TransMedics Unveils CHOPS Device to Streamline Heart and Lung Transplant Trials
Event summary
- TransMedics introduced the Controlled Hypothermic Organ Preservation System (CHOPS) at the ISHLT 2026 Annual Meeting.
- CHOPS aims to facilitate enrollment in control arms of OCS ENHANCE Heart Part B and OCS DENOVO Lung clinical trials.
- FDA granted full approval for IDEs of Next-Generation OCS ENHANCE Heart (February 2026) and OCS DENOVO Lung (January 2026) trials.
- CHOPS will be regulated as a stand-alone device for controlled hypothermic preservation.
The big picture
TransMedics' introduction of CHOPS represents a strategic move to strengthen its position in the organ transplant therapy market. The device aims to improve the consistency and stability of organ preservation, addressing a critical need in the transplantation process. This development comes as the company continues to navigate regulatory approvals and clinical trial milestones, which are essential for expanding its product portfolio and market reach.
What we're watching
- Regulatory Approval
- Whether the FDA will approve the IDE amendment for CHOPS to serve as the control arm in the ENHANCE Heart Part B and DENOVO Lung trials.
- Market Expansion
- The pace at which TransMedics can expand its product offerings to include true controlled active cooling preservation devices.
- Clinical Trial Outcomes
- How the outcomes of the ENHANCE Heart Part B and DENOVO Lung trials will impact the adoption of OCS technology.
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