The FDA today granted premarket approval to Xvivo Perfusion for its Xvivo Perfusion system with Steen solution perfusate intended to temporarily ventilate, oxygenate and pump preservation solution through lungs intended for transplantation procedures. The system is designed for use with lungs initially thought to be unacceptable for transplant, and allows a transplant team to perform […]
(Reuters) – A machine that ‘reconditions’ a donor’s lungs outside the body before being transplanted into a recipient is undergoing tests in the United States in the hope that it can radically improve survival rates for people with chronic respiratory diseases. The XPS, manufactured by Swedish company XVIVO Perfusion , is in clinical trials at […]
The FDA granted Humanitarian Use Device approval for Sweden-based XVIVO Perfusion for its XPS tissue transport system for preserving donor lungs.
Sweden-based XVIVO Perfusion landed a date with the FDA to review Humanitarian Device Exemption for its XVIVO Perfusion System for preserving donor lungs.
XVIVO will meet on March 20 with the FDA’s Gastroenterology & Urology Devices Panel to review data on the device, which provides continuous perfusion of otherwise unacceptable lung tissue, allowing clinicians to reevaluate the organs for transplantation.