Neovasc has announced that the US Food and Drug Administration (FDA) has approved a protocol supplement to the COSIRA-II investigational device exemption (IDE) trial.
The approval expands the number of patients eligible for treatment in the trial and adds two previously planned imaging sub-studies designed to provide insights into the safety and mechanism of action of the Neovasc Reducer. The timing of the approval is ahead of the company’s internal target and will allow for additional patients to be treated.
The supplement adds a single, non-randomised arm to the existing protocol that allows enrolment of patients who are believed to benefit from Reducer implantation to reduce their angina symptoms, but who do not otherwise qualify for the randomised arm. These patients are well defined within the protocol and include patients with non-obstructive coronary artery disease who were previously ineligible for treatment. In addition, the expansion allows patients with predominantly right-sided ischemia, and those unable to perform a treadmill test due to amputation, to be included. All patients in the newly approved arm will receive a Reducer device per protocol. The two imaging sub-studies, utilising computed tomography (CT) and positron emission tomography (PET), aim to provide further support for the Reducer’s safety profile and mechanism of action.
“Today’s news is a big win for patients suffering from refractory angina,” national co-principal Investigator Tim Henry (Christ Hospital, Cincinnati, USA), commented. “I am pleased that these specific patients previously ineligible for the trial will now be able to be treated with the Reducer. The PET and CT sub-studies will give us important insights into the mechanism of action and safety of the Reducer, and the addition of patients with non-obstructive coronary disease will enable us to treat a much broader patient population.”
COSIRA-II is a randomised, double-blind, placebo-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 randomise 380 patients at up to 50 sites in the USA and Canada and the primary study analysis will still be performed on the randomised population. The newly added arm allows for up to 270 additional patients. There is no change to the sample size in the original randomised arm and Neovasc still expects to complete enrolment on schedule by the end of 2023.
“FDA approval of this IDE supplement is another important milestone for Neovasc and for patients suffering from angina,” commented Lisa Becker, Neovasc vice president of regulatory affairs. “We are particularly encouraged to investigate the Reducer in a population that disproportionately affects women. We appreciate the collaboration and rigor of FDA in the advancement of this important addition to the COSIRA-II trial.”