TransMedics Group secured conditional Investigational Device Exemption approval from the U.S. Food and Drug Administration, clearing the company to launch its next-generation OCS ENHANCE Heart trial. The study will evaluate a new version of the company’s Organ Care System, which keeps donor hearts functioning outside the body prior to transplantation. The two-part trial is expected to enroll more than 650 patients, making it the largest heart-preservation study to date. Part A will assess the device’s ability to support prolonged perfusion, while Part B will test whether OCS perfusion outperforms conventional static cold storage for hearts from donation-after-brain-death donors that are currently ineligible for OCS use. TransMedics plans to open enrollment in the fourth quarter of 2025. Management said the heart study, together with a recently initiated 450-plus-patient DeNovo Lung trial, could drive wider adoption of the OCS platform in coming years. Investors welcomed the update; TransMedics shares rose roughly 5.5 percent in intraday trading following the announcement.