FDA Approves Pivotal COSIRA-II Trial for Neovasc’a Reducer System
November 6, 2017—Neovasc Inc. announced that it has received approval from the US Food and Drug Administration (FDA) to initiate the COSIRA-II pivotal trial under an investigational device exemption. The trial's purpose will be to demonstrate the safety and effectiveness of the company's Reducer system for treatment of patients with refractory angina. When the trial is completed, the data are intended to support an application to the FDA for approval to begin marketing Reducer in the United States.
According to the company, COSIRA-II will be a multicenter, randomized (1:1 ratio), double-blinded, sham-controlled clinical trial that will enroll 380 patients at up to 35 investigational centers across North America. Neovasc is currently evaluating start-up timelines and funding options for the COSIRA-II trial.
The COSIRA-II trial design is similar to the COSIRA study, which was a 104-patient study conducted in Europe and Canada. In February 2015, the positive results of that study were published by Stefan Verheye, MD, et al in The New England Journal of Medicine (2015;372:519–527).
The company advised that the Reducer has received European CE Mark approval for the treatment of refractory angina. The Reducer can provide relief of angina symptoms by altering blood flow in the heart's circulatory system, thereby increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle.