Neovasc’s Planned COSIRA II Substudies and Single-Arm Registry Receive FDA Approval

August 9, 2022—Neovasc, Inc. recently announced that the FDA has approved a protocol supplement to the COSIRA-II investigational device exemption (IDE) trial.

The company stated that the approval expands the number of patients eligible for treatment in the trial and adds two previously planned imaging substudies 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, noted Neovasc.

According to the company, the newly approved supplement adds a single, nonrandomized arm to the existing protocol that allows enrollment of patients who are believed to benefit from Reducer implantation to reduce their angina symptoms, but who do not otherwise qualify for the randomized arm. These patients are well defined within the protocol and include patients with nonobstructive 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 because of amputation, to be included.

All patients in the newly approved arm will receive a Reducer device per protocol. The two imaging substudies, utilizing CT and positron emission tomography (PET), aim to provide further support for the Reducer’s safety profile and mechanism of action.

Tim Henry, MD, of Christ Hospital in Cincinnati, Ohio, is the national coprincipal investigator of COSIRA II.

“Today’s news is a big win for patients suffering from refractory angina,” commented Dr. Henry in Neovasc’s press release. “I’m pleased that these specific patients previously ineligible for the trial will now be able to be treated with the Reducer. The PET and CT substudies will give us important insights into the mechanism of action and safety of the Reducer, and the addition of patients with nonobstructive coronary disease will enable us to treat a much broader patient population.”

COSIRA-II is a randomized, double-blind, placebo-controlled trial investigating the safety and effectiveness of the Reducer for patients with refractory angina. The trial’s primary endpoint is a change in exercise tolerance testing time via a modified Bruce protocol between baseline and 6-month follow-up.

The study is planned to randomize 380 patients at up to 50 sites in the United States and Canada.

The company advised that the primary study analysis will still be performed on the randomized population. The newly added arm allows for up to 270 additional patients. There is no change to the sample size in the original randomized arm and Neovasc still expects to complete enrollment on schedule by the end of 2023.

Neovasc’s Reducer is designed to alter blood flow within the myocardium of the heart and increase the perfusion of oxygenated blood to ischemic areas of the heart muscle, which may provide relief of angina symptoms. In the European Union, the Reducer has received CE Mark approval for the treatment of refractory angina. Reducer is investigational in the United States in the COSIRA-II clinical trial, advised the company.