By Michael Dabaie
Neovasc Inc. said the US 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 followup.
The study is planned to randomize 380 patients at up to 50 sites in the US 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 US, 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 [email protected]
Credit: www.marketwatch.com /