Medical device company Neovasc Inc (NASDAQ:NVCN) (TSX:NVCN) reported on Wednesday the US Food and Drug Administration's (the FDA) breakthrough device designation for the Neovasc Reducer (the Reducer) in order to expedite the development and review of the device for the treatment of refractory angina.
The company stated that Reducer is not currently commercially available in the US, but has been commercially available in Europe since 2015.
According to the company, refractory angina is a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. 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.
In conjunction, the placement of the Reducer is performed using a minimally invasive transvenous procedure that is similar to implanting a coronary stent and is completed in approximately 20 minutes, concluded the company.
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