TransMedics Group (NASDAQ:TMDX) reached a pivotal regulatory milestone Monday, receiving full and unconditional approval from the FDA to launch its next-generation OCS ENHANCE Heart trial.
The Andover, Massachusetts-based medical technology leader, known for its "Heart-in-a-Box" technology, confirmed that the Investigational Device Exemption (IDE) approval will allow it to proceed with the largest heart preservation trial ever conducted.
With a planned enrollment exceeding 650 patients, the ENHANCE trial aims to shift the global standard of care from traditional static cold storage toward the company’s warm, oxygenated perfusion system.
The two-part study is designed to prove that the Gen 2 OCS Heart platform is more than just a transportation tool.
Part A will focus on supporting hearts during prolonged perfusion—allowing organs to travel much further distances—while Part B will utilize a randomized superiority comparison against standard cold storage.
By targeting "Donation after Brain Death" (DBD) hearts that are currently transplanted within the conventional four-hour window, TransMedics hopes to demonstrate that its technology can actively enhance and improve cardiac function before the organ ever reaches the recipient.