Neovasc has enrolled the first patient in a pivotal trial that will study the Neovasc Reducer’s ability to reduce angina symptoms in patients with refractory angina.

Data from the COronary SInus Reducer for the Treatment of Refractory Angina (COSIRA-II) will support a PMA application for the Reducer. The device has CE Mark.

COSIRA-II is a randomized, double blinded, placebo-controlled trial will enroll about 380 patients in the U.S. 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.

The first patient was enrolled at St. Francis Hospital & Heart Center, Roslyn, NY, under the care of Ziad Ali, M.D., DPhil., and Principal Investigator Evan Shlofmitz, D.O. The patient has a history of chronic refractory angina and previously endured multiple cardiac catheterization procedures at various hospitals to treat his recurrent symptoms. None of the previous procedures was successful at alleviating his chest pain.

"Enrollment of the first patient in COSIRA-II is a major step forward for patients in the United States suffering from chronic chest pain," stated COSIRA-II Executive Steering Committee member Allen Jeremias, M.D., St. Francis Hospital & Heart Center, Roslyn, NY. "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."

Neovasc began pouring a considerable amount of energy into the Reducer when it paused its Tiara transfemoral mitral valve replacement program in June. As a result, the company reduced 40% of its headcount.

In a June 2021 release the company said “while in the past, mitral valve replacement programs have been acquired after small, early feasibility studies, a series of high-profile failures and overall delays in the mitral valve replacement sector have highlighted the technical and clinical trial enrollment challenges for competitive programs. Today, potential acquirers are more cautious, and they are expecting programs to be approved or near approval before showing potential interest in acquiring a new mitral valve technology. Given this change in environment, the limited cash on hand, the overall market capitalization of the company, and the substantial time and cost of taking the Tiara TF program to approval, the company believes that pausing the Tiara TF program is the correct course of action.”