Unloading with Impella for 30 Minutes Before PCI Associated with Reduced Infarct Size in STEMI Patients
17.9.2022 16:02:00 EEST | Business Wire | Press release
Results of a new per-protocol analysis of the ST-segment Elevation Myocardial Infarction Door-To-Unload (STEMI DTU) pilot trial data show significantly reduced infarct size in patients who received left ventricular (LV) unloading with Impella CP for 30 minutes prior to their percutaneous coronary intervention (PCI) compared to patients who received LV unloading followed by immediate PCI. The data were presented today during the 2022 Transcatheter Cardiovascular Therapeutics (TCT) conference in Boston by Navin K. Kapur, MD, executive director of the Cardiovascular Center for Research and Innovation (CVCRI) at Tufts Medical Center and the principal investigator for the STEMI DTU pivotal randomized controlled trial.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220917005003/en/
The STEMI DTU pilot trial demonstrated for the first time that LV unloading using the Impella CP® heart pump with a 30-minute delay before reperfusion is safe and feasible. (Graphic: Business Wire)
The new analysis compared infarct size in 32 patients from the STEMI DTU pilot trial who met all inclusion and exclusion criteria. All patients experienced an anterior STEMI and completed one of two treatment protocols – LV unloading with Impella CP followed by immediate PCI (n=15) or LV unloading with Impella CP for 30 minutes prior to delayed PCI (n=17). Cardiac magnetic resonance (CMR) imaging performed three-to-five days after PCI was used to determine infarct size (IS) normalized to the area at risk (AAR). Results showed that the infarct size normalized to the area at risk was significantly lower in the delayed PCI group compared to the immediate PCI group (IS/AAR: 47±16 vs. 60±16, p=0.02), which translates to a 22% relative and 13% absolute reduction in IS/AAR.
“Results from this analysis are early, but promising, indicating that in STEMI patients, unloading the left ventricle with Impella CP for 30 minutes and delaying PCI could potentially help improve patient outcomes by reducing damage to the heart muscle and helping prevent heart failure,” said Dr. Kapur.
Myocardial damage can lead to heart failure. Every 5% increase in infarct size is associated with a 20% increase in relative hazard for all-cause mortality or hospitalization for heart failure within one year after a primary PCI (JACC, 2016). Coronary artery disease is the number one cause of death in the United States and 47% of women and 36% of men over the age of 45 will die within five years of their first heart attack (Circulation, 2019).
The STEMI DTU pilot study demonstrated for the first time that LV unloading using Impella CP with a 30-minute delay before reperfusion via PCI is feasible, safe and not associated with an increase in infarct size. The pilot study led to the STEMI DTU pivotal randomized controlled trial, which began in 2019 and is actively enrolling patients. The pivotal trial is testing the hypothesis that compared to PCI alone, LV unloading for 30 minutes prior to PCI can reduce myocardial damage and future heart failure-related events due to a heart attack.
ABOUT IMPELLA HEART PUMPS
The Impella 2.5® and Impella CP® with SmartAssist® are U.S. FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI), such as stenting or balloon angioplasty, to reopen blocked coronary arteries.
Impella 2.5, Impella CP®, Impella CP with SmartAssist, Impella 5.0®, Impella LD®, and Impella 5.5® with SmartAssist® are U.S. FDA approved to treat heart attack or cardiomyopathy patients in cardiogenic shock and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart.
Impella heart pumps are not FDA approved for use in STEMI patients without cardiogenic shock.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, Abiomed (Nasdaq: ABMD) is a leading provider of medical technology that provides circulatory support and oxygenation. Our products are designed to enable the heart to rest and recover by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure. For additional information, please visit abiomed.com.
FORWARD-LOOKING STATEMENTS
Any forward-looking statements are subject to risks and uncertainties such as those described in Abiomed's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220917005003/en/
Contact information
Media Contact:
Jenny Leary
Associate Director, U.S. Communications
+1 (978) 882-8491
jleary@abiomed.com
Investor Contact:
Todd Trapp
Executive Vice President and Chief Financial Officer
+1 (978) 646-1680
ttrapp@abiomed.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Takeda’s Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care28.3.2026 21:00:00 EET | Press release
Takeda(TSE:4502/NYSE:TAK)today announced new data from the two pivotal Phase 3studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented as a late-breaking abstract at the 2026 American Academy of Dermatology (AAD) Annual Meeting, these data show that convenient once-daily oral zasocitinib demonstrated rapid and durable skin clearance with a safety profile consistent with Phase 2b studies.1,2 “Our goal in psoriasis treatment is clear or almost clear skin, and previously this has been achieved primarily with injectable therapies,” said Melinda Gooderham, MSc, MD, FRCPC, dermatologist, SKiN Centre for Dermatology, Peterborough, Ontario, Canada, principal investigator for the Latitude PsO studies and presenting author. “These efficacy and safety results show it’s possible for a once-daily pill to deliver rapid, lasting skin clearance, highlighting the potential of zasoc
Incyte Announces New Positive 54-Week Late-Breaking Data for Povorcitinib in Hidradenitis Suppurativa at the 2026 American Academy of Dermatology (AAD) Annual Meeting28.3.2026 21:00:00 EET | Press release
Incyte (Nasdaq:INCY) today announced 54-week data evaluating the safety and efficacy of povorcitinib (INCB54707), an oral small-molecule highly-selective JAK1 inhibitor, from the pivotal Phase 3 STOP-HS clinical trial program in adult patients (≥18 years) with moderate to severe hidradenitis suppurativa (HS). The late-breaking oral presentation of these data is taking place at the 2026 American Academy of Dermatology (AAD) Annual Meeting, being held March 27-31, 2026, in Denver (Session: S034 – Late-Breaking Research: Session 2. Saturday, March 28, 2026, 1:00-4:00 p.m. MT). “The 54-week results from the STOP-HS program deliver compelling, long-term evidence supporting the potential of povorcitinib for patients with moderate to severe HS,” said Pablo J. Cagnoni, M.D., President and Global Head of Research and Development, Incyte. “Across both studies, povorcitinib demonstrated substantial and durable improvements over time in key measures of treatment success and meaningful clinical ben
AAD 2026: Late-Breaking Nemolizumab Data Demonstrate Clinically Meaningful Benefits for Children Aged 2 to 11 With Moderate-to-Severe Atopic Dermatitis28.3.2026 17:00:00 EET | Press release
Galderma (SIX: GALD) today announced new phase II data showing that nemolizumab was well tolerated and effective in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis, with a clinically meaningful and sustained reduction in skin lesions and itch for up to a year.1 Results will be presented in a late-breaking session at the 2026 American Academy of Dermatology (AAD) Annual Meeting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260328320362/en/ Atopic dermatitis is the most common inflammatory skin disorder in children, yet treatment options in the moderate-to-severe pediatric setting are limited.5 The disease can have a significant impact on quality of life for both the patients and their loved ones, with persistent itch and recurrent skin lesions often disrupting sleep, school and relationships.5-8 “Atopic dermatitis can affect many aspects of children’s lives including schoolwork, emotional development
Angelalign Technology (6699.HK) Releases 2025 Results: Passion for Clinical Excellence Drives Worldwide Growth27.3.2026 21:56:00 EET | Press release
Angelalign Technology Inc. (6699.HK) (“Angel” or the “Company”) released its financial results for fiscal year 2025. During the reporting period, the Company continued to do well in both the global and China markets. Total case volume was 532,400, which increased 48.1%, revenue was USD 370.3 million, which increased 37.8%, and adjusted net profit was USD 43.8 million, which increased 63.0%. The results were driven by Angel’s passion for clinical excellence and its open and inclusive culture that empowers talented people to work together to meet customer needs, the Company said. Fox Hu, CEO of Angel, stated: “The clear aligner industry is complex and multidisciplinary. It requires top-tier technical and operational talent along with seamless collaboration among professionals from diverse geographies. Angel’s open and inclusive culture attracts professionals who share a passion for clinical excellence and a dedication to bringing outstanding products and services to customers. This melti
Axway Positioned as a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment27.3.2026 19:46:00 EET | Press release
Axway, a 74Software company (Euronext: 74SW) and global leader in federated API management and enterprise integration, has been named a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment.1 Axway Amplify securely connects, orchestrates, and automates data integration. Organizations in financial services, manufacturing, healthcare, and other industries rely on Amplify to modernize integrations and confidently unlock data to deliver superior digital services faster. The report notes: “The platform benefits from Axway’s long-standing experience in B2B integration, secure file transfer, and legacy connectivity, providing differentiated capabilities for organizations that need to expose and control APIs around core systems that are not cloud-native.”1 This multi-pattern expertise in security, integration, and federated governance — built during the early phases of the API-driven digital transformation — becomes especially critical as enterprises seek to govern dat
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom