Johnson & Johnson MedTech to Highlight Latest Advancements in Heart Disease Treatment with Impella at ACC.25

News provided by

Mar 27, 2025, 08:00 ET

Impella heart pump upgraded to Class 2a in ACC/AHA treatment guideline for cardiogenic shock secondary to STEMI

DANVERS, Mass., March 27, 2025 /PRNewswire/ -- Johnson & Johnson MedTech, the global leader in heart recovery, will feature the latest evidence demonstrating the survival benefit of Impella^® heart pump technology at the American College of Cardiology's 74th Annual Scientific Sessions & Expo (ACC.25), taking place in Chicago from March 29-31, 2025. Last month, the ACC and the American Heart Association (AHA) updated their guideline for the treatment of acute coronary syndrome (ACS), upgrading Impella from Class 2b to Class 2a due to Impella's proven ability to increase survival in patients with cardiogenic shock secondary to ST-segment elevation myocardial infarction (STEMI). The guideline update states it is reasonable to specifically use Impella in this patient population and that its survival benefit outweighs the risk. Several ACC sessions and presentations will focus on how providers are adapting to implement guideline-informed care based on the recommendations to enable better patient outcomes.

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.

ACC/AHA Updated Guideline

The guideline upgrade for Impella (Impella CP^®) is based on evidence from the DanGer Shock RCT, which was published in the New England Journal of Medicine¹ and presented at ACC.24. DanGer Shock is the first acute myocardial infarction cardiogenic shock (AMICS) trial to achieve its primary survival endpoint and showed a 26% overall relative risk reduction with a number needed to treat of 8 (p-0.04)² in patients treated with Impella compared to the control arm. Since the data was released last year, multiple DanGer Shock sub analyses have been published, providing important details about the data:

A Journal of the American College of Cardiology study demonstrates that patients under 77 years of age experience an even greater effect with an NNT of 5 (p=0.001).^³
A JAMA Cardiology study shows that Impella reversed shock-related lactic acidosis significantly faster than controls and reduces the dependency on vasoactive drugs.⁴

"The DanGer Shock RCT results provide the highest level of scientific evidence demonstrating that Impella CP increases survival in patients with cardiogenic shock secondary to STEMI, which led the ACC/AHA to update their acute coronary syndrome treatment guideline within a year of the data being released," says Chuck Simonton, MD, Executive Vice President and Chief Medical Officer, Heart Recovery, Johnson & Johnson MedTech. "We will continue working with healthcare professionals to ensure that they are equipped with the training and clinical support necessary to implement guideline-informed care in their institutions, which will allow more patients to achieve heart recovery."

Additional subanalyses show that adverse events in the DanGer Shock RCT are transient, including that bleeding was not associated with an impact on survival⁵ and no patients requiring temporary dialysis remained on dialysis at six months.⁶ Previous studies have demonstrated that STEMI-related cardiogenic shock patient outcomes can be further optimized with the use of Impella best practices, including a 2023 Japanese Percutaneous Ventricular Assist Device (J-PVAD) publication.⁷

Learning Opportunities for Healthcare Professionals

The Johnson & Johnson booth at ACC.25 (#11013) will feature opportunities for healthcare providers to learn more about the updated treatment guideline for STEMI and cardiogenic shock and training and educational resources will be available.

Additionally, there will be hands on case-based simulation sessions on best practices in Impella patient management moderated by leading healthcare provider experts in the Critical Care Sim Zone. There will also be a CME skills tent, "Lonely Nights in the ICU," which will be led by ACC faculty and will include a presentation on mechanical circulatory support.

Sessions of Interest

At ACC25, there will be live sessions, poster presentations and panel discussions focused on the latest advancements in treating heart disease patients with Impella, including cardiogenic shock and heart failure. Below are a few examples; click here to see a full list (with details on timing and locations):

A Little Less Conversation, A Little More Action: SCAI Staging System of Cardiogenic Shock - Roy S. Gardner, MD
All Shock Up: Diagnosing Cardiogenic Shock Profiles - Anju Bhardwaj, MD
Impella for All? Lessons Learned from DanGer Shock and More! - Marwan Jumean, MD
Putting it All Together: Cardiogenic Shock Management in 2025 - Shashank S. Sinha, MD
DanGer Shock: One Year Later What Have We Learned? - Jacob E. Møller, MD
Has DanGer Moved the Needle: Are More Trials Needed? - Judith S. Hochman, MD
Overview of Modern MCS (Durable and Temporary) - Joyce W. Wald, MD

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, orthopaedics, surgery and vision solutions at https://thenext.jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn. ABIOMED, Inc. is part of Johnson & Johnson MedTech.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the Impella Platform. 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 ABIOMED, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of healthcare products and services; and trends toward healthcare 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 sec.gov, jnj.com or on request from Johnson & Johnson. Neither ABIOMED, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

_____________________________

¹ Møller, J., et al. (2024). Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. N Engl J Med 2024;390:1382-1393.
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 Klein, A., et al. (2024). Treating Older Patients in Cardiogenic Shock With a Microaxial Flow Pump: Is it DANGERous? J Am Coll Cardiol. 2025 Feb 18;85(6).
⁴ Udesen, NLJ., et al. (2024). Microaxial Flow Pump Hemodynamic and Metabolic Effects in Infarct-Related Cardiogenic Shock: A Substudy of the DanGer Shock Randomized Clinical Trial. JAMA Cardiol. 2025;10(1):9-16.
⁵ Holmvang, Lene. Impact of Bleeding Complications on Clinical Outcomes in Patients Undergoing Impella Support in Cardiogenic Shock (abstract) in: Transcatheter Cardiovascular Therapeutics (TCT) Conference; 2024 October 27-30; Washington, DC.
⁶ Zweck, E., et al. Microaxial Flow Pump Use and Renal Outcomes in Infarct-Related Cardiogenic Shock: A Secondary Analysis of the DanGer Shock Trial. Circulation (2024). Volume 150, Number 25.
⁷ Ikeda, Y., et al. (2023). Short-Term Outcomes of Impella Support in Japanese Patients With Cardiogenic Shock Due to Acute Myocardial Infarction - Japanese Registry for Percutaneous Ventricular Assist Device (J-PVAD). Circulation journal: official journal of the Japanese Circulation Society, 87(5), 588–597.