July 12 (Reuters) - Neovasc Inc NVCN.TO :
* NEOVASC TO EXPLORE HDE APPROVAL PATHWAY AND ALTERNATE TRIAL DESIGNS FOR THE REDUCER FOLLOWING GUIDANCE FROM THE FDA
* NEOVASC - FDA HAS RECOMMENDED CO TO CONSIDER ALTERNATE APPROACHES SUCH AS: HUMANITARIAN DEVICE EXEMPTION PATHWAY OR ALTERNATE CLINICAL TRIAL DESIGNS
* NEOVASC INC - COMPANY HAS DECIDED TO EXPLORE A TWO-PRONGED APPROACH
* NEOVASC INC - WILL EXPLORE AN ALTERNATE IDE STUDY DESIGN, IN CONJUNCTION WITH OUR SUPPORTIVE U.S. CARDIOLOGISTS
* NEOVASC INC- WILL WORK WITH FDA TO PURSUE OPTION FOR REDUCER TO BE CLASSIFIED AS HUMANITARIAN USE DEVICE SEEKING AN HDE APPROVAL PATHWAY
* NEOVASC - WILL EVALUATE AN ALTERNATE INVESTIGATIONAL DEVICE EXEMPTION ("IDE") CLINICAL TRIAL DESIGN FOR CLASS III AND IV PATIENTS