Bridge to Life’s Perfusion System Designated a Breakthrough Device by the FDA

Northbrook, Ill.-based Bridge to Life’s LifeCradle heart preservation transport system has been designated a Breakthrough Device by the FDA.

The LifeCradle system preserves donor hearts using perfusion and monitors them from the time of organ procurement until transplantation into the recipient. The device delivers an oxygenated perfusion solution that requires no blood or blood products.

The Breakthrough Device designation means that the FDA will expedite its review because of the device’s potential to aid in the treatment or diagnosis of a life-threatening or debilitating disease or condition.