FDA Reclassifies ECP Devices

FDA Reclassifies ECP Devices

EECP Devices have 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 devices have been categorized as a Class III device.

The Food & Drug Administration classifies medical devices into 3 Classifications based on the proven safety & efficacy from scientific evidence. 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 more than 100 published clinical trials to improve blood flow to the myocardium (heart muscle) by developing micro-vessel pathways around narrowed and blocked arteries.

For more information about the FDA Reclassification, please visit: ECP Industry News

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