FDA Approves Device That Allows for Reassessment of Lung Transplant Suitability
MONDAY, April 29, 2019 -- The U.S. Food and Drug Administration announced the approval of a new device on Friday that aims to increase the number of lungs available for transplant.
The Xvivo Perfusion System with Steen Solution Perfusate, which received marketing authorization approval in 2014 under a humanitarian device exemption, temporarily perfuses preservation solution through lungs considered unacceptable for transplant. The new approval under the FDA premarket approval pathway removes limits on a patient's yearly use of the device. With the use of this device, marginal-quality lungs that failed to initially meet standard transplant criteria are ventilated, oxygenated, and perfused at standard body temperature for up to five hours. Surgeons can reassess suitability of the lungs for transplant and can therefore transplant some of the lungs initially considered unsuitable. The device includes a perfusion cart with mechanical and electrical components that ventilate, oxygenate, and perfuse the lungs with the preservation solution.
Approval was based on a study of 332 sets of donor lungs. The lungs were distributed into three groups: a control group of donor lungs initially considered suitable for transplant and implanted into 116 recipients after standard preservation; a group of lungs initially considered unsuitable for transplant and after perfusion with the Xvivo Perfusion System were implanted into 110 recipients; and a group of lungs still deemed unsuitable for transplant after perfusion with the Xvivo Perfusion System and not implanted. After one year, the survival rates were 94 percent in the control group and 86.4 percent in the patients who received the lungs perfused with the Xvivo Perfusion System -- a clinically insignificant difference, according to the FDA.
Commonly reported adverse reactions associated with the Xvivo Perfusion System included acute rejection, bronchial complications, respiratory failure, and infections.
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Posted: April 2019