Neovasc Inc. files premarket approval application to FDA for Neovasc Reducer medical device for the treatment of refractory angina.

Neovasc Inc., a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, announced the submission of a Premarket Approval application ("PMA") to the FDA for its Neovasc Reducer ("Reducer") medical device for the treatment of refractory angina. The submission also includes a request for an Advisory Panel meeting. The PMA for Reducer includes clinical data from the COSIRA 104 patient randomized, double-blind, sham-controlled trial, the ongoing REDUCER-I European Post-Market study, with over 200 patients currently enrolled with up to 5 years of follow-up, and supportive clinical evidence from multiple peer reviewed publications on Reducer. Comment: The Reducer is intended to provide relief of refractory angina symptoms by altering blood flow in the coronary sinus vein and thereby increasing perfusion of oxygenated blood to certain areas of the heart muscle that receive an inadequate supply of oxygen. Placement of the Reducer is performed using a minimally invasive percutaneous procedure that is similar to implanting a coronary stent and takes 20 minutes or less. The Reducer received a CE Mark in November 2011.