Neovasc (NVCN) announces the publication of a series of cases on the first American reduction implants
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Neovasc Inc. (NASDAQ: NVCN) today announced the publication of a series of cases in the journal Cardiovascular Revascularization Medicinedescribing successful uses of the Neovasc Reducer™ (“Reducer”) under a compassionate use protocol in the United States. Patients were treated under the care of Ryan Gindi, MD, and procedures were performed by Gerald Koenig, MD, Ph.D, both of the Division of Cardiology, Henry Ford Hospital, Detroit. Following the start of the COSIRA-II trial in the United States, eligible patients are now eligible to be treated in a clinical trial for the device.
“We are pleased to report one-year results from the first two patients treated with the Reducer device in the United States,” said Dr. Gindi. “As a clinical cardiologist in a large metropolitan practice, I face the challenges of treating patients with refractory angina every day. It is 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 diabetic man with severe coronary artery disease and debilitating refractory angina. The patient had a history of multiple stenting procedures, radiation therapy to treat blocked stents, and numerous medications to treat his chest pain. Despite all efforts to relieve his anginal symptoms, he led a significantly restricted life due to his chest pain. After implantation of the Reducer device, the patient became largely asymptomatic and required no further interventional treatment. He described walking several miles around Washington, DC without angina.
The second patient is another 59-year-old man with a long history of coronary artery disease who has previously suffered multiple heart attacks, had coronary bypass surgery, and undergone several stenting procedures to control his symptoms. Despite all efforts and numerous medications, he remained severely limited by his angina pectoris and was subsequently treated with the Reducer device. A year after the procedure, he described being able to cycle 35 miles over hilly terrain without sore throat.
“It is encouraging to see such positive results on the first two patients treated with the Reducer in the United States,” said Dr. Koenig. “I’ve seen firsthand the positive impact this can have on patients, and we’re 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 efficacy of the reducer in the treatment of patients with refractory angina. The randomized, double-blind, placebo-controlled trial will enroll approximately 380 patients in the United States and Canada at no less than 50 research sites. The primary endpoint of the trial is the change in duration of exercise tolerance testing measured at six months via a treadmill test.
“Now that the COSIRA-II clinical study is underway, we have the opportunity to bring Reducer therapy to patients with refractory angina in the United States,” commented Fred Colen, CEO of Neovasc. “It is gratifying to see such positive results in the first US patients treated under compassionate use.”