The FDA today granted premarket approval to Xvivo Perfusion for its Xvivo Perfusion system with Steen solution perfusate intended to temporarily ventilate, oxygenate and pump preservation solution through lungs intended for transplantation procedures.
The system is designed for use with lungs initially thought to be unacceptable for transplant, and allows a transplant team to perform a careful assessment of lung function to better understand how they work when they are perfused with a solution to assess their viability for transplantation, according to an FDA release.
The Xvivo system won initial approval through an FDA humanitarian device exemption in 2014, according to the release.
The FDA said that on average, only 15% of lungs obtained from deceased donors are suitable for transplantation due to the questionable physiological function of a large number of donor lungs due to poor lung quality or possible injury, or an inadequate amount of time to find a suitable donor-recipient match.
“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,” FDA CDRH Division of Reproductive, Gastro-renal, Urological Devices director Benjamin Fisher said in a press release.
The Xvivo system operates by allowing marginal quality lungs which initially failed to meet standard transplant criteria to be ventilated, oxygenated and perfused at a standard normal body temperature for up to five hours. Surgeons can then reassess transplant suitability, which allows for the transplantation of a certain percentage of lungs initially deemed to be unsuitable.
The system consists of a perfusion cart with mechanical and electrical components to ventilate, oxygenate and perfuse the lungs with a lung preservation solution.
Approval of the device came from data from a study involving 332 sets of donor lungs. Lungs in the study were split into three groups: a control group of lungs deemed suitable for transplant provided to 116 individuals after standard preservation; a group of lungs initially deemed unsuitable for transplant that after perfusion with the system were implanted into 110 patients; and a third group that were perfused by the system and still deemed not suitable for implant.
Data indicated a one-year survival rate of 94% in the control group compared to 86.4% for the lung perfusion patients, with rate differences deemed to be not clinically significant, the FDA said.
The most common adverse events associated with the device included acute rejection, bronchial complications, respiratory failure and infections, according to the release.
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