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

Rhea-AI Summary

Johnson & Johnson (NYSE:JNJ) announced groundbreaking long-term data from the DanGer Shock randomized controlled trial for its Impella CP heart pump, published in The New England Journal of Medicine and presented at the European Society of Cardiology Congress.

The study demonstrated that Impella CP achieved an absolute mortality reduction of 16.3% over 10 years compared to standard care, with patients gaining an average of 600 additional days of life. This improvement surpasses the initial 6-month data, which showed a 12.7% reduction in mortality.

The trial, which enrolled 360 participants across 14 sites in Denmark, Germany, and the UK, led to the American College of Cardiology and American Heart Association upgrading Impella to a class 2a guideline recommendation. This marks Impella CP as the first mechanical circulatory support device proven to provide both short-term and long-term survival benefits in STEMI-related cardiogenic shock patients.

Positive

• Significant absolute mortality reduction of 16.3% over 10 years
• Patients gained an average of 600 additional days alive compared to control group
• First mechanical circulatory support device proven effective in both short and long-term survival
• Upgraded to class 2a guideline by ACC/AHA based on trial results

Negative

• None.

Insights

Medical Device Clinical Trial Expert

DanGer Shock trial shows Impella CP heart pump delivers durable, increasing survival benefits with 16.3% mortality reduction over 10 years.

The long-term follow-up data from the DanGer Shock randomized controlled trial demonstrates remarkable durability of survival benefits for the Impella CP heart pump in patients suffering heart attacks with cardiogenic shock. The trial showed an absolute mortality reduction of 16.3% compared to standard care, with patients gaining an average of 600 additional days alive over the 10-year follow-up period.

What's particularly significant is the increasing benefit over time - the absolute mortality reduction grew from 12.7% at 6 months to 16.3% at 10 years, indicating that the survival advantage continues to accumulate rather than diminishing. This represents a paradigm shift in mechanical circulatory support (MCS) evidence, as Impella CP becomes the first MCS device with proven short and long-term survival benefits in this patient population.

The study's robust design enhances its credibility - a multi-center RCT with 360 participants across 14 sites in three European countries. This level of evidence has already triggered the American College of Cardiology and American Heart Association to upgrade Impella to a class 2a guideline recommendation, which will likely accelerate clinical adoption.

For context, cardiogenic shock complicates up to 10% of the 750,000 annual STEMI cases in the US and remains the leading cause of in-hospital mortality in these patients. The Impella device, by temporarily taking over heart pumping function, appears to create conditions that allow for meaningful cardiac recovery - enabling patients to return to normal life with their native heart intact, avoiding transplantation or permanent support devices.

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.

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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

Media Contacts:

Tom Langford
tlangfor@its.jnj.com

Erin Farley
Efarley1@its.jnj.com

Investor Contact:
Sandra Easton
investor-relations@its.jnj.com 

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SOURCE Johnson & Johnson MedTech

FAQ

What are the key findings of JNJ's DanGer Shock trial for Impella CP?

The trial showed that Impella CP achieved a 16.3% absolute mortality reduction over 10 years and patients gained an average of 600 additional days of life compared to standard care.

How many patients were enrolled in JNJ's DanGer Shock trial for Impella CP?

The trial enrolled 360 participants across 14 sites in Denmark, Germany, and the United Kingdom between 2013-2023.

What is the significance of Impella CP's new classification by ACC/AHA?

The American College of Cardiology and American Heart Association upgraded Impella to a class 2a guideline, making it the first mechanical circulatory support proven effective for both short and long-term survival benefits.

How does the Impella CP heart pump work?

Impella CP is the world's smallest heart pump that is inserted into the heart to temporarily take over pumping function, allowing the heart to rest and recover while maintaining oxygenated blood flow throughout the body.

What is the market potential for JNJ's Impella CP in the United States?

Approximately 750,000 people in the US experience STEMI annually, with up to 10% developing cardiogenic shock, which is the leading cause of in-hospital mortality in STEMI patients.