By Chris Wack

 

Neovasc Inc. said it has received approval from the Food and Drug Administration for the investigational device exemption regarding its Cosira-II IDE clinical trial.

The company said that following multiple discussions with the FDA over the past several months, the approved protocol for the study is designed to answer key questions arising from an October 2020 Circulatory Systems Devices Panel meeting regarding the Neovasc Reducer.

The approval of the supplement is consistent with Neovasc's internal target, and the company said it is on track to enroll the first patient in the trial late this year.

Cosira-II is a randomized, sham-controlled trial investigating the safety and effectiveness of the Reducer for patients suffering from refractory angina. The primary endpoint of the trial is change in exercise tolerance testing time via a modified Bruce protocol between baseline and six-month follow-up.

The study is planned to enroll 380 patients at up to 50 sites in the U.S. and will also include limited sites outside of the U.S., the company said.

Neovasc shares were up 15% to 85 cents in premarket trading.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

September 16, 2021 09:33 ET (13:33 GMT)

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