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
HAZAMA ANDO Becomes an Official Partner in Helical Fusion’s Commercial Fusion Initiative and Signs MoU Toward Construction of the Fusion Pilot Plant6.7.2026 09:40:00 EEST | Press release
Helical Fusion Co., Ltd. (“Helical Fusion”), a Japan-based fusion energy startup developing fusion power plants, and HAZAMA ANDO CORPORATION (“HAZAMA ANDO”), a long-established Japanese general contractor, today announced that HAZAMA ANDO has become an Official Partner in the Helix Program, Helical Fusion’s commercial fusion initiative. The two companies have also signed a memorandum of understanding (“MoU”) to collaborate toward the construction of Helix KANATA, Helical Fusion’s Fusion Pilot Plant targeted for the 2030s. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260706176052/en/ (L-R) Kazuhiko Kuniya (Representative Director and President, HAZAMA ANDO CORPORATION) and Takaya Taguchi (Co-Founder and CEO, Helical Fusion Co., Ltd.) at a press conference in Tokyo on July 6, 2026. Fusion energy has the potential to shift the foundation of energy from natural resources to advanced technology by reproducing, on Earth, the sam
Sofinnova Partners Announces Myricx Bio Agrees to Be Acquired by Novartis6.7.2026 08:15:00 EEST | Press release
Sofinnova Partners, a leading European life sciences venture capital firm, today announced that its portfolio company Myricx Bio (“Myricx”) has reached agreement to be acquired by Novartis, for up to $1.5 billion including $1.1 billion cash upfront plus potential milestone payments. This marks Sofinnova Partners' seventh exit in three years. Myricx Bio is a UK-headquartered transatlantic biotech company focused on the discovery and development of a novel class of payloads for antibody-drug conjugates. The company's platform is built around next-generation N-myristoyltransferase inhibitor (NMTi) payloads, a differentiated mechanism of action designed to address the narrow therapeutic windows and tolerability challenges that have limited earlier generations of ADCs, such as TOPO-1 and tubulin inhibitor payload classes. Myricx Bio's two lead ADC assets, directed towards the established targets B7-H3 and HER2, are designed to bring this differentiated approach to patients across a broad ra
Global New Material International Wins Technology Innovation Best Practice Award at Sino-European ESG Conference6.7.2026 06:59:00 EEST | Press release
Global New Material International Holdings Ltd. has received the Technology Innovation Best Practice Award at the Third Sino-European Corporate ESG Best Practice Conference recently in Mainz, Germany, in recognition of its efforts to advance sustainable development through material innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260705533555/en/ Thorsten Giehler (L), Director of the Economic, Social Development and Employment Division of The German Society for International Cooperation (GIZ), delivered the award to Zhou Fangchao, Executive Director and Vice President of Global New Material International. The annual conference, initiated by the Chinese Consulate General in Frankfurt and jointly organized with Chinese and European partners, recognizes corporate best practices in environmental, social and governance (ESG) performance. This year's event brought together government officials, business leaders and exper
Access Advance Welcomes Samsung and Sharp to the VVC Advance Patent Pool6.7.2026 03:00:00 EEST | Press release
Access Advance LLC today announced significant additions to the VVC Advance Patent Pool, including Samsung Electronics and Sharp Corporation joining as both Licensors and Licensees. The additions strengthen Access Advance's position in VVC licensing, bringing two of the world's largest video codec patent holders into the program on both sides of the license. "The growth we are seeing in VVC Advance reflects the broad range of industries and companies that are moving toward VVC as the next standard for video delivery," said Peter Moller, CEO of Access Advance. "Samsung and Sharp joining as both Licensors and Licensees is significant, but so is the participation of leading smartphone brands and the range of consumer electronics and technology companies now executing licenses. We are building a program that reflects where the video market is actually heading." The following companies have joined the VVC Advance Patent Pool as Licensees since the beginning of 2026: American Future Technolo
Kioxia and Sandisk Begin Production of 10th-Generation 3D Flash Memory Products at Kitakami Plant Fab23.7.2026 13:19:00 EEST | Press release
Kioxia Corporation, a subsidiary of Kioxia Holdings Corporation (TOKYO: 285A) and Sandisk Corporation (Nasdaq: SNDK) today announced the start of production for their 10th-generation 3D Flash memory technology at Fab2 (K2) at the Kitakami Plant in Iwate Prefecture in Japan. The milestone comes as the companies continue to drive meaningful, multi-year bit growth to address the strong demand for their innovative flash memory technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260702296115/en/ Unveiling ceremony for the K2 facility In conjunction with the start of production, the companies held an unveiling ceremony for the K2 facility. Opening in September 2025, the facility has produced the companies’ 8th-generation 3D flash memory products and will begin to scale production with the introduction of their 10th-generation products. Both generations of 3D flash memory adopt innovative CBA (CMOS directly Bonded to Array)
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