Neovasc has supplemented the protocol for the previously approved COSIRA-II study, after discussions with the US FDA for several months
COSIRA-II is an IDE trial of Neovasc Reducer. (Credit: StockSnap from Pixabay.)
Neovasc has filed a supplement to the COSIRA-II Investigational Device Exemption (IDE) study with the US Food and Drug Administration (FDA) for its Neovasc Reducer.
The protocol for the previously approved COSIRA-II study has been supplemented following multiple productive discussions with the FDA over the past several months.
Neovasc said that the filing was supported by additional experience and questions arising from the Circulatory Systems Devices Panel Meeting regarding its Reducer device.
Neovasc global angina therapies regulatory affairs vice president Lisa Becker said: “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.
“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.”
The company’s Reducer is CE-marked in the European Union and currently under investigation in the US for the treatment of refractory angina, a painful heart condition.
Angina occurs when the coronary arteries fail to supply adequate volume of blood to the heart muscle, despite treatment with revascularisation or cardiac drug therapies.
Reducer is said to provide relief from angina symptoms by altering blood flow within the myocardium, increasing the blood supply to ischemic areas of the heart muscle.
COSIRA-II is a randomised, sham-controlled trial evaluating the safety and effectiveness of the Neovasc Reducer in patients suffering from refractory angina.
The company said that change in exercise tolerance testing time through a modified Bruce protocol between baseline and six-month follow-up is the proposed primary endpoint of the clinical trial.
The study is designed to enrol around 380 patients at up to 50 sites initially in the US.
It also will include patients with Canadian Cardiovascular Society (CCS) Class III-IV refractory angina, who are on medical therapy and without options for revascularisation.
In the study, Reducer is placed using a minimally invasive transvenous procedure that is similar to implanting a coronary stent and can be completed in approximately 20 minutes.
Reducer is not approved for commercial use in the US, but was granted FDA Breakthrough Device designation in October 2018.