Transmedics’ OCS Heart System Gets Expanded FDA Premarket Approval

The FDA has granted expanded premarket approval to Transmedics’ OCS Heart System.

The organ care system was previously approved for preservation of donation-after-brain-death donor hearts that could not be preserved using standard cold storage. The expanded approval is for preservation of donation-after-circulatory-death donor hearts, when the heart is recovered for use after all circulatory and respiratory functions of the donor have stopped.

The OCS Heart System features a portable enclosure that warms the donor heart and supplies it with oxygen and nutrients. It also measures and displays metrics, such as temperature and pressure.

In a clinical study, 94 out of 100 people who received a donation-after-circulatory-death heart preserved using the OCS Heart System were alive six months after transplant, compared with 91 out of 100 recipients using the standard cold storage method, the company said.