Steen Solution Perfusate to heSwedish medical technology firm Xvivo Perfusion has received the US Food and Drug Administration (FDA) approval for the use of its Xvivo Perfusion System with lp in lung transplant procedure.
The device is meant to temporarily ventilate, oxygenate, and pump or perfuse preservation solution through lungs that were believed to be unacceptable for transplant.
Pumping the lungs with a solution outside the human body enables a better evaluation of lung function. This helps surgeons to then decide if the lungs are viable for transplant.
Xvivo Perfusion System, which comprises a perfusion cart with mechanical and electrical components, is expected to improve access to more lungs for transplant.
FDA Division of Reproductive, Gastro-renal, Urological Devices director Benjamin Fisher said: “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.”
The agency’s decision was based on findings from a study that evaluated 332 sets of donor lungs assigned into three groups.
The first control group had lungs that were initially deemed suitable for transplant and were provided to 116 recipients after standard preservation.
The second group involved lungs deemed unsuitable for transplant and after being perfused with the Xvivo Perfusion System implanted into 110 recipients, while the third group were perfused with the device and were still deemed unsuitable, and not implanted.
In the control group, the one-year survival rate was 94% compared to 86.4% for the lung perfusion patients. This difference was not considered as clinically significant.
The Xvivo Perfusion System previously secured the FDA marketing authorisation in 2014 as part the humanitarian device exemption (HDE) regulatory pathway that limits its use to a maximum of 8,000 patients per year.
This latest premarket approval lifts the limit on yearly patient use.