Cardiac Science gets FDA approval to commence Phase II trials of its AECD heart device.IRVINE, Calif.--(HealthWire)--June 15, 1995--Cardiac Science Inc. (OTC/Bulletin Board:DFIB) Thursday announced it has received approval from the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to commence Phase II human clinical trials of its non-surgical Powerheart 360j Automatic External Cardioverter Defibrillator Device (AECD AECD Automatic external cardioverter-defibrillator A device that monitors cardiac rhythm and automatically defibrillates ) designed to prevent Sudden Cardiac Death Sudden Cardiac Death Definition Sudden cardiac death (SCD) is an unexpected death due to heart problems, which occurs within one hour from the start of any cardiac-related symptoms. SCD is sometimes called cardiac arrest. (SCD ScD [L.] Scien´tiae Doc´tor (Doctor of Science). SCD 1 Sickle cell disease, see there 2 Subacute combined degeneration, see there 3 Sudden cardiac death, see there ) in high-risk heart patients. The approval received from the FDA allows Cardiac Science to conduct its initial Phase II trials on ten patients at one institution, with a progress report back to the FDA after the first five patients have been treated. Initial Phase II trials are expected to commence in the next quarter at the Arizona Heart Institute in Phoenix. Phase I testing was completed at the University of California, Irvine Medical Center The University of California, Irvine Medical Center (or UCI Medical Center) is a major research hospital located in the City of Orange. It is Orange County's central public hospital and the teaching center for the University of California, Irvine School of Medicine. in California, the Montefiore Medical Center Montefiore Medical Center, in the Bronx, New York, is the university hospital of the Albert Einstein College of Medicine. The hospital, named after Moses Montefiore, is one of the 50 largest employers in New York State [1]. in New York, and the Arizona Heart Institute in Phoenix. The device, when approved to market by the FDA, will be for bedside use in hospitals. The Powerheart 360j AECD device is programmable by the physician to meet the specific needs of the patient. Once the patient is attached to the device, the AECD is designed to monitor the heart, detect dangerous ventricular arrhythmias which cause SCD, and deliver therapy for extended periods of time without further human intervention. Therapy consists of corrective pulses of energy within seconds of the arrhythmias to restore normal heart rhythm. Cardiac Science is also developing two ambulatory devices for home use, one of which will be a device fully contained in a lightweight vest worn by the patient. Separate trials will be conducted for FDA approval of the ambulatory model devices. Cardiac Science is a publicly traded company publicly traded company A company whose shares of common stock are held by the public and are available for purchase by investors. The shares of publicly traded firms are bought and sold on the organized exchanges or in the over-the-counter market. trading on the OTC/Bulletin Board under the symbol DFIB. The company develops non-surgical and non-invasive bedside, mobile, and ambulatory automatic external cardioverter/defibrillator devices which are intended to treat life-threatening ventricular tachyarrhythmias that lead to SCD. CONTACT: Financial Sciences of America, Los Angeles Fran Daniels, 310/278-4413 |
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