Xvivo Perfusion System is an Ex Vivo Lung Perfusion (EVLP) platform for lung transplant got its approval from U.S. Food and Drug Administration.
The device is called Xvivo Perfusion System with Steen Solution Perfusate that can be used for temporarily ventilate, oxygenate, and pump through lungs.
The Xvivo Perfusion System was originally granted marketing authorization in 2014 under a humanitarian device exemption (HDE). And current approval by premarket approval (PMA) pathway allowing an increased number of lungs to be available for transplant and potentially increasing the number of patients who can benefit from this technology.
It works by allowing marginal quality lungs that initially failed to meet standard transplant criteria to be ventilated, oxygenated and perfused at a standard normal body temperature for up to five hours. This provides an opportunity for surgeons to reassess transplant suitability, allowing them to transplant a certain percentage of lungs. The device consists of a perfusion cart with mechanical and electrical components that ventilate, oxygenate and perfuse the lungs with a lung preservation solution.
“Sadly, too many patients on transplant lists die waiting for suitable lungs. Providing patients with access to safe medical devices that have the potential to be lifesaving remains a top FDA priority, and we support the development of innovative technologies that can increase the donor organ pool for transplant patients in need of suitable lungs,” said Benjamin Fisher, Ph.D., director of the Division of Reproductive, Gastro-renal, Urological Devices at the FDA’s Center for Devices and Radiological Health in a press release.