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
INNIO Group Announces Filing of Registration Statement for Proposed Initial Public Offering11.5.2026 22:49:00 EEST | Press release
INNIO Group ("INNIO"), a leading global distributed energy solutions provider, today announces that it has publicly filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission ("SEC") relating to a proposed initial public offering of its common shares. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511389675/en/ INNIO Group Announces Filing of Registration Statement for Proposed Initial Public Offering The timing of the offering, number of shares to be offered and the price range for the proposed offering have not yet been determined. INNIO has applied to list its common shares on the Nasdaq Global Select Market under the ticker symbol "INIO." Goldman Sachs & Co. LLC, J.P. Morgan and Morgan Stanley are acting as joint lead book-running managers for the proposed offering. BofA Securities, Barclays and Citigroup are acting as book-running managers for the proposed offering. Baird, BNP Paribas
Only 7% of Companies Achieve Full Compliance as Global Expansion Increases Legal Complexity11.5.2026 16:00:00 EEST | Press release
As businesses accelerate their global expansion in 2026, compliance fails to keep pace. In fact, only 7% of organizations report full compliance across their global entities, according to a new study by CSC, the leading provider of global business administration and compliance solutions. CSC surveyed 350 general counsel (GCs) and senior legal professionals across Europe, North America, and Asia Pacific to examine how their teams navigate international expansion, regulatory pressure, and the increasing adoption of artificial intelligence (AI).¹ The findings appear in CSC’s latest report, General Counsel Barometer 2026: From Complexity to Control. Most organizations report partial compliance, with over half (53%) estimating they are 50–75% compliant, and a further 35% placing themselves between 76%–99%. This leaves just 7% of organizations reporting full compliance across all global entities. GCs also report low confidence in addressing ongoing demands amid global expansion. More than tw
IFF Opens Vanilla Innovation Center in Madagascar11.5.2026 15:15:00 EEST | Press release
IFF (NYSE: IFF)—a global leader in flavors, fragrances, food ingredients, health & bioscience—today announced the opening of its Vanilla Innovation Center in Madagascar, reinforcing vanilla as a strategic and priority tonality for IFF and strengthening its ability to innovate at origin. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260508110162/en/ IFF's Vanilla Innovation Center in Madagascar “The opening of the center marks an important step in how we approach vanilla innovation,” said Adam Jańczuk, Ph.D., senior vice president, research, creation and design, Taste, IFF. “By strengthening our presence at origin, we connect science, creativity and sustainability more closely, responding to climate changes, safeguarding quality and creating value across the supply chain.” Located in Toamasina, Madagascar’s principal seaport, near vanilla growing areas and post‑harvest processing activities, the 650‑square‑meter center bring
ARIS Recognised as a Leader in Gartner ® Magic Quadrant™ for Process Intelligence Platforms, Believes This Reinforces Its Role in Enabling Enterprise AI at Scale11.5.2026 15:00:00 EEST | Press release
ARIS, the process context foundation platform for enterprise AI deployment, today announced its recognition as a Leader in the Gartner® Magic Quadrant™ for Process Intelligence Platforms. This is the fourth consecutive year that ARIS has been recognized as a Leader in the report and the company believes it underscores a continued commitment to innovation and growth as enterprises focus on turning AI ambition into measurable business outcomes. While technology has advanced rapidly, companies are struggling to operationalise AI across complex operating models. ARIS sees this recognition by Gartner as a reflection of its strength in delivering a single unified platform for process intelligence, providing the context layer on which G2000 organisations can successfully deploy and scale agentic AI. “AI is moving from experimentation to execution – but many enterprises are finding it difficult to scale,” said Guillaume Bacuvier, CEO of ARIS. “The reason is simple: AI lacks the context it need
Logistics Reply Named a Visionary in 2026 Gartner® Magic Quadrant™ for Warehouse Management Systems and Ranks #2 for Level 2 and #3 for Level 3 Operations Use Cases in Gartner® Critical Capabilities Report11.5.2026 15:00:00 EEST | Press release
Logistics Reply, the Reply Group company specializing in innovative solutions for supply chain execution, is proud to announce its recognition as a Visionary in the Gartner® Magic Quadrant™ for Warehouse Management Systems for the seventh consecutive year, as its global team of warehouse technology professionals continues to drive innovation that puts customers first. Additionally, Logistics Reply for its LEA Reply™ WMS is recognized in the 2026 Gartner® Critical Capabilities for Warehouse Management Systems report where it ranked #2 for Level 2 Warehouse Operations and #3 for Level 3 Warehouse Operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511344452/en/ We believe these important recognitions underscore Logistics Reply's commitment to delivering intelligent, flexible and scalable warehouse execution solutions for enterprise customers around the world. For us, our placement in the Visionaries Quadrant reflects
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