TransMedics Group, Inc., a medical technology company focused on improving outcomes for patients with end-stage heart, lung, and liver failure, announced that the U.S. Food and Drug Administration has granted full and unconditional approval of its Investigational Device Exemption for the Next-Generation OCS ENHANCE Heart trial. This follows the full IDE approval for the company’s DENOVO Lung trial in January 2026 and the conditional IDE approval for ENHANCE Heart granted in August 2025.
Health Technology Insights: MHK Launches SmartProminence AI Solutions
The ENHANCE trial is designed as a two-part study. Part A will evaluate the ability of the OCS Heart System to support prolonged heart perfusion. Part B is focused on demonstrating the potential superiority of OCS Heart perfusion compared with traditional static cold storage for donor hearts from brain death cases. Part B is also expected to provide evidence supporting the expansion of clinical indications to include standard criteria donor hearts that are typically transplanted within four hours of preservation. Across both parts of the study, TransMedics anticipates enrolling more than 650 patients, which the company believes will make this the largest heart preservation trial ever conducted globally.
Health Technology Insights: Artera Secures $65Million Growth Investment and Reaches $100Million CARR
Waleed Hassanein, MD, President and Chief Executive Officer of TransMedics, stated that the company is now focused on trial execution and patient enrollment. He explained that the ENHANCE trial is designed to provide the highest level of clinical evidence for the Gen 2 OCS Heart platform, aiming to show that it is more than a preservation device and can actively enhance cardiac function and metabolic conditions during perfusion. Dr. Hassanein emphasized that this study represents the first randomized, controlled, and blinded clinical trial in donor heart preservation intended to demonstrate that OCS Heart perfusion is superior to cold static storage for transplantation. He added that the results from the ENHANCE and DENOVO trials are expected to be important drivers for adoption of OCS technology for heart and lung transplantation in 2026 and beyond.
Health Technology Insights: First Stop Health Joins ParetoHealth Network
To participate in our interviews, please write to our HealthTech Media Room at info@intentamplify.com
