TransMedics Unveils CHOPS to Back OCS ENHANCE Heart and DENOVO Lung Trials
TransMedics unveiled CHOPS, a controlled cooling system, to serve as control arms in its OCS ENHANCE Heart Part B and OCS DENOVO Lung trials. The FDA granted IDEs for OCS ENHANCE Heart in February 2026 and OCS DENOVO Lung in January 2026, with an amendment pending to add CHOPS.
1. CHOPS Device Introduction
TransMedics introduced the Controlled Hypothermic Organ Preservation System (CHOPS) as a true active cooling device designed to maintain donor organs at precise temperature ranges. Unlike phase changing materials, CHOPS delivers consistent, adjustable cold storage to support robust control arms in key heart and lung trials.
2. Regulatory Milestones
The FDA granted IDE clearance for the Next-Generation OCS ENHANCE Heart trial in February 2026 and for the Next-Generation OCS DENOVO Lung trial in January 2026. TransMedics plans to submit an IDE amendment to integrate CHOPS as the designated control device for both Part B of ENHANCE Heart and the DENOVO Lung study.
3. Clinical Trial Implications
Part B of the ENHANCE Heart trial will compare OCS Heart perfusion against static cold storage in donation after brain death cases. The OCS DENOVO Lung trial will assess OCS Lung perfusion versus static methods in both donation after brain death and circulatory death scenarios, with CHOPS supporting direct comparisons.
4. Potential Product Expansion
Pending FDA approval, CHOPS would broaden TransMedics’ product portfolio to include controlled active cooling preservation devices. This expansion aims to capture a wider segment of the heart and lung transplant market, underpinned by prospective level 1 clinical evidence.