案例库 · 产品与设计 · 产品决策 · 2003–2018
这条还没译成中文，下面是英文原文。
TransMedics' OCS keeps donor hearts beating in transit and revives 'unusable' organs
Instead of packing a donor heart on ice, the OCS perfuses it warm and beating in transit; 81% of OCS hearts other centers had rejected were transplanted.
TransMedics
那一手
Organ transport traditionally meant cold static storage: the heart is flushed, packed on ice and raced to the recipient, and beyond a few hours of ischemic time the damage makes transplantation unsafe. Distance, not scarcity alone, decides who receives an organ.
TransMedics built the Organ Care System, a portable console that perfuses the donor heart warm and beating during transport. PROCEED II, a randomized trial of 130 patients, found 30-day patient and graft survival of 94 percent with OCS versus 97 percent with cold storage — similar outcomes, with the added ability to assess the organ before implant.
In EXPAND trials, the OCS achieved an 81 percent utilization rate for donor hearts that other centers had rejected — on average 66 times — and an 87 percent rate for lungs; by its 2019 S-1, the OCS had been used in over 1,200 transplants, and the FDA's first PMA for the platform (lung) came in March 2018.
为什么管用
- Warm beating preservation avoids the damage of cold ischemic storage.
- Longer viable transport time widens the donor pool geographically.
- Live assessment lets teams accept or reject an organ on evidence.
- Recovering 'unusable' organs multiplied the addressable market.
可以搬走什么
If the product degrades in transit, don't just insulate the box — keep the product in its working state: preserving function during logistics beats preserving an idle state.
后来呢
TransMedics expanded OCS to lungs and liver, later won FDA approval for heart and DCD hearts, and its National OCS Program pushed transplant procurement from cold storage toward perfused, monitored transport.
资料来源
- Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II) — Lancet, 2015
- TransMedics Group — Form S-1 (April 2019)
- TransMedics — OCS Heart: the only FDA-approved warm perfusion system
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