TransMedics approved by FDA for Next-Generation OCS Heart Trial

TransMedics (TMDX) Group announced that the U.S. FDA has granted conditional approval of its Investigational Device Exemption, allowing the company to proceed with the initiation of its Next-Generation OCS ENHANCE Heart trial. The ENHANCE trial is a two-part clinical trial. Part A is designed to support prolonged heart perfusion using OCS(TM) Heart System. Part B is intended to demonstrate the superiority of OCS Heart perfusion in donation after brain death cases when compared to DBD cases using static cold storage methods. Part B is intended to support the potential expansion of OCS Heart clinical indications to include DBD hearts that are not currently eligible for OCS perfusion and preservation. The trial’s total sample size, across both Part A and Part B, is expected to exceed 650 patients. TransMedics believes this would constitute the largest heart preservation for transplant trial ever, worldwide.