Published In Peer-Reviewed Journal
VANCOUVER and MINNEAPOLIS, Jan. 18, 2022 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today announced the publication of a case series in the journal Cardiovascular Revascularization Medicine describing successful uses of the Neovasc Reducer™ (“Reducer”) under a compassionate use protocol in the United States. The patients were treated under the care of Ryan Gindi, M.D., and the procedures were performed by Gerald Koenig, M.D., Ph.D, both from the Division of Cardiology, Henry Ford Hospital, Detroit. Following the commencement of the COSIRA-II Trial in the United States, qualifying patients are now eligible to be treated in a clinical trial for the device.
“We are pleased to publish the one-year outcomes of the first two patients treated with the Reducer device in the United States,” stated Dr. Gindi. “As a clinical cardiologist in a large metropolitan practice, I am confronted with the challenges of treating patients with refractory angina every day. It’s gratifying to see the positive impact the Reducer device has had on our patients.”
The first patient treated with the Reducer is a 59-year-old male with diabetes suffering from severe coronary artery disease and debilitating refractory angina. The patient had a history of multiple stenting procedures, radiation therapy to treat blocked stents, and extensive medications to treat his chest pain. Despite all efforts to alleviate his anginal symptoms, he lived a significantly restricted lifestyle because of his chest pain. After implantation of the Reducer device, the patient became largely asymptomatic and did not require any further interventional therapy. He described walking several miles around Washington, D.C. without angina.
The second patient is another 59-year-old male with an extensive history of coronary artery disease who previously suffered multiple heart attacks, underwent coronary artery bypass surgery and had multiple stenting procedures to control his symptoms. Despite all efforts and extensive medications, he remained severely restricted by his angina, and was subsequently treated with the Reducer device. A year following the procedure, he described being able to ride a bicycle 35 miles on hilly terrain without angina.
“It’s encouraging to see such positive results on the first two patients treated with the Reducer in the United States,” said Dr. Koenig. “I have seen first-hand the positive impact that it can have on patients, and we are excited to participate in the COSIRA-II clinical trial at Henry Ford Hospital.”
COSIRA-II is a clinical trial designed to evaluate the safety and effectiveness of the Reducer in treating patients suffering from refractory angina. The randomized, double blinded, placebo-controlled trial will enroll approximately 380 patients in the United States and Canada at as many as 50 investigational sites. The primary endpoint of the trial is the change in exercise tolerance testing time measured at six months via a treadmill test.
“Now that the COSIRA-II clinical study is underway, we have the opportunity to bring the Reducer therapy to patients suffering from refractory angina in the United States,” commented Fred Colen, Chief Executive Officer at Neovasc. “It is rewarding to see such positive results on the early US patients treated under compassionate use.”