MONTVALE, N.J., Oct. 8, 2008 (GLOBE NEWSWIRE) -- Datascope Corp. (Nasdaq:DSCP) announced today that it will sponsor a 300-patient, randomized clinical trial in high-risk acute myocardial infarction (MI) patients who are not in cardiogenic shock to show the efficacy of intra-aortic balloon counterpulsation (IAB) in reducing infarct size. Patients enrolled in the CRISP* AMI trial will be randomized equally to usual care versus usual care plus intra-aortic balloon counterpulsation (IABC) therapy prior to percutaneous coronary intervention. The primary efficacy endpoint will be a 25% reduction in infarct size due to IABC utilization. The successful completion of this trial represents a worldwide opportunity of more than 200,000 patients, or $200 million per year.
By targeting at-risk patients in this study, the aim is to significantly reduce infarct size, thereby improving myocardial salvage. Infarct size is a well-established surrogate clinical marker for patient mortality, congestive heart failure and quality of life.
The basis for the trial is a 2007 animal study. This study concluded that "left ventricular unloading with IABC therapy prior to reperfusion reduces the extent of myocardial (damage)... These data suggest that in high-risk ST elevation myocardial infarction (STEMI) patients, IABP afterload reduction prior to reperfusion might be more beneficial than IABP placement post perfusion." This study has been published in the October 2008 issue of Catheterization and Cardiovascular Interventions.
The trial will be conducted at approximately 30 sites in the U.S., Europe and Australia.
Dr. Nino Laudani, Chief Operating Officer of Datascope, stated, "We believe that the successful completion of this myocardial salvage study will result in creating a new standard of care for STEMI patients and significantly increase the utilization of IAB therapy."
IABC therapy is currently the gold standard for a variety of clinical indications. It is a Class I indication for cardiogenic shock in the ACC/AHA guidelines.
* A multi-center, randomized, controlled study of mechanical left ventricular unloading with Counterpulsation to Reduce Infarct Size Pre-PCI for Acute Myocardial Infarction.
About Datascope Corp.
Datascope Corp. is the global leader of intra-aortic balloon counterpulsation and a diversified medical device company that develops, manufactures and markets proprietary products for clinical health care markets in interventional cardiology, cardiovascular and vascular surgery and critical care. The Company's products are sold throughout the world through direct sales representatives and independent distributors. Founded in 1964, Datascope is headquartered in Montvale, New Jersey. For news releases, webcasts and other Company information, please visit Datascope's website, http://www.datascope.com.
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