Submission of COSIRA-II Protocol Supplement to FDA VANCOUVER and MINNEAPOLIS, Aug. 17, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Neovasc Inc. (“Neovasc” or the “Company”) (Nasdaq, TSX: NVCN) announced today that it has filed a supplement to the COSIRA-II Investigational Device Exemption (IDE) Study with the U.S. Food and Drug Administration (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™ (“Reducer”).
COSIRA-II is a randomized, sham-controlled trial investigating the safety and effectiveness of the Reducer for patients suffering from 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 (CCS) 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, M.D., Mt. Sinai Health System, New York, NY and Tim Henry, M.D., Christ Hospital, Cincinnati, OH.
According to literature, COSIRA-II will be the largest sham-controlled device trial in the history of coronary artery disease studies.(1) “Submission of the IDE Supplement is an important step as we work towards commencing the trial this year. Our intention is to run a definitive trial that will provide the clinical evidence to answer the outstanding questions from the FDA,” commented Lisa Becker, Vice President of Regulatory Affairs, Global Angina Therapies, at Neovasc. “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.”
About Reducer
The Reducer is CE-marked in the European Union and Under Investigation in the United States for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms, and its incidence is growing. The Reducer provides relief of angina symptoms by altering blood flow within the myocardium of the heart and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. Placement of the Reducer is performed using a minimally invasive transvenous procedure that is similar to implanting a coronary stent and can be completed in approximately 20 minutes.
While the Reducer is not approved for commercial use in the United States, the FDA granted Breakthrough Device designation to the Reducer in October 2018.
Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops, manufactures, and markets products for the rapidly growing cardiovascular marketplace. The Company is a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the treatment of refractory angina. Its products include the Neovasc Reducer™, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and Tiara™, for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel, and Europe. For more information, visit: www.neovasc.com.