FDA Clears LivaNova’s Modification to Heater-Cooler Device

The FDA cleared a modification for LivaNova’s 3T Heater-Cooler device, allowing the installation of a 3T Aerosol Collection Set.

LivaNova’s 3T heating and cooling device is designed to meet the temperature needs of patients undergoing cardiac surgery. It includes separate settings for warm cardioplegia, cold cardioplegia and patient temperature.

The cleared use helps to reduce the risk of aerosol dispersion in hospital operating rooms when the device is used properly.