USFDA approves perfusion device for lung transplantsJuly 4, 2019
The Xvivo Perfusion System works by allowing marginal quality lungs that initially failed to meet standard transplantation models to be ventilated, oxygenated and perfused at standard normal body temperature for up to five hours.
The USFDA Xvivo Perfusion System with Steen Solution Perfusate, that can temporarily ventilate, oxygenate, and pump preservation solution through lungs that were initially thought to be unacceptable for transplant.
The device allows a more careful assessment of lung function when they are perfused with a solution outside the body to better determine whether the lungs can then be viable for transplant.
The device works by allowing marginal quality lungs that initially failed to meet standard transplant criteria to be ventilated, oxygenated and perfused at standard normal body temperature for up to five hours.
The device consists of a perfusion cart with mechanical and electrical components that ventilate, oxygenate and perfuse the lungs with a lung preservation solution.
The FDA evaluated data from a study involving 332 sets of donor lungs that were allocated into three groups for the approval.
The Xvivo Perfusion System was originally granted marketing authorization in 2014 under a humanitarian device exemption (HDE), a regulatory pathway that limits the device’s use to a maximum of 8,000 patients per year.