Neovasc said it received FDA administrative acceptance review notification for its Reducer device.
Reducer is designed to treat refractory angina, which occurs when the coronary arteries deliver an inadequate supply of blood to the heart.
“I would like to reiterate my thanks to the entire Neovasc team for their tireless efforts to complete the submission on time, and according to our plan. This is another positive step forward for Neovasc as we seek to bring the Reducer to the U.S. market,” president and CEO Fred Colen said in a news release. “The FDA conducted an administrative acceptance review of our Premarket Approval Application, submitted Dec. 30, 2019, and found it contained all of the necessary elements and information needed to proceed with the filing review.”
The Neovasc Reducer offers relief of 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. The device can be placed in a minimally invasive transvenous procedure that is similar to implanting coronary stents.