The FDA granted conditional approval of the company’s investigational device exemption (IDE). It allows the Andover, Massachusetts-based company to proceed with the initiation of its next-generation OCS ENHANCE trial.

ENHANCE, a two-part clinical trial, evaluates the system’s support for prolonged heart perfusion. It then aims to demonstrate the superiority of the OCS Heart perfusion in donation after brain death (DBD) cases. The study compares this to DBD cases using static cold storage methods.

TransMedics says the second part aims to support the potential expansion of its clinical indications to include DBD hearts not currently eligible for OCS perfusion and preservation. The company expects the trial, across both parts, to exceed 650 patients. It says this would mark the world’s largest heart preservation for transplant trial ever.