Abiomed Europe GmbH (Teil von Johnson & Johnson MedTech)

About Abiomed

Abiomed is a medical technology company founded in 1981, headquartered in Danvers (Massachusetts, USA), and has been part of Johnson & Johnson since December 2022. The company develops and manufactures temporary mechanical circulatory support systems, in particular the Impella heart pumps – microaxial pumps that are inserted into the heart via minimally invasive procedures and, at up to 50,000 rpm, unload the heart so it can recover. Other product lines include the Breethe OXY-1 ECMO system and catheter systems for treating acute heart failure. The European headquarters with R&D and production is located in Aachen, where around 520 employees work; an R&D site of ECP Entwicklungsgesellschaft mbH exists in Berlin. The Impella systems are used in cath labs and cardiac surgery worldwide; more than 450,000 patients have been treated to date, and the efficacy is documented in more than 1,500 peer-reviewed clinical studies.

Site

Aachen

Processes

Worldwide technical support (Impella Connect 24/7 cloud monitoring), Comprehensive training programs for physicians and medical staff, Consulting/practice support for therapies (Protected PCI, cardiogenic shock)

Materials

Impella heart pumps (microaxial pumps), Breethe OXY-1 System (ECMO), Impella Connect

Certificates

FDA approvals

Founded

1981

Employees

approx. 2000 worldwi

Industries

Medical technology, Cardiology/cardiac surgery, Cath labs, Intensive care medicine

1. 01

   Research & Development

2. 02

   Product Development/Engineering

3. 03

   Manufacturing

4. 04

   Regulatory Approval & Quality Control

5. 05

   Sales & Clinical Support

6. 06

   24/7 technical support (Impella Connect)

Technologies & Processes

Locations

Aachen

DE

European headquarters R&D/production (Abiomed Europe GmbH)

Berlin

DE

R&D (ECP Entwicklungsgesellschaft mbH)

Danvers

US

Head office, innovation center (2018)

Zug

CH

Branch office R&D/production/sales (Abiomed Aachen GmbH, since 2017)

Tokyo

JP

Subsidiary

Woburn

US

Location

Baltimore/Halethorpe

US

Location (Breethe)

Products

Inside the production

Quality & Regulatory Affairs

Abiomed is subject to FDA regulatory oversight; by 2022, five FDA approvals had been obtained, and the products are backed by approvals and clinical evidence (including the DanGer Shock RCT, New England Journal of Medicine). Since the acquisition by Johnson & Johnson, their quality and regulatory framework applies.

History

1. 1981

   Founded as Applied Biomedical Corporation by David M. Lederman in Danvers, Massachusetts

2. 2001

   AbioCor: first artificial heart successfully implanted

3. 2004

   Michael R. Minogue becomes President & CEO

4. 2005

   Acquisition of Impella CardioSystems AG (Aachen), establishment of the European headquarters, strategic focus shifts to Heart Recovery

5. 2006

   FDA approval of the AbioCor artificial heart

6. 2014

   Acquisition of ECP Entwicklungsgesellschaft mbH (Berlin) and AIS GmbH (Aachen)

7. 2018

   Opening of the $17 million innovation center in Danvers; inclusion in the S&P 500

8. 2020

   Acquisition of Breethe (Breethe OXY-1 ECMO system); FDA 510(k) clearance

9. 2021

   Acquisition of preCARDIA (catheter system for acute heart failure)

10. 2022

    Inauguration of the expanded Aachen headquarters (250 new high-tech jobs, approx. 520 employees); acquisition by Johnson & Johnson for 16.6 billion USD (completed 22.12.2022)

11. 2024

    DanGer Shock RCT published in the New England Journal of Medicine; survival benefit of Impella CP confirmed over a 10-year follow-up

12. 2025

    Abiomed/Impella brand presence is aligned with Johnson & Johnson MedTech