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/
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.
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210304005331/en/
Contact information
Dr. Sebastian Heindrichs
Associate Director European Communications
Phone: +49 151 7447 2278
E-mail: sheindrichs@abiomed.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Almirall Presents Long‑Term Results from First Real‑World Dermatology Study Using WHO‑5 Well‑Being Index as Primary Endpoint in the treatment of Psoriasis at EADV 202518.9.2025 09:00:00 EEST | Press release
Almirall, S.A. (ALM) a global biopharmaceutical company focused on medical dermatology today announced new long-term results from the POSITIVE study, presented as a late-breaker at the 34th Congress of the European Academy of Dermatology and Venereology 2025 (EADV) in Paris. POSITIVE is the first RWE study in dermatology to use the World Health Organization Well-Being Index (WHO-5) as a primary endpoint. The selection of the abstract as a late breaker at the EADV congress highlights the importance of the findings of the POSITIVE study and its unique approach to evaluating the long-term holistic impact of an advanced treatment in patients with moderate-to-severe psoriasis, a condition that profoundly impairs social, psychological, and physical quality of life, impacting overall well-being1. Two‑Year Real‑World Results from POSITIVE The 24-month, multinational, phase IV observational study enrolled 785 adult patients with moderate-to-severe plaque psoriasis across nine European countries
Shield and PwC UK Forge Strategic Collaboration to Deliver Future-Ready Communications Compliance18.9.2025 09:00:00 EEST | Press release
Shield, a leading AI platform for digital communication governance and archiving, today announced a collaboration with PwC UK, one of the world’s most trusted professional services firms. The alliance brings together Shield’s unified, cloud-native solution with PwC’s specialist expertise in communications surveillance delivery, regulatory compliance and complex programme execution. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250917394739/en/ Shield and PwC launch a strategic collaboration to modernize eComms surveillance with AI-driven compliance solutions for financial institutions. The collaboration is designed to support institutions as they modernise their approach to communications monitoring, helping them implement an advanced and proactive risk management approach at scale and with confidence. This joint offering provides an end-to-end solution designed to meet evolving regulatory expectations, accelerate adoption
Curatis: FDA Minutes Confirm Positive Outcome of Meeting on 9. September 2025 – Corticorelin on Track for Phase 318.9.2025 08:00:00 EEST | Press release
Curatis Holding AG (SIX:CURN) received the official minutes from the FDA meeting which took place on 9. September. Based on the totality of the feedback and discussions, Curatis can proceed as planned with the clinical development of corticorelin. Corticorelin is under development as a novel treatment intended to reduce or even eliminate steroid use and associated toxicities thereby potentially impacting the quality of life of patients suffering from peritumoral brain edema (PTBE) associated with metastatic (secondary) brain tumors. The virtual meeting with the FDA provided the opportunity to discuss the clinical development plan for corticorelin and encompassed CMC (Chemistry, Manufacturing and Control), nonclinical and clinical aspects. The offical FDA minutes which Curatis received after publication of the half year results reflect the positive outcome. Curatis may proceed without delay to a regulatory submission supporting a pivotal study in patients suffering from PTBE secondary t
Merck Opens Climate-Neutral €150 Million Filter Manufacturing Facility in Ireland18.9.2025 08:00:00 EEST | Press release
Merck, a leading science and technology company, has opened today its €150 million filter manufacturing facility in Blarney Business Park, Cork, Ireland. The site is Merck’s first manufacturing facility designed for full climate-neutral operations, marking a key milestone in the company’s ambition to achieve climate neutrality by 2040. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250917767425/en/ Merck's new Blarney site in Cork expands company's filter capacity, creating 200+ jobs by 2028 The 3,000-square-meter cleanroom facility supports global demand for critical filtration products used in the manufacturing of vaccines and life-saving therapies, including monoclonal antibodies, and emerging modalities like cell and gene therapies. By localizing these capacities in Europe, Merck hopes to reduce cross-border dependencies for the company’s customers. “Ireland is a leading hub for biopharmaceutical manufacturing and innova
Galderma Launches Transformative Skincare Segment With Cetaphil’s New Skin Activator Hydrating & Firming Line, in Partnership With Actor and Filmmaker Mariska Hargitay18.9.2025 08:00:00 EEST | Press release
Galderma today announced Cetaphil, the dermatologist-recommended brand trusted by millions with sensitive skin, is redefining daily skincare with its new Skin Activator Hydrating & Firming line. The launch marks an entirely new skincare segment of advanced hydration and firming solutions designed specifically for improving the appearance of aging, thinning, and fragile skin. As people age, surface skin cells stop performing at the same level, or “go to sleep,” causing fine lines, dehydration, and looser skin, in turn leading to skin looking and feeling less firm and more fragile.1 Skin Activator technology serves as a “wake-up call” to sleeping surface skin cells. The unique complex is powered by encapsulated CICA to help restore the skin’s moisture barrier to visibly plump and firm skin as well as microdosed mandelic acid to increase surface skin cell turnover to visibly reduce dull, uneven skin. In clinical trials, the Skin Activator Hydrating & Firming Lotion showed to be effective
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