Neovasc Gets FDA Approval for Reducer Clinical Trial
September 16 2021 - 9:48AM
Dow Jones News
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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