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FDA Reclassifies ECP Devices for Refractory Angina as Class II
Date:1/6/2014

WESTBURY, N.Y., Jan. 6, 2014 /PRNewswire/ -- Vasomedical, Inc. ("Vasomedical") (OTCBB: VASO), a diversified medical technology company specializing in the design, manufacture and sale of medical devices including EECP® (Enhanced External Counterpulsation) Therapy systems, the gold standard of ECP therapy, announced today that the U.S. Food and Drug Administration (FDA), Department of Health and Human Services, issued its final order on December 30, 2013, reclassifying external counter-pulsating (ECP) devices for treatment of chronic stable angina for patients that are refractory to anti-anginal medical therapy and without options for revascularization from class III to class II (special controls).

Under a number of federal regulations, FDA administers a comprehensive system for the regulation of medical devices intended for human use.  The system established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness, namely general controls (class I), special controls (class II) and premarket approval or PMA (class III).  FDA's reclassification of ECP devices for treatment of refractory angina, which was a preamendments class III device, into class II is based upon its conclusion that the available scientific evidence is adequate to support the safety and effectiveness of ECP devices for this specific intended use.

In addition, FDA in the final order is requiring the filing of a PMA or a notice of completion of a product development protocol (PDP) for ECP devices for other intended uses such as unstable angina, acute myocardial infa
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SOURCE Vasomedical, Inc.
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