External Counterpulsation Therapy (also called ECP or EECP) has been reclassified as a Class II product by the Food & Drug Administration for severe Angina not amendable to surgery. This comes as big news to the External Counterpulsation Therapy industry as the ECP and EECP devices have been categorized as a Class III device. The U.S. Food and Drug Administration (FDA), Department of Health and Human Services, issued its final decision to reclassify ECP Therapy Devices for treatment of chronic stable angina for patients that are refractory to anti-anginal medical therapy and without options for revascularization.
The Food & Drug Administration classifies medical devices into 3 Classifications to regulate medical devices intended for human use based on proven safety & efficacy from scientific evidence. The system established three lcassifications of devices that signify the degree of regulation needed to assure that the devices are safe and effective. The classifications include Class I for general controls, Class II for special controls and Class III for newer devices that require premarket approval or PMA to demonstration safelty and effectiveness.
ECP and EECP Therapy has been proven to be an effective, non-invasive treatment solution for patients that suffer from symptoms of coronary artery disease. EECP Therapy is proven in nearly 200 published clinical trials to improve blood flow to the myocardium (heart muscle) by developing micro-vessel pathways around narrowed and blocked arteries.
The FDA’s reclassification of ECP devices is strictly for treatment of refractory angina that has been substantially proven in clinical research. The FDA’s move to reclassify the devices provides increased confidence of the evidence presented that ECP Therapy is a useful treatment option for this subset of patients. The ECP devices were previously classified as Class III.
There is more to this final decison to reclassify ECP Devices. The FDA included in its final ruling that other intended uses that were previously approved (unstable angina, acute myocardial infarction, cardiogenic shock and congestive heart failure) will require the filing of a PMA or complete a ‘product development protocol’ (PDP) to maintain the previously cleared uses cleared (510(k)) procedure. In accordance with federal regulations, ECP and EECP Companies 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.