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BRIEF-Neovasc To Explore HDE Approval Pathway And Alternate Trial Designs For The Reducer Following Guidance From The FDA

Published 2019-07-12, 09:32 a/m
BRIEF-Neovasc To Explore HDE Approval Pathway And Alternate Trial Designs For The Reducer Following Guidance From The FDA
NVCN
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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

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