FDA Grants Breakthrough Device Designation for Neovasc's Reducer

October 10, 2018—Neovasc Inc. announced that the FDA has granted Breakthrough Device designation to the Neovasc Reducer, a device for the treatment of refractory angina that is not currently approved for commercial sale in the United States.

The company noted that the FDA grants Breakthrough Device designation in order to expedite the development and review of a device that demonstrates compelling potential to provide a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. To qualify as a Breakthrough Device, there must either be no FDA-approved treatments presently available or the technology must offer significant advantages over existing approved alternatives.

The Reducer received European CE Mark approval in the European Union for the treatment of refractory angina. The Reducer provides relief of angina symptoms by altering blood flow in the heart's circulatory system, thereby increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. Placement of the Reducer is performed using a transvenous procedure that is similar to implanting a coronary stent and is completed in approximately 20 minutes, stated Neovasc.