Source: Neovasc.
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  • Neovasc (NVCN) has enrolled the first patient in its COSIRA-II clinical trial
  • COSIRA-II will study the Neovasc Reducer™, designed to reduce angina symptoms in patients with refractory angina
  • Refractory angina is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year
  • The first patient was enrolled at St. Francis Hospital & Heart Center in Roslyn, NY
  • Neovasc is a specialty medical device company
  • Neovasc Inc. (NVCN) is up 1.6 per cent, trading at $0.64 at 10:15 am EST

Neovasc (NVCN) has enrolled the first patient in its COSIRA-II clinical trial.

COSIRA-II (COronary SInus Reducer for the Treatment of Refractory Angina) 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 to the U.S. Food and Drug Administration for approval of the Reducer device in the United States.

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.”

COSIRA-II is designed to evaluate the safety and effectiveness of the reducer in treating patients suffering from refractory angina.

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. 

“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,” 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 enrollment. Finalization of the reimbursement rate for the trial procedure will enable Medicare beneficiaries eligible for the trial to have greater access.”

The Reducer is CE-marked in the European Union and Under Investigation in the United States for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies.

Refractory angina is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.

Neovasc is a specialty medical device company that develops, manufactures and markets products for the cardiovascular marketplace.

Neovasc Inc. (NVCN) is up 1.6 per cent, trading at $0.64 at 10:15 am EST.

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