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
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.
Johnson & Johnson (NYSE:JNJ) ha pubblicato dati a lungo termine rivoluzionari dello studio randomizzato DanGer Shock sull'Impella CP, pubblicati sul The New England Journal of Medicine e presentati al Congresso della European Society of Cardiology.
Lo studio ha mostrato che l'Impella CP ha ottenuto una riduzione assoluta della mortalit脿 del 16,3% a 10 anni rispetto alle cure standard, con un guadagno medio di vita di 600 giorni per paziente. Questo risultato migliora i dati iniziali a 6 mesi, che indicavano una riduzione della mortalit脿 del 12,7%.
Il trial, che ha arruolato 360 partecipanti in 14 centri tra Danimarca, Germania e Regno Unito, ha portato l'American College of Cardiology e l'American Heart Association ad aggiornare l'Impella a una raccomandazione di classe 2a. L'Impella CP risulta cos矛 il primo dispositivo di supporto circolatorio meccanico a dimostrare benefici di sopravvivenza sia a breve sia a lungo termine nei pazienti con shock cardiogeno correlato a STEMI.
Johnson & Johnson (NYSE:JNJ) anunci贸 datos a largo plazo innovadores del ensayo aleatorizado DanGer Shock sobre su bomba card铆aca Impella CP, publicados en The New England Journal of Medicine y presentados en el Congreso de la European Society of Cardiology.
El estudio mostr贸 que Impella CP consigui贸 una reducci贸n absoluta de la mortalidad del 16,3% a 10 a帽os frente a la atenci贸n est谩ndar, con una ganancia media de vida de 600 d铆as adicionales por paciente. Esta mejora supera los datos iniciales a 6 meses, que mostraban una reducci贸n de la mortalidad del 12,7%.
El ensayo, que incluy贸 a 360 participantes en 14 centros de Dinamarca, Alemania y Reino Unido, llev贸 al American College of Cardiology y a la American Heart Association a elevar la recomendaci贸n para Impella a clase 2a. As铆, Impella CP se convierte en el primer dispositivo de soporte circulatorio mec谩nico que demuestra beneficios de supervivencia tanto a corto como a largo plazo en pacientes con shock cardiog茅nico relacionado con STEMI.
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鞐瓣惮 瓴瓣臣 鞛勴帬霛� CP電� 響滌 旃橂鞕� 牍勱祼頃� 10雲� 雸勳爜 旮办鞙茧 鞝堧寑 靷毳犾潉 16.3% 臧愳唽鞁滌及瓿�, 頇橃瀽雼� 韽夑窢 600鞚检潣 於旉皜 靸濎〈鞚� 鞝滉车頃� 瓴冹溂搿� 雮橅儉雮姷雼堧嫟. 鞚措姅 6臧滌洈 鞁滌爯鞚� 12.7% 靷毳� 臧愳唽 瓴瓣臣氤措嫟 臧滌劆霅� 靾橃箻鞛呺媹雼�.
雿措韥�, 霃呾澕, 鞓侁淡鞚� 14臧� 旮瓣磤鞐愳劀 360氇�鞚� 霌彪霅� 鞚� 鞁滍棙 瓴瓣臣電� American College of Cardiology鞕� American Heart Association鞚� 鞛勴帬霛检棎 雽�頃� 甓岅碃 霌标笁鞚� 2a旮�鞙茧 靸來枼臁办爼頃橂姅 瓿勱赴臧� 霅橃棃鞀惦媹雼�. 鞛勴帬霛� CP電� STEMI 甏�霠� 鞁澑靹� 靽柬伂 頇橃瀽鞐愳劀 雼赴肟� 鞎勲媹霛� 鞛リ赴 靸濎〈 鞚挫爯鞚� 鞛呾霅� 觳� 旮瓣硠鞝� 靾滍櫂氤挫“ 鞛レ箻鞛呺媹雼�.
Johnson & Johnson (NYSE:JNJ) a annonc茅 des donn茅es 脿 long terme r茅volutionnaires issues de l'essai randomis茅 DanGer Shock concernant sa pompe cardiaque Impella CP, publi茅es dans The New England Journal of Medicine et pr茅sent茅es au congr猫s de la European Society of Cardiology.
L'茅tude a montr茅 que l'Impella CP obtenait une r茅duction absolue de la mortalit茅 de 16,3% sur 10 ans par rapport aux soins standard, offrant en moyenne 600 jours de vie suppl茅mentaires par patient. Cette am茅lioration d茅passe les r茅sultats initiaux 脿 6 mois, qui montraient une r茅duction de mortalit茅 de 12,7%.
L'essai, qui a enr么l茅 360 participants dans 14 centres au Danemark, en Allemagne et au Royaume鈥慤ni, a conduit l'American College of Cardiology et l'American Heart Association 脿 relever la recommandation pour l'Impella au rang de classe 2a. L'Impella CP devient ainsi le premier dispositif d'assistance circulatoire m茅canique d茅montrant des b茅n茅fices de survie 脿 court et 脿 long terme chez les patients en choc cardiog茅nique li茅 脿 un STEMI.
Johnson & Johnson (NYSE:JNJ) hat bahnbrechende Langzeitdaten aus der randomisierten DanGer Shock-Studie zu ihrer Impella CP-Herzpumpe ver枚ffentlicht; die Ergebnisse wurden im The New England Journal of Medicine publiziert und auf dem Kongress der European Society of Cardiology vorgestellt.
Die Studie zeigte, dass die Impella CP im Vergleich zur Standardbehandlung 眉ber 10 Jahre eine absolute Mortalit盲tsreduktion von 16,3% erzielte und den Patienten im Schnitt 600 zus盲tzliche Lebenstage verschaffte. Diese Verbesserung 眉bertrifft die initialen 6鈥慚onats鈥慏aten, die eine 12,7%ige Mortalit盲tsreduktion zeigten.
Die Studie rekrutierte 360 Teilnehmer an 14 Zentren in D盲nemark, Deutschland und Gro脽britannien und f眉hrte dazu, dass das American College of Cardiology und die American Heart Association die Empfehlung f眉r Impella auf Klasse 2a anheben. Damit ist die Impella CP das erste mechanische Kreislaufunterst眉tzungsger盲t, das sowohl kurz鈥� als auch langfristige 脺berlebensvorteile bei Patienten mit STEMI鈥慳ssoziiertem kardiogenem Schock belegt.
- 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
- None.
Insights
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.
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 M酶ller, 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
Approximately 750,000 people in
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 鈥� or improved 鈥� quality of life.
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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 , , 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 M酶ller J, et al.听 Long Term Outcomes of the DanGer Shock Trial. N Engl J Med 2025
2 M酶ller, J., et al. (2024). Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. N Engl J Med 2024; 390:1382-1393.
3听Kolte, et al., Journal of the American Heart Association, 13 Jan 2014
4听Cosentino, et al., Journal of Clinical Medicine, 21, May 2021
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