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      "text": "The surgeon stated that the OCS Liver device “is approved for standard anatomy” only – when “the liver has abnormal anatomy, like excessive right hepatic artery...this is off-label.”",
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      "text": "FDA PMA Approval Order Statement, Summary of Safety and Effectiveness Data – Sept 28, 2021",
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      "text": "“40-50% at least” of livers beyond labeled age; also used off-label for abnormal anatomy; 1/3 of livers abnormal",
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      "text": "The surgeon stated that off-label use for organs above the indicated donor age was rampant – “40-50% at least...they will use the device off-label.”",
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      "text": "“40-50% at least...they will use the device off-label.” — Transplant procurement surgeon previously working with TransMedics",
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      "text": "Source: Scorpion Capital consultation calls with experts; https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200031B.pdf",
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