FDA approves device to increase access to more lungs for transplant
The FDA has announced premarket approval of a new device that can temporarily ventilate, oxygenate and perfuse preservation solution through lungs that were initially thought to be unacceptable for transplant.
The Xvivo Perfusion System with Steen Solution Perfusate allows the transplant team to perform more careful assessment of lung function to better understand how the organs are working when they are perfused with a solution outside the body to better determine whether the lungs can then be viable for transplant, according to an FDA press release. The system consists of a perfusion cart with mechanical and electrical components that ventilate, oxygenate and perfuse the lungs with a lung-preservation solution. The system 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 5 hours. This provides an opportunity for surgeons to reassess transplant suitability, thus allowing them to transplant a certain percentage of lungs that were initially deemed to be unsuitable, according to the release
The Xvivo system was originally granted marketing authorization in 2014 under the FDA’s humanitarian device exemption (HDE), which limited use of the device to a maximum of 8,000 patients per year. The new approval, via the FDA’s PMA pathway, does not limit yearly use of the device, thereby allowing an increased number of lungs to be available for transplant, according to the release.
The new approval was based on data from a study that evaluated 332 sets of donor lungs that were allocated to three groups: a control group comprising lungs initially deemed suitable for transplant and were provided to 116 recipients after standard preservation; a group of lungs initially deemed unsuitable for transplant that were then implanted into 110 recipients after being perfused with the Xvivo Perfusion System; and a group of lungs that were still considered unsuitable after perfusion with the Xvivo Perfusion System and were not implanted into patients. In this study, the 1-year survival rate was 94% for the control group compared with 86.4% for the lung-perfusion patients. The difference in rates was not clinically significant.
Approximately 2,530 lung transplants were performed in 2018, according to statistics from the HHS. On average, it is estimated that just 15% of lungs obtained from deceased donors are suitable for transplantation, due to poor lung quality or possible injury of donor lungs or inadequate time to find a suitable donor-recipient match, according to the release.
“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,” Benjamin Fisher, PhD, director of the division of reproductive, gastro-renal and urological devices at the FDA’s Center for Devices and Radiological Health, stated in the release.
Disclosure: Fisher is an employee of the FDA.