The FDA advisory hearing for the Transmedics Organ Care System (OCS) resulted in a unanimous vote in favor of the OCS’s safety and efficacy numbers, although there will be a considerable post-approval study requirement. The company was able to overcome a number of problems with the pivotal study that might otherwise have tanked the application, such as the lack of blinding of transplant surgeons, which the FDA said could have biased the determination of whether a liver was acceptable for transplant.