VANCOUVER and MINNEAPOLIS, July 26, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – Neovasc, Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN) today announced the United States Food and Drug Administration (“FDA”) has approved a protocol supplement to the COSIRA-II Investigational Device Exemption (“IDE”) Trial. The approval expands the number of patients eligible for treatment in the trial and adds two previously planned imaging sub-studies designed to provide insights into the safety and mechanism of action of the Neovasc Reducer™ (“Reducer”). The timing of the approval is ahead of the Company’s internal target and will allow for additional patients to be treated.
Read more at globenewswire.comNeovasc Announces FDA Approval of Planned COSIRA II Sub-studies and Single Arm Registry to Allow Inclusion of Additional Specified Patient Populations
Globe Newswire - Press Release
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