New long-term data from the DanGer Shock randomized controlled trial, presented at the European Society of Cardiology Congress and published in The New England Journal of Medicine, show that routine use of the Impella CP heart pump in patients who have suffered a heart attack with cardiogenic shock results in a 16.3% absolute reduction in mortality over up to 10 years compared to standard care. Patients treated with Impella CP also gained an average of 600 additional days alive compared to those receiving standard treatment.
The DanGer Shock trial was led by principal investigator Jacob Møller, MD. The study followed 360 participants across sites in Denmark, Germany, and the United Kingdom between 2013 and 2023.
“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 at J&J MedTech.
The new findings expand on initial six-month results that showed a 12.7% absolute risk reduction in mortality with routine use of Impella CP. The device is now recognized as the first mechanical circulatory support proven through randomized controlled trials to offer both short- and long-term survival benefits for patients experiencing cardiogenic shock due to ST-elevation myocardial infarction (STEMI). Based on earlier trial data presented in May 2024, both the American College of Cardiology and American Heart Association upgraded their guidelines for Impella to class 2a.
Each year, about 750,000 people in the United States experience STEMI—an acute type of heart attack—and up to 10% develop cardiogenic shock as a complication. Cardiogenic shock remains the leading cause of death among hospitalized STEMI patients.
Impella is described as the world’s smallest heart pump. It is inserted into the heart to temporarily take over pumping functions so that oxygenated blood continues circulating while allowing cardiac tissue time to recover.
Johnson & Johnson MedTech’s cardiovascular portfolio includes technologies for mapping, navigation, ablation therapy, and miniaturized devices aimed at treating complex conditions such as heart failure and stroke. The company states it is committed to advancing care for two major causes of death worldwide: heart failure and stroke. More information can be found at www.heartrecovery.com or via their LinkedIn page or @jjmt_heartrecov social media account.
Johnson & Johnson describes its mission as building healthcare innovations across medicine and MedTech sectors covering cardiovascular disease management among other areas. Details about its global reach are available at https://thenext.jnjmedtech.com.
A cautionary note included with this announcement reminds readers that forward-looking statements involve risks including research challenges, regulatory uncertainties, competition from new products or patents by competitors, manufacturing delays or recalls due to efficacy concerns, changes in healthcare regulations or spending patterns, among others. Additional details on these risks are available through Johnson & Johnson’s filings with U.S. securities regulators.