Neovasc has announced that it has received Food and Drug Administration (FDA) approval for the investigational device exemption (IDE) regarding the COSIRA-II IDE clinical trial.
The study is designed to answer key questions arising from the 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 remains on track to enrol the first patient in the trial late this year.
COSIRA-II is a randomised, 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 enrol approximately 380 patients at up to 50 sites in the USA and will also include limited sites outside of the USA. The trial will include patients with Canadian Cardiovascular Society Class III-IV refractory angina on maximally tolerated medical therapy without further options for revascularisation via coronary intervention or bypass grafting. The principal investigators of the trial are Gregg Stone (Mount Sinai Health System, New York, USA) and Tim Henry (Christ Hospital, Cincinnati, USA).
FDA approval of the IDE Supplement is another important milestone for Neovasc, commented Lisa Becker, vice president of regulatory affairs, Global Angina Therapies, at Neovasc. “We are grateful for the collaborative work with FDA and we are pleased that our study initiation remains on track”, she continued. “Refractory angina is a debilitating condition, and we are excited to offer patients in the USA and Canada a clinical trial with a treatment option that may alleviate their suffering.”
The Reducer is CE-marked in the European Union and under investigation in the USA 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 revascularisation or cardiac drug therapies
While the Reducer is not approved for commercial use in the USA, the FDA granted Breakthrough Device designation to the Reducer in October 2018.
