MADRID – (PRNewswire) – Johnson & Johnson (NYSE: JNJ ) – August 31, 2025 – 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 .
1 Møller J, et al.Long Term Outcomes of the DanGer Shock Trial. N Engl J Med 2025
2Møller, 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