Neovasc’s COSIRA-II Pivotal Trial of Reducer Device Begins Enrollment

January 5, 2022—Neovasc Inc. announced enrollment of the first patient in the pivotal COSIRA-II clinical trial of the company’s coronary sinus Reducer device for the treatment of refractory angina. The results of this study will complement existing international safety and effectiveness data and support a premarket approval application to the FDA for approval of the Reducer device in the United States. The Neovasc Reducer device is designed to reduce angina symptoms in patients with refractory angina.

COSIRA-II is designed to evaluate the safety and effectiveness of the Reducer in treating patients with refractory angina. In September 2021, Neovasc announced FDA approval of an investigational device exemption (IDE) for the clinical trial. The IDE approval was received after the company’s filing of a supplement for the trial with the FDA that was reported in August.

According to Neovasc, 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 6 months via a treadmill test.

The first patient in the trial was enrolled at St. Francis Hospital & Heart Center in Roslyn, New York, under the care of Ziad Ali, MD, and Principal Investigator Evan Shlofmitz, DO.

The company noted that this initial patient has a history of chronic refractory angina and previously underwent multiple cardiac catheterization procedures at various hospitals to treat his recurrent symptoms. None of the previous procedures was successful at alleviating his chest pain.

Allen Jeremias, MD, from St. Francis Hospital & Heart Center, is a COSIRA-II Executive Steering Committee member.

“Enrollment of the first patient in COSIRA-II is a major step forward for patients in the United States suffering from chronic chest pain,” commented Dr. Jeremias in Neovasc’s press release. “For the first time, patients that experience the debilitating effects of refractory angina have access to an FDA-designated ‘Breakthrough Medical Device’ in a placebo-controlled trial. The COSIRA-II trial offers hope for patients that previously had a poor prognosis and faced a future of unrelenting chest pain.”