FDA Approves Perfusion Device for Lung Transplants

APRIL 26, 2019
Kevin Kunzmann
FDAThe US Food and Drug Administration (FDA) has approved a device designed to temporarily ventilate, oxygenate, and pump preservation solution through lungs initially thought unacceptable for transplant.

The Xvivo Perfusion System with Steen Solution Perfusate was approved through an unlimited yearly patient-use permit that will potentially increase the rate of transplantable lungs over time. The indication negates the annual 8000-patient limit previously set by the granted marketing authorization in 2014.

As the only known life-saving treatment for end-stage lung disease, lung transplantation is only a suitable procedure for about 15% of the lungs collected from deceased donors. Donated lungs are frequently of poor quality or susceptible to injury. Despite this, approximately 2530 lung transplants were performed in the US last year.

The approved system allows marginal-quality lungs to become ventilated, oxygenated, and perfused at a standard body temperature for up to 5 hours. In this time frame, surgeons can reassess patient transplant suitability and transplant an increased rate of lungs initially deemed unsuitable.

Its approval was based on a study involving 332 donor lung sets allocated into 3 groups: those initially deemed suitable (n= 116); those initially deemed unsuitable, then perfused by the device and implanted (n= 110); and control (n= 100).

The survival rate at 1 year was 86.4% for lung perfusion patients, and 94% for control patients—a clinically insignificant different. Common adverse events associated with the device included acute rejection, bronchial complications, respiratory failure, and infections.

"Sadly, too many patients on transplant lists die waiting for suitable lungs,” Benjamin Fisher, PhD, director of the Division of Reproductive, Gastro-renal, Urological Devices at the FDA's Center for Devices and Radiological Health, said in a statement. “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.”

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