TransMedics Group Inc (TMDX)

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TransMedics Late Tuesday Announced FDA Advisory Committee Panel Voted 12 To 5 That Benefits Of OCS Heart System Outweigh Risks
6:58 am ET April 7, 2021 (Benzinga) Print
TransMedics Group, Inc. ("TransMedics") (NASDAQ:TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, announced today that after the review of TransMedics' clinical evidence from the OCS Heart EXPAND trial, the associated Continued Access Protocol ("CAP") results, as well as the OCS Heart PROCEED II trial, the Circulatory Systems Device Advisory Panel convened by the U.S. Food and Drug Administration ("FDA") has issued a favorable vote in support of approval of the OCS Heart System to the FDA's Office of Health Technology 2 (Cardiovascular Devices). The panel voted 12 to 5, with 1 abstaining, that the benefits of the OCS Heart System outweigh its risks. The panel voted 10 to 6, with 2 abstaining, that there is reasonable assurance that the OCS Heart System is effective. The panel voted 9 to 7, with 2 abstaining, that there is reasonable assurance of the OCS Heart System's safety.

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