Nine years after it won the CE Mark in Europe, the Neovasc (NSDQ:NVCN) Reducer device, designed to treat refractory angina, is close to an FDA decision on premarket approval.
The agency’s Circulatory Systems Devices Panel is scheduled to discuss the Reducer at a virtual meeting set for Oct. 27, the FDA announced today. In a corporate update published in August, Vancouver-based Neovasc said the panel will discuss the potential benefits and risks of Reducer therapy for U.S. patients and vote on whether the company’s PMA submission should proceed to a final decision by the agency. Neovasc said it is “enthusiastic” about the meeting.
The Reducer is designed to relieve angina symptoms by altering blood flow within the myocardium of the heart while increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. It can be placed in a minimally invasive transvenous procedure that is similar to implanting coronary stents.
The device is intended for patients who are unsuitable for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention, according to the FDA.
Neovasc announced in November 2019 that it would seek a PMA for the Reducer. The device was awarded the CE Mark in 2011.