TransMedics' 'heart in a box' donor organ preservation system ... | 合法醫療器材資訊網
Some people wear their hearts on their sleeves, but TransMedics is all about its “heart in a box”—and now, so is an FDA advisory panel, which voted in favor of agency approval for the donor heart preservation technology.
The OCS Heart System essentially acts as a miniature ICU on wheels. Using warm perfusion and monitoring technology, the system keeps donor hearts at a metabolically active state equivalent to one inside the human body to ensure they stay viable for transplant as long as possible.
In a clinical trial[1] focusing on donor hearts that may not have been usable if preserved with typical cold storage techniques, more than 80% were successfully transplanted with the help of the OCS Heart System. Those transplants resulted in a 95% one-month survival rate, about equal to the national average for all heart transplants.
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TransMedics' 'heart in a box' donor organ preservation system ... | 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
Donor Heart Preserver Survives Review by FDA Advisors ... | 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 Announces Scheduling of OCS Heart FDA ... | 合法醫療器材資訊網
OCS Heart for HCP's | 合法醫療器材資訊網
TransMedics Announces Positive FDA Advisory ... | 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
Questions for the Advisory Committee meeting for the ... | 合法醫療器材資訊網
TransMedics Announces Temporary Postponement of OCS ... | 合法醫療器材資訊網
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