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  "documentTitle": "TransMedics (TMDX)",
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  "authorName": "Kir Kahlon",
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  "presentationDate": "2024-01-14 00:00:00",
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  "notes": "This is a regulatory petition document page. It outlines specific allegations of off-label use ('back to base') and device failure, followed by a formal list of requested regulatory actions.",
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      "text": "Ex-employees, surgeons, and organ procurement organizations indicated to us that: a) TransMedics OCS Liver devices are plagued by failures leading to the loss of a significant percentage of organs; b) that livers in particular are prone to becoming necrotic...",
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      "text": "Ex-employees of TransMedics estimate that 1/3 of livers placed on the pump are specifically contraindicated. Section 3 of the label (“Contraindications”) states that OCS Livers should not be used for split livers...",
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      "text": "b. Request data from TransMedics for each liver perfused on its device. TransMedics and each of the 57 Organ Procurement Organizations in the United States, we believe, maintain information for each organ...",
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      "text": "We note that normothermic perfusion-induced liver necrosis is a known risk of the technology, per the clinical literature, as cited in our report.",
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      "text": "Transplant centers are increasingly using OCS Liver off-label as “back to base,” meaning that livers are retrieved via static cold storage and then placed on the warm perfusion device back at the hospital...",
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      "text": "a. Convene an Ad Comm to discuss the issues raised in the attached report regarding off-label usage and device failures, and to help guide the agency’s next steps...",
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      "text": "2. Re-evaluate the safety and efficacy of the device in light of its actual usage, while current usage is suspended.",
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      "text": "1. Suspend FDA Pre-Market Approval of TransMedics OCS devices, the OCS Liver device in particular. The rampant off-label usage indicates that the device is not being used in the manner for which it was intended...",
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      "text": "This petition requests that the FDA take the following actions:",
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      "text": "of transplant failure at levels >20%; and that livers >30% are simply discarded. One study shows 2-3 fold higher levels of death in patients receiving fatty livers.",
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      "text": "Device failures/necrotic livers (please refer to p326-342, Exhibit A)",
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