© Reuters. Neovasc on go with pivotal study of Reducer in angina patients; shares ahead 7%
- The FDA has signed off on a pivotal clinical trial, COSIRA-II, evaluating Neovasc ‘s (NVCN +6.9%) Reducer system in patients with refractory angina. The 380-subject study is similar to previously completed COSIRA.
- The Neovasc Reducer, placed via catheter akin to a stent procedure, helps relieve angina symptoms by altering blood flow in the circulatory system which increases the perfusion of oxygenated blood to areas of the heart that are not receiving sufficient blood flow.
- The CE Mark’d device was launched in Europe two years ago. Results from COSIRA-II will support a U.S. marketing application.