Neovasc’s COSIRA-II IDE Trial Approved by FDA

September 16, 2021—Neovasc Inc. announced that it has received FDA approval of an investigational device exemption (IDE) for the COSIRA-II IDE clinical trial for the Neovasc Reducer device for the treatment of refractory angina. The approval comes after the company’s filing of a supplement for the trial with the FDA, which was reported on August 17.

According to Neovasc, the approval of the supplement is consistent with the company’s internal target for the study with enrollment expected to begin in late 2021.

The approved protocol for the COSIRA-II study is designed to answer key questions arising from the October 2020 Circulatory Systems Devices Panel Meeting regarding the Neovasc Reducer. In January 2021, Neovasc advised that it had received a not-approvable letter from the FDA regarding the company’s premarket approval submission for the Neovasc Reducer for the treatment of refractory angina. The device has been commercially available in Europe since 2015.

The COSIRA-II is a randomized, sham-controlled trial investigating the safety and effectiveness of the Reducer for treating patients with refractory angina. The primary endpoint of the trial is change in exercise tolerance testing time via a modified Bruce protocol between baseline and 6-month follow-up.

The study will enroll approximately 380 patients at up to 50 sites in the United States and will also include limited sites outside of the United States. The trial will include patients with Canadian Cardiovascular Society Class III to IV refractory angina on maximally tolerated medical therapy without further options for revascularization via coronary intervention or bypass grafting.

The Principal Investigators of the trial are Gregg Stone, MD, from Mount Sinai Health System in New York, New York, and Tim Henry, MD, from Christ Hospital in Cincinnati, Ohio.