer a rare and authentic real-life perspective on the power of regenerative biostimulation to deliver personalized outcomes, and dem
Lenovo Group: Third Quarter Financial Results 2025/2612.2.2026 05:13:00 CET | Press release
Lenovo delivers exceptional quarter, marks era of accelerated AI-driven growth and profitability Lenovo GroupLimited (HKSE: 992) (ADR: LNVGY), together with its subsidiaries (‘the Group’), today reported results for the third quarter of fiscal year 2025/26, a quarter that delivered record revenues, accelerated profitability, and continued AI revenue expansion. During the quarter, overall group revenue reached an all-time fiscal quarter high of US$22.2 billion, up 18% year-on-year, with revenue from all business groups growing double-digit year-on-year. Excluding non-operating non-cash items and one-time gains and charges in Q3 FY24/25 and Q3 FY25/26, adjusted net income (profit attributable to equity holders – non-HKFRS)[1] increased by 36% year-on-year to US$589 million, with adjusted net income margin[1] expanding to 2.7%. The results demonstrate the Group’s ability to deliver on its promise of double-digit growth and sustained profitability, while proving its ability to manage throu
IFF Reports Fourth Quarter and Full Year 2025 Results11.2.2026 22:36:00 CET | Press release
Delivered solid top and bottom-line performance & advanced strategic priorities in 2025Launched sale process for the Food Ingredients segmentContinuing to drive financial performance in 2026 International Flavors & Fragrances Inc. (NYSE: IFF) reported financial results for the fourth quarter and full year ended December 31, 2025. Full year 2025 Consolidated Summary: Management Commentary “IFF delivered a solid 2025 performance, meeting the full-year financial commitments we set at the start of the year, despite a challenging operating environment,” said Erik Fyrwald, CEO of IFF. “It was also a year of continued strategic progress. We invested in R&D, commercial capabilities, and capacity expansion to better serve customers, advance our innovation pipeline, and support future profitable growth.” “We also took steps to optimize our portfolio. Through several divestitures and the recent launch of a sale process for our Food Ingredients segment, we sharpened our strategic focus and improve
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