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Neovasc Receives FDA Approval to Initiate Pivotal Reducer Trial

06-Nov-2017 | Source : Neovasc Inc. | Visits : 4197
VANCOUVER - Neovasc Inc. announced in a press release that it has received approval of the US Food and Drug Administration ("FDA") to initiate the COSIRA-II IDE pivotal clinical trial.  The trial's purpose will be to demonstrate the safety and effectiveness of the Company's novel Reducer system for treatment of patients with refractory angina. Once completed, the trial data is intended to support an application to the FDA for approval to begin marketing Reducer in the United States.

Refractory angina is a common and disabling clinical condition, and a major public health problem, which affects patients' quality of life, and has a significant impact upon health care resources. 

"Since its commercial launch in Europe two years ago, Reducer has consistently provided relief of severe symptoms in patients suffering from refractory angina, resulting in significant improvements in their quality of life," commented Neovasc CEO, Alexei Marko. "We are eager to replicate our European clinical and commercial success in the United States, by introducing this important new therapy for patients who have no other option for managing their chronic, severe chest pain."

COSIRA-II will be a 380 patient, multicenter, randomized (1:1 ratio), double blinded, sham-controlled clinical trial with up to 35 investigational centers across North America.  The COSIRA-II trial design is very similar to the COSIRA study, a 104 patient study previously conducted in Europe and Canada.  The positive results of that study were published in the New England Journal of Medicine, February 2015.

Neovasc is currently evaluating start up timelines and funding options for the COSIRA-II trial.

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