New Data from the DanGer Shock Randomized Control Trial, Published in The New England Journal of Medicine, Confirms the Long-Term Survival Benefit of the Impella CP Heart Pump
MADRID, Aug. 31, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) – Late breaking clinical science data, presented at the European Society of Cardiology (ESC) Congress today and simultaneously published in the New England Journal of Medicine (NEJM), finds at up to 10 years, when compared to standard care, routine use of Impella CP® in patients who have had a heart attack with cardiogenic shock leads to an absolute mortality reduction of 16.3% (95% CI: 0.54 to 0.92)1. When compared to the control arm at 10 years, Impella CP patients gained an average of 600 additional days alive (95% CI: 235 – 966 days)1.
These new findings from the long-term follow up of patients in the investigator-initiated DanGer Shock randomized controlled trial (RCT) were presented at ESC by the trial's principal investigator, Jacob Møller, MD.
"The long-term data from the DanGer Shock RCT released today validates the original findings and confirms that the survival benefit of Impella CP is durable and increases year-over-year," said Navin Kapur, MD, chief medical and scientific officer for heart recovery, J&J MedTech.
The absolute mortality reduction of 16.3% at up to 10 years is an increase from the initial 6-month data, which found routine use of Impella CP reduced the absolute risk of mortality by 12.7%2. Impella CP is the first mechanical circulatory support (MCS) proven in an RCT to provide short-term and long-term survival benefits in patients with cardiogenic shock due to STEMI. The American College of Cardiology (ACC) and American Heart Association (AHA) upgraded Impella to a class 2a guideline based on the original DanGer Shock RCT data presented at ACC in May 2024. The trial enrolled 360 participants at 14 sites in Denmark, Germany and the United Kingdom between 2013-20232.
Approximately 750,000 people in the United States experience an 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 STEMI4.
Impella, the world's smallest heart pump, is inserted into the heart to temporarily take over the heart's pumping function, allowing the heart to rest and recover while maintaining the flow of oxygenated blood throughout the body. This therapy allows patients to return to their life and families with their native heart and experience an equal – or improved – quality of life.
About Cardiovascular Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit www.heartrecovery.com and follow us on LinkedIn and @jjmt_heartrecov.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in cardiovascular, orthopedics, surgery and vision solutions at https://thenext.jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to the Impella Platform. 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 Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities related to the collaboration may not be realized or may take longer to realize than expected; challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; 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 most recent Annual Report on Form 10-K, 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, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
1 Møller J, et al. Long Term Outcomes of the DanGer Shock Trial. N Engl J Med 2025
2 Møller, J., et al. (2024). Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. N Engl J Med 2024; 390:1382-1393.
3 Kolte, et al., Journal of the American Heart Association, 13 Jan 2014
4 Cosentino, et al., Journal of Clinical Medicine, 21, May 2021
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