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A device that preserves less-than-ideal donor lungs until they are cleared for transplantation has been approved, the Food and Drug Administration announced on Aug. 12.
The ex vivo perfusion device preserves donated lungs that initially do not meet all the criteria for a transplantable lung. The device does this by warming the donor lungs to "near normal body temperature," continuously flushing the lung with a sterile solution, and ventilating them, "which oxygenates the cells and makes it possible for the transplant team to examine the lung’s’ airways with a bronchoscope," according to the FDA statement.
The lungs can remain in the machine for up to 4 hours, providing time for the transplant team to evaluate the lungs to determine if they meet the criteria; donor lungs that meet the criteria are then transplanted into a patient.
The device, the XVIVO Perfusion System (XPS) with STEEN Solution, is manufactured by XVIVO Perfusion.
"With this approval, there may be more lungs available for transplant, which could allow more people with end-stage lung disease who have exhausted all other treatment options to be able to receive a lung transplant," Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, Silver Spring, Md., said in the statement.
About 1 in 5 donor lungs meets the standard transplantation criteria. In the United States, 1,754 lung transplants were performed in 2012 and 1,616 potential recipients were on the lung transplant waiting list at the end of 2012, according to the FDA.
In two studies, outcomes for lung-transplant recipients were similar among those who received a donor lung preserved with the device and those who received donor lungs that were considered ideal and were preserved in cold storage.
"Both trials showed that recipients of the ideal and non-ideal lungs had similar survival rates up to 12 months after transplant and similar rates of organ rejection," the FDA statement said.
The manufacturer is required to conduct a long-term study of the effects of the device as a condition of approval.
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Dr. Jennifer Cox, FCCP, comments: This is exciting news given the shortage of available lungs that meet the current transplant criteria. Early studies showing similar 12-month survival rates and rates of organ rejection are encouraging. I would like to know if there were similar hospital lengths of stay and if there was a difference in post operative complications. Also, how significant will the financial impact be using the device. I look forward to the results of long- term studies. Hopefully this will be a viable option for our patients.
Dr. Jennifer D. Cox, FCCP, is an Assistant Professor of Pulmonary and Critical Care Medicine and clerkship director for the fourth-year medical student Critical Care Selective, Morsani College of Medicine, University of South Florida, in Tampa, Florida.
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Dr. Jennifer Cox, FCCP, comments: This is exciting news given the shortage of available lungs that meet the current transplant criteria. Early studies showing similar 12-month survival rates and rates of organ rejection are encouraging. I would like to know if there were similar hospital lengths of stay and if there was a difference in post operative complications. Also, how significant will the financial impact be using the device. I look forward to the results of long- term studies. Hopefully this will be a viable option for our patients.
Dr. Jennifer D. Cox, FCCP, is an Assistant Professor of Pulmonary and Critical Care Medicine and clerkship director for the fourth-year medical student Critical Care Selective, Morsani College of Medicine, University of South Florida, in Tampa, Florida.
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Dr. Jennifer Cox, FCCP, comments: This is exciting news given the shortage of available lungs that meet the current transplant criteria. Early studies showing similar 12-month survival rates and rates of organ rejection are encouraging. I would like to know if there were similar hospital lengths of stay and if there was a difference in post operative complications. Also, how significant will the financial impact be using the device. I look forward to the results of long- term studies. Hopefully this will be a viable option for our patients.
Dr. Jennifer D. Cox, FCCP, is an Assistant Professor of Pulmonary and Critical Care Medicine and clerkship director for the fourth-year medical student Critical Care Selective, Morsani College of Medicine, University of South Florida, in Tampa, Florida.
A device that preserves less-than-ideal donor lungs until they are cleared for transplantation has been approved, the Food and Drug Administration announced on Aug. 12.
The ex vivo perfusion device preserves donated lungs that initially do not meet all the criteria for a transplantable lung. The device does this by warming the donor lungs to "near normal body temperature," continuously flushing the lung with a sterile solution, and ventilating them, "which oxygenates the cells and makes it possible for the transplant team to examine the lung’s’ airways with a bronchoscope," according to the FDA statement.
The lungs can remain in the machine for up to 4 hours, providing time for the transplant team to evaluate the lungs to determine if they meet the criteria; donor lungs that meet the criteria are then transplanted into a patient.
The device, the XVIVO Perfusion System (XPS) with STEEN Solution, is manufactured by XVIVO Perfusion.
"With this approval, there may be more lungs available for transplant, which could allow more people with end-stage lung disease who have exhausted all other treatment options to be able to receive a lung transplant," Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, Silver Spring, Md., said in the statement.
About 1 in 5 donor lungs meets the standard transplantation criteria. In the United States, 1,754 lung transplants were performed in 2012 and 1,616 potential recipients were on the lung transplant waiting list at the end of 2012, according to the FDA.
In two studies, outcomes for lung-transplant recipients were similar among those who received a donor lung preserved with the device and those who received donor lungs that were considered ideal and were preserved in cold storage.
"Both trials showed that recipients of the ideal and non-ideal lungs had similar survival rates up to 12 months after transplant and similar rates of organ rejection," the FDA statement said.
The manufacturer is required to conduct a long-term study of the effects of the device as a condition of approval.
A device that preserves less-than-ideal donor lungs until they are cleared for transplantation has been approved, the Food and Drug Administration announced on Aug. 12.
The ex vivo perfusion device preserves donated lungs that initially do not meet all the criteria for a transplantable lung. The device does this by warming the donor lungs to "near normal body temperature," continuously flushing the lung with a sterile solution, and ventilating them, "which oxygenates the cells and makes it possible for the transplant team to examine the lung’s’ airways with a bronchoscope," according to the FDA statement.
The lungs can remain in the machine for up to 4 hours, providing time for the transplant team to evaluate the lungs to determine if they meet the criteria; donor lungs that meet the criteria are then transplanted into a patient.
The device, the XVIVO Perfusion System (XPS) with STEEN Solution, is manufactured by XVIVO Perfusion.
"With this approval, there may be more lungs available for transplant, which could allow more people with end-stage lung disease who have exhausted all other treatment options to be able to receive a lung transplant," Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, Silver Spring, Md., said in the statement.
About 1 in 5 donor lungs meets the standard transplantation criteria. In the United States, 1,754 lung transplants were performed in 2012 and 1,616 potential recipients were on the lung transplant waiting list at the end of 2012, according to the FDA.
In two studies, outcomes for lung-transplant recipients were similar among those who received a donor lung preserved with the device and those who received donor lungs that were considered ideal and were preserved in cold storage.
"Both trials showed that recipients of the ideal and non-ideal lungs had similar survival rates up to 12 months after transplant and similar rates of organ rejection," the FDA statement said.
The manufacturer is required to conduct a long-term study of the effects of the device as a condition of approval.
