Vasomedical has announced that the US Food and Drug Administration (FDA), Department of Health and Human Services, issued its final order on 30 December 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 infarction, cardiogenic shock and congestive heart failure, which were previously cleared for marketing by means of premarket notification (510(k)) procedure.
In accordance with federal regulations, ECP manufacturers may continue to commercially distribute their devices for these intended uses for a period of 90 days after the issuance of the final order. The devices may continue to be marketed only for refractory angina if a PMA or a notice of completion of a PDP is not filed before the end of the 90-day period.
Vasomedical president and CEO Dr. Jun Ma noted the reclassification of ECP devices is long overdue, and the company thanks FDA for confirming once again the safety and efficacy of ECP treatment of refractory angina in its class II decision.
"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 PMA applications or PDP filings for certain indications other than refractory angina.
"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," Dr Ma added.