Neovasc announces FDA Advisory Panel result on Neovasc Reducer medical device for the treatment of refractory angina.

Neovasc Inc. announced that the FDA’s Circulatory System Devices Advisory Panel voted 14 to 4 “in favor” that the Neovasc Reducer is safe when used as intended, and voted 1 to 17 “against” on the issue of a reasonable assurance of effectiveness. The third vote was 13 to 3 “against” (2 abstained) on whether the relative benefits outweighed the relative risks. The Reducer is currently under review by the agency for treatment of patients with refractory angina pectoris despite guideline directed medical therapy, who are unsuitable for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention. Concerns were expressed about a lack of data on long-term effects of the permanent implant, beyond six months, and some panelists were not confident in the device's mechanism of action. The stent-like device is implanted in the coronary sinus to modulate the outflow of oxygenated blood in the vein and redistribute it into areas of the heart with poor blood supply.