Neovasc Says FDA Approves Protocol Supplement for Angina Study
July 26 2022 - 9:20AM
Dow Jones News
By Michael Dabaie
Neovasc Inc. said the U.S. Food and Drug Administration approved
a protocol supplement to the COSIRA-II investigational device
exemption trial to allow the inclusion of additional patient
populations in the study.
The company said the approval expands the number of patients
eligible for treatment in the trial and adds two previously planned
imaging substudies into the safety and mechanism of action of the
Neovasc Reducer.
The COSIRA-II trial is looking at the safety and effectiveness
of the Reducer for patients suffering from refractory angina. The
primary objective of the trial is change in exercise tolerance
testing time between baseline and six-month follow-up.
The study is planned to randomize 380 patients at up to 50 sites
in the U.S. and Canada and the primary study analysis will still be
performed on the randomized population. The newly added arm allows
for up to 270 additional patients.
Neovasc said in a release that more than two million angiograms
are performed a year in the U.S., most of which are done on
patients with angina. Nearly 40% of patients receiving angiograms
don't have obstructive coronary artery disease. The newly added arm
in the COSIRA-II study provides an opportunity to study the Reducer
in the nonobstructive population, the company said.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
July 26, 2022 10:05 ET (14:05 GMT)
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