TransMedics Announces Positive FDA Advisory Committee ... | 合法醫療器材資訊網
2021年4月6日—Thepanelvoted10to6,with2abstaining,thatthereisreasonableassurancethattheOCSHeartSystemiseffective.Thepanelvoted9to7,with ...
ANDOVER, Mass., April 6, 2021 /PRNewswire/ -- TransMedics Group, Inc. ("TransMedics") (Nasdaq: TMDX[1]), 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 FDAs 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 effe...
CSDP April 6 | 合法醫療器材資訊網
Donor Heart Preserver Survives Review by FDA Advisors ... | 合法醫療器材資訊網
FDA advisory committee positive about TransMedics' OCS ... | 合法醫療器材資訊網
OCS Heart for HCP's | 合法醫療器材資訊網
Questions for the Advisory Committee meeting for the ... | 合法醫療器材資訊網
TransMedics Announces Positive FDA Advisory ... | 合法醫療器材資訊網
TransMedics Announces Positive FDA Advisory Committee ... | 合法醫療器材資訊網
TransMedics' 'heart in a box' donor organ preservation system ... | 合法醫療器材資訊網
TransMedics® Organ Care System™ (OCS) Heart System | 合法醫療器材資訊網
TransMedics® Organ Care System™ OCS Heart User Guide | 合法醫療器材資訊網
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