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Data Presented at TCT 2018 Shows Use of Impella and Best Practices Increases Cardiogenic Shock Survival
SAN DIEGO, Sept. 24, 2018 (GLOBE NEWSWIRE) -- A new analysis of data from Abiomed's (NASDAQ:ABMD) Impella® Quality (IQ) Database shows a relative increase of 24% in mean survival in acute myocardial infarction (AMI) cardiogenic shock patients since Impella’s cardiogenic shock FDA post-market approval. Part of the reason for the increase was a near doubling in the number of hospital centers achieving a greater than 80% survival to explant. This data was presented at the 30th Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego, Calif., by William O’Neill, MD, medical director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit.
“This real-world evidence shows an unprecedented increase in survival outcomes for AMI cardiogenic shock patients and is a result of the increased adoption of best practices for treating cardiogenic shock,” said Dr. O’Neill.
The analysis is based on 11,566 AMICS patients treated with Impella between April 2015 and June 2018 from Abiomed's IQ Database. The IQ Database is a collection of observational, quality assurance data on more than 95% of Impella patients since the Impella heart pump’s introduction to the United States.
From the IQ Database, three best practices were identified and adopted into treatment protocols at a growing number of hospitals through the physician-led National Cardiogenic Shock Initiative (NCSI). The best practices include placing Impella before percutaneous coronary intervention (PCI), reducing use of inotropes, and use of hemodynamic monitoring.
“We are seeing this improvement only a year and a half after these best practices were identified and championed. In my career, I haven’t before seen this kind of rapid change of outcomes in interventional cardiology,” said Dr. O’Neill. “Historically, survival rates for AMI cardiogenic shock have stagnated around 50%. The adoption of these best practices and the improvement in cardiogenic shock outcomes for so many patients is incredibly gratifying.”
Separately at TCT, Dr. O’Neill also presented initial data from the first 104 patients treated with the NCSI protocol. The data showed a 77% survival to discharge with 99% native heart recovery. The NCSI protocol includes placing Impella pre-PCI, reducing the use of inotropes, and right heart hemodynamic monitoring.
“Taken together, these two data analyses demonstrate how best practice protocols give us hope for improving survival rates in cardiogenic shock,” said Michael R. Minogue, chairman, president and chief executive officer of Abiomed. “Abiomed is committed to advancing clinical research and innovation to improve outcomes for our patients and send them home with their native heart.”
ABOUT IMPELLA HEART PUMPS
The Impella 2.5 and Impella CP devices are FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist, Impella 5.0® and Impella LD® are FDA approved heart pumps used 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. To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit: www.protectedpci.com.
The ABIOMED logo, ABIOMED, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, and Recovering hearts. Saving lives. are registered trademarks of ABIOMED, Inc. in the U.S. and in certain foreign countries.
Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com.
This release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities and expected regulatory approvals. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.
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