Neovasc (NSDQ:NVCN) announced today that it enrolled the first patient in the Cosira-II clinical trial for its Neovasc Reducer.
Vancouver, Canada-based Neovasc’s Cosira-II (coronary sinus reducer for the treatment of refractory angina) pivotal trial will study the safety and effectiveness of the Reducer in reducing angina symptoms in those with refractory angina.
According to a news release, study results will complement existing international safety and effectiveness data and support Neovasc’s premarket approval (PMA) application to the FDA to commercialize the Reducer device in the U.S.
Neovasc designed the Cosira-II trial as a randomized, double-blind, placebo-controlled study that will enroll approximately 380 patients across as many as 50 investigational sites in the U.S. and Canada. The study has a primary endpoint set as the change in exercise tolerance testing time measured at six months via a treadmill test.
The first patient in the trial was enrolled at St. Francis Hospital & Heart Center (Roslyn, New York) under Dr. Ziad Ali and principal investigator Dr. Evan Shlofmitz. The patient has a history of chronic refractory angina and previously endured multiple cardiac catheterization procedures for treatment, with none successful in alleviating his chest pain.
“We are pleased to commence Cosira-II and grateful that the Centers for Medicare and Medicaid Services has determined the device and the procedure are eligible for reimbursement in the United States during the clinical trial,” Neovasc CEO Fred Colen said in the release. “The coverage determination is a big win for us. Cosira-II is a major investment for the company.
“We are grateful to our staff and the investigators for their relentless work to finalize all the required deliverables on schedule, such as FDA approval, local hospital review board approval, qualification processes, site training, and all required legal contracts and documentation by the end of 2021, enabling this first enrollment. Finalization of the reimbursement rate for the trial procedure will enable Medicare beneficiaries eligible for the trial to have greater access.”