Neovasc Submits Protocol Supplement to FDA for COSIRA-II Trial of Reducer System

August 17, 2021—Neovasc Inc. announced that it has filed a supplement to the COSIRA-II investigational device exemption (IDE) study with the FDA.

Following multiple productive discussions with FDA over the past several months, the protocol for the previously approved COSIRA-II study has been supplemented in consideration of additional experience and key questions arising from the October 2020 Circulatory Systems Devices Panel Meeting regarding the Neovasc Reducer system, advised the company.

In January 2021, the company announced that it received a not-approvable letter from the FDA regarding the company’s premarket approval submission for the Reducer for the treatment of refractory angina. The FDA granted Breakthrough Device designation for the Reducer system in October 2018.

The device, which received CE Mark approval, has been commercially available in Europe since 2015. Placement of the Reducer is performed using a minimally invasive transvenous procedure stent and can be completed in approximately 20 minutes.

According to Neovasc, COSIRA-II is a randomized, sham-controlled trial investigating the safety and effectiveness of the Reducer for patients with refractory angina. The proposed 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 is planned to enroll approximately 380 patients at up to 50 sites primarily in the United States. The trial will include patients with Canadian Cardiovascular Society Class III-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, of Mount Sinai Health System in New York, New York, and Tim Henry, MD, of Christ Hospital in Cincinnati, Ohio.

“Submission of the IDE supplement is an important step as we work towards commencing the trial this year,” commented Lisa Becker in the company’s announcement. Becker, who is Vice President of Regulatory Affairs, Global Angina Therapies, at Neovasc, continued, “Our intention is to run a definitive trial that will provide the clinical evidence to answer the outstanding questions from the FDA. The input from the COSIRA-II Executive Steering Committee as well as the discussions with FDA have been instrumental in our efforts to initiate and advance this trial.”