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"The reclassification of ECP devices is long overdue, and we thank FDA for confirming once again the safety and efficacy of ECP treatment of refractory angina in its class II decision," stated Dr. Jun Ma, President and CEO of Vasomedical, Inc. "Until this FDA final order, ECP systems, as a class III preamendments device, had been cleared for marketing in the U.S. by the 510(k) procedure, which only requires a demonstration of substantial equivalence. Consequently, certain manufacturers have been marketing their devices without much, if any, clinical evidence, which ultimately hurt the reputation of external counterpulsation therapy, a great technology if done right, as we have seen in numerous cases."
"The requirement of a PMA, which requires device-specific clinical evidence, for intended uses of ECP devices other than refractory angina is a positive development for Vasomedical and for patients that receive the therapy. We believe, since almost all of the publicly available scientific and clinical studies as published in peer reviewed medical journals and conferences were generated using Vasomedical EECP systems, there is sufficient clinical data for the Company to immediately proceed with the preparation of PMAapplications or PDP filings for certain indications other than refractory angina," Dr. Ma continued. "With this final order by FDA and given the breadth of clinical evidence for our EECP Therapy, we appreciate the opportunity to distinguish, from a regulatory standpoint now, our EECP Therapy system from other external counterpulsation (ECP) devices."
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