Neovasc has announced enrolment of the first patient in the COSIRA-II clinical trial.
COSIRA-II (COronary SInus Reducer for the Treatment of Refractory Angina) is a pivotal trial that will study the Neovasc Reducer, designed to reduce angina symptoms in patients with refractory angina. The results of this study will complement existing international safety and effectiveness data and support a pre-market approval application (PMA) to the US Food and Drug Administration (“FDA”) for approval of the Reducer device in the USA.
The first patient was enrolled at St Francis Hospital & Heart Center, Roslyn, USA, under the care of Ziad Ali, and principal investigator Evan Shlofmitz. 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.
“Enrolment of the first patient in COSIRA-II is a major step forward for patients in the USA suffering from chronic chest pain,” stated COSIRA-II Executive Steering Committee member Allen Jeremias, St. Francis Hospital & Heart Center, Roslyn, USA. “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.”
COSIRA-II is designed to evaluate the safety and effectiveness of the Reducer in treating patients suffering from refractory angina. The randomised, double blinded, placebo-controlled trial will enrol approximately 380 patients in the USA 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.
“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 USA during the clinical trial,” commented Fred Colen, chief executive officer at Neovasc. “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 enrolment. Finalisation of the reimbursement rate for the trial procedure will enable Medicare beneficiaries eligible for the trial to have greater access.”