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

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.

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 (2-3pm EDT) and advanced providers (3:30-4:30pm 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 (5-6pm EDT).