Press release
New Data at TCT 2024 Expands on Recently Published New England Journal of Medicine Randomized Controlled Trial Demonstrating a Survival Benefit from Impella Heart Pumps
Also at TCT: Impella ECP Pivotal Study Presentation
DANVERS, Mass. – October 24, 2024 – Novel data on the benefits of Impella® heart pump technology in high-risk percutaneous coronary intervention (PCI) and cardiogenic shock will be presented during the Transcatheter Cardiovascular Therapeutics (TCT) 2024 conference on October 27 – 30 in Washington, DC. During the four-day conference, leading physician researchers will share the latest evidence demonstrating the safety and survival benefits of Abiomed’s Impella heart pump technology. Abiomed, part of Johnson & Johnson MedTech and the global leader in heart recovery, will also showcase an updated innovation pipeline focused on smaller access expandable heart pump technology.
New Randomized Controlled Trial (RCT) Data on Reducing Adverse Events in Patients with ST-Elevation Myocardial Infarction (STEMI) and Cardiogenic Shock
On Sunday, October 27, during the TCT WorldLink Forum, results from multiple sub-analyses of the New England Journal of Medicine (NEJM)-published randomized controlled trial, known as DanGer Shock, will be presented. The results demonstrate the routine use of Impella CP in patients with STEMI and cardiogenic shock reduced all-cause 180-day mortality by an absolute 12.7% versus standard care. The new evidence will help physicians better understand and reduce adverse events in these patients. The sub-analyses include:
- Impact of Microaxial Flow Pump on Central Hemodynamics and Use of Vasoactive Drugs During Intensive Care After Infarct-Related Cardiogenic Shock: A Secondary Analysis of the DanGer Shock Trial (Nana Louise Junker Udesen, MD, PhD, Odense University Hospital, Denmark)
- Microaxial Flow Pump Use and Renal Outcomes in Cardiogenic Shock: An Analysis of the DanGer Shock Trial (Jacob Møller, MD, PhD, DMSc, Copenhagen University Hospital Rigshospitalet, Denmark)
- Impact of Bleeding Complications on Clinical Outcomes in Patients Undergoing Impella Support in Cardiogenic Shock (Lene Holmvang, MD, DMSc, Copenhagen University Hospital Rigshospitalet, Denmark)
Impella ECP Pivotal Clinical Trial Results
Abiomed will release results from the first completed pivotal investigational device exemption (IDE) trial on high-risk PCI patients supported with Impella ECP, a novel transvalvular axial flow pump with compressible pump architecture. With a 9Fr size at insertion, operators can implant and remove using small bore access and closure techniques.
The pivotal study, led by Amir Kaki, MD, director of mechanical circulatory support at Ascension St. John Hospital, enrolled 256 patients at 18 sites across the U.S. Dr. Kaki will give his presentation, “Mechanical Circulatory Support of High-Risk PCI with a Novel, Low-Profile pMCS: First Results of the Impella ECP Pivotal Study,” on Sunday, October 27 during the TCT World Innovation Forum.
Results from the Impella ECP pivotal study to be presented at TCT 2024.
Lunch Symposium
On Monday, October 28, Abiomed will host a lunch symposium with leading physician researchers about improving survival and reducing complications in acute myocardial infarction cardiogenic shock (AMICS) due to STEMI. Presenters include Navin Kapur, MD (Tufts Medical Center), Jacob E. Møller, MD, PhD, DMSc (Odense University Hospital), Rhian Davies, DO, MS (Wellspan York Hospital) and Mir Babar Basir, DO (Henry Ford Hospital). It will take place between 12:15-1:30 pm EDT in the FDA Theater (Innovation & Exhibit Hall).
Moderated Abstracts
The benefits of Impella heart pump technology in high-risk PCI and AMICS patients will be shared via moderated abstracts during TCT. Highlights include:
- Contemporary real-world studies from the Premier Healthcare Database analyzing the epidemiology of HRPCI patients supported by Impella or IABP (2018-2024) (TCT abstract #573; Tayyab Shah, MD) and comparative outcomes and cost analyses (TCT abstract #575; Tayyab Shah, MD).
- First look into TRUVETA, a national database aggregating patient level data across 31 healthcare systems in the U.S., comparing patients undergoing HRPCI supported by Impella or IABP (2015-2023) (TCT abstract #581; Amin Polzin, MD).
- Results from PROTECT III sub-studies of patients with and without chronic total occlusion (CTO) (TCT abstract #407; Batla Falah, MD) and with and without severe calcification (TCT abstract #576; Batla Falah, MD) undergoing Impella-supported HRPCI.
- Do Females Have Less Effect of Microaxial Flow Pump in Infarct Related Cardiogenic Shock: A Secondary Analysis of the DanGer Shock Trial (TCT abstract 791; Norman Mangner, MD).
Learning Opportunities for Healthcare Professionals
The Abiomed booth (#2403) featuring its heart recovery solutions will have opportunities for customers to learn more about recent product innovation, including Impella RP Flex, Impella Low Profile Sheath and best practices for improving patient outcomes with Impella devices. There will be an Impella simulation zone and virtual reality for customers to have hands-on experience with Impella heart pumps.
On Tuesday, October 29, hands-on training sessions will be held for fellows/early career physicians (2-3 pm EDT) and advanced providers (3:30-4:30 pm EDT) based on the evidence from the NEJM-published RCT. The DanGer Deep Dive sessions will focus on optimizing patient outcomes in AMICS, including access and ultrasound best practices and managing complications. These training courses will be led by leading physicians including Ralf Westenfeld, MD, Jason Wollmuth, MD, and Stephen Kidd, MD. In addition, Drs. Wollmuth and Kidd will lead a session focused on right heart failure and Impella RP Flex technology (5-6 pm EDT).
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 information about heart recovery technology, visit www.heartrecovery.com.
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 @JNJMedTech and on LinkedIn. Abiomed, Inc. is a Johnson & Johnson MedTech company.
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 Annual Report on Form 10-K for the fiscal year ended December 31, 2023, 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 does not undertake to update any forward-looking statement as a result of new information or future events or developments.
Contact:
Jenny Leary, [email protected]