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
Prudentia Sciences Announces Series A Led by McKesson Ventures, Accelerating Due Diligence for Life Sciences Dealmaking7.1.2026 15:00:00 EET | Press release
Prudentia Sciences, a pioneer in AI-native due diligence for life sciences dealmaking, today announced that it has secured $20 million in Series A financing. The round was led by McKesson Ventures with participation from SignalFire. Existing investors include Iaso Ventures, Virtue and GV. This brings the company’s total funding to $27 million, following a $7 million seed round in 2024. Prudentia Sciences provides an AI-native platform that enables pharma companies, biotechs, and financial institutions to evaluate breakthrough medicines with unprecedented speed and rigor. By synthesizing complex clinical signals into actionable insights, Prudentia accelerates deal throughput and provides strategic leverage for acquisition, licensing, or investment decisions made by business development, investment, and diligence teams. The company’s human-in-the-loop approach orchestrates seamless collaboration between buyers, sellers, and intermediaries. This ensures a secure, compliant infrastructure
Compass Pathways Announces FDA Acceptance of IND Application for PTSD and Hosts Webinar on PTSD and TRD7.1.2026 13:30:00 EET | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for COMP360, enabling the initiation of a late-stage clinical trial in patients with PTSD. Compass management, along with KOL and industry leaders, will host a webinar today to discuss the company’s clinical trial plans for PTSD, as well as commercial preparations for treatment-resistant depression (TRD) from 10:00-11:30 am ET on January 7th. “PTSD is one of the most challenging mental health conditions, with approximately 13 million adults in the U.S. living with persistent symptoms and limited treatment options,” said Dr. Guy Goodwin, Chief Medical Officer at Compass Pathways. “We are pleased to advance our clinical development - the unmet need is profound, and it demands bold innovation. We believe COMP360 has the potential to tra
Stallergenes Greer Expands Venom Immunotherapy Production Capacity With Acquisition of Entomon s.r.l.7.1.2026 12:07:00 EET | Press release
Stallergenes Greer, a global leader in allergy therapeutics, today announced that it has entered into an agreement to acquire Entomon s.r.l., an Italian company specialising in the production of certified stinging-insect venom extracts, notably of the Hymenoptera order, used for the manufacture of diagnostic preparations and Venom Immunotherapy (VIT). The transaction is expected to close by the end of January. Entomon, currently recognised as the only company in Europe capable of extracting pure venom from Hymenoptera insects, produces pharmaceutical-grade insect venom using proprietary techniques (Entomon Capillary Extracted Venom®) for medical use. Through this acquisition, Stallergenes Greer bolsters its venom manufacturing capabilities and supply of raw materials for life-saving VIT treatments, whilst safeguarding patient care continuity. Hymenoptera venom allergy is the most common trigger of severe anaphylaxis in adults1. According to the EAACI guidelines on venom immunotherapy,
ARIS Announces New CEO to Lead Agentic AI-led Strategy7.1.2026 11:00:00 EET | Press release
CEO Appointment ARIS, a global leader in process intelligence and transformation software, today announced the appointment of Guillaume Bacuvier as Chief Executive Officer. Guillaume will lead ARIS through its next phase of growth as a fully standalone company, accelerating its evolution from a market leader in Process Intelligence into a foundational platform for enterprises deploying and governing Agentic AI. Guillaume brings deep international leadership experience across technology, data, and software-enabled businesses, with a proven track record of scaling global platforms and leading complex organisations. After starting as a strategic consultant at Booz Allen Hamilton, Guillaume spent over a decade at Google, rising to Vice President in EMEA where he built and scaled some of Google’s largest data-driven businesses in Europe and held P&L responsibility across multiple countries. In the last decade, Guillaume has served as CEO of multi-continent, data-centric companies including
I Squared Capital Acquires Ramudden Global, a Leader in Traffic Management and Infrastructure Safety7.1.2026 10:00:00 EET | Press release
I Squared Capital, a leading global infrastructure investment manager, today announced that, through its flagship fund, it has agreed to acquire Ramudden Global, from funds advised by Triton Partners (“Triton”), a leading European mid-market sector-specialist investor. Ramudden Global is a leading international provider of traffic management and infrastructure safety services supporting the maintenance and upgrade of essential transport and utility networks. The company operates more than 190 depots across 13 countries in Europe and North America delivering mission-critical services that help to ensure safety, regulatory compliance and continuity of service across road, utility and broader infrastructure works. This investment underscores I Squared Capital’s commitment to investing in essential, regulated, infrastructure businesses that underpin public safety, mobility and economic activity. Ramudden operates in markets where demand is steady and growing and benefits from deep commerci
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