Randomized controlled trial confirms Impella CP improves survival in heart attack with cardiogenic shock

DANVERS, Mass., April 8, 2024 – A late breaking clinical trial, presented at the American College of Cardiology conference and simultaneously published in the New England Journal of Medicine, confirms routine use of Impella CP in patients who have had a heart attack with STEMI cardiogenic shock reduces 180-day mortality by 12.7%, compared to the control arm (45.8% vs. 58.5%, p=0.04).

The Danish German Cardiogenic Shock Trial (DanGer Shock) randomized controlled trial (RCT) is the first mechanical circulatory support device RCT to demonstrate a survival benefit in AMI cardiogenic shock patients.  The trial enrolled 360 participants at 14 sites in Denmark, Germany and the United Kingdom between 2013-2023 ^[1].

“We congratulate Dr. Møller and the independent group of investigators who initiated and completed this landmark trial,” said Chuck Simonton, MD, EVP and chief medical officer, Abiomed. “What impresses me most is that the significant survival benefit with Impella, compared to the control arm, improves over time.”

Approximately 750,000 people in the United States experience a ST-elevation myocardial infarction (STEMI), an acute heart attack, each year² and the overall incidence rate of cardiogenic shock in patients with STEMI is up to 10%³. Cardiogenic shock (CS) is the leading cause of in-hospital mortality in patients with ST-segment elevation myocardial infarction (STEMI) ⁴.

The authors state that the increased risk of adverse events does not overshadow the benefit of treatment with Impella CP, a microaxial flow pump. 

About Abiomed
Based in Danvers, Massachusetts, USA, Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical technology that provides circulatory support and oxygenation. Our products are designed to enable the heart to rest and recover by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure. For additional information, please visit www.abiomed.com.

About Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized. For more, visit https://thenext.jnjmedtech.com.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding Impella CP and Impella CP with SmartAssist. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Abiomed, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Abiomed, Inc.., nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

1 Moller, et al., New England Journal of Medicine, 7 Apr 2024

2 Abe, et al., Journal of the American Heart Association, 27 Feb 2023.
3 Kolte, et al., Journal of the American Heart Association, 13 Jan 2014

4 Cosentino, et al., Journal of Clinical Medicine, 21, May, 2021