April 27, 2019

FDA Approves Device to Help Increase Access to More Lungs for Transplant

The US Food and Drug Administration (FDA) has approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can ventilate, oxygenate, and pump preservation solution through lungs that were initially thought to be unacceptable for transplant for up to 5 hours. This provides surgeons with an opportunity to reassess transplant suitability.

The Xvivo Perfusion System was originally granted marketing authorisation in 2014 under a humanitarian device exemption, a regulatory pathway that limits the device’s use to a maximum of 8,000 patients per year. Today’s approval through the FDA’s more stringent premarket approval pathway does not limit yearly patient use of the device, thereby allowing an increased number of lungs to be available for transplant and potentially increasing the number of patients who can benefit from this technology.

Lung transplantation remains the only known life-saving treatment for end-stage lung disease, but many patients die while waiting for suitable lungs to become available for transplant. On average, only 15% of lungs obtained from deceased donors are suitable for transplantation. This is because the physiological function of a large number of donor lungs is questionable.

“Sadly, too many patients on transplant lists die waiting for suitable lungs,” said Benjamin Fisher, PhD, FDA Center for Devices and Radiological Health, Rockville, Maryland. “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.”

The FDA evaluated data from a study involving 332 sets of donor lungs that were allocated into 3 groups: 1 group served as the control and were lungs initially deemed suitable for transplant that were provided to 116 recipients after standard preservation; 1 group were lungs initially deemed unsuitable for transplant and, after being perfused with the Xvivo Perfusion System, were implanted into 110 recipients; the third group were perfused with the Xvivo Perfusion System and were still deemed not suitable after the perfusion, and therefore were not implanted into patients.

The 1-year survival rate was 94% for the control group compared with 86.4% for the patients who received lungs that were deemed suitable for transplant after perfusion. The difference in rates was not deemed to be clinically significant.

The most common adverse events associated with the device include acute rejection, bronchial complications, respiratory failure, and infections.

The FDA granted premarket approval to Xvivo Perfusion Inc. Premarket approval is the most stringent type of device marketing application required by the FDA and is based on a determination by the FDA that the premarket approval pathway application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s).

SOURCE: US Food and Drug Administration
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