Donor Heart Preserver Survives Review by FDA Advisors ... | 合法醫療器材資訊網
2021年4月7日—TheTransMedicsOrganCareSystem(OCS)HeartSystemgotclosertoregulatoryapprovalasitemergedvictoriousfromacontentiousFDA ...
The TransMedics Organ Care System (OCS) Heart System got closer to regulatory approval as it emerged victorious from a contentious FDA advisory committee meeting[1].
Members of the agencys Circulatory System Devices Panel voted 12-5 (with one abstention) that the OCS Heart Systems benefits outweigh its risks as a device that could potentially widen the pool of donor hearts -- perhaps even reduce waitlist times -- by preserving non-standard donor hearts longer than traditional cold storage during transport.
Panelists voting in favor did so despite complaining of flimsy safety and effectiveness data in the PROCEED II[2], EXPAND[3], and EXPAND CAP[4] studies.
"While the data is certainly not robust, it seems to me it is safe and effective, particularly given the choice of not using a heart, and hopefully the final decision will be that the chosen donors[5] will be ...
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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