GAITHERSBURG, Maryland — The circulatory systems advisory committee met to review the regulatory status of external counter-pulsation (ECP) devices and affirmed the FDA proposal that ECPs be slotted as class II devices for chronic stable angina. However, both agency and advisory committee indicated a preference that the device's use in other indications, including congestive heart failure, be slotted as class III devices, requiring a PMA. Read More
