Le Lézard
Classified in: Health, Science and technology
Subject: FDA

FDA approves device to help increase access to more lungs for transplant


SILVER SPRING, Md., April 26, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration today approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through lungs that were initially thought to be unacceptable for transplant. The device allows the transplant team to perform a more careful assessment of lung function to get a better sense of 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.

U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)

The Xvivo Perfusion System was originally granted marketing authorization in 2014 under a humanitarian device exemption (HDE), 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 (PMA) 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 percent 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 due to, for example, poor lung quality or possible injury, or there is inadequate time to find a suitable donor-recipient match. Approximately 2,530 lung transplants were performed last year, according to the U.S. Department of Health and Human Services.

"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," said Benjamin Fisher, Ph.D., director of the Division of Reproductive, Gastro-renal, Urological Devices at the FDA's Center for Devices and Radiological Health.

The Xvivo Perfusion 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 five hours. This provides an opportunity for surgeons to reassess transplant suitability, allowing them to transplant a certain percentage of lungs that were initially deemed to be unsuitable. The device consists of a perfusion cart with mechanical and electrical components that ventilate, oxygenate and perfuse the lungs with a lung preservation solution.

The FDA evaluated data from a study involving 332 sets of donor lungs that were allocated into three groups: one group served as the control and were lungs initially deemed suitable for transplant that were provided to 116 recipients after standard preservation; one 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 one-year survival rate was 94 percent for the control group compared to 86.4 percent for the lung perfusion patients. The difference in rates was not deemed to be clinically significant.

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

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

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Alison Hunt, 240-402-0764 alison.hunt@fda.hhs.gov 
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration


These press releases may also interest you

at 11:51
During the celebration of the 31st year of Country Cares for St. Jude Kids, St. Jude Children's Research Hospital® announced seven-time Grammy winning trio Lady Antebellum as the 2020 recipients of the prestigious Randy Owen Angels Among Us Award....

at 11:05
The 17th Guignolée Dr Julien Fundraiser ended this week with a total of $1,602,357 raised in support of the Fondation's three centres of expertise (the Centre Hochelaga, the Garage à musique and the Centre Côte-des-Neiges). This amount represents...

at 11:00
Local, regional and national leaders of the United Church of Christ announced Jan. 18 that church donations have wiped out $12.9 million in medical debt for 11,108 households in and around St. Louis. Families are now receiving letters telling them...

at 10:00
A December 24 article in The Salt Lake Tribune reports on the growing acceptance of surrogacy and the safeguards that are increasingly protecting everyone involved in the process of bringing a new child into the world. Naturally, the parental journey...

at 10:00
Healor Primary Care announces the arrival of affordable medical care with economic wellness plans and a wholesale drug pharmacy. The unique concept offers access to complete medical services for everyone and extends a welcome to anyone who cannot...

at 09:00
Merck Animal Health, a division of Merck & Co., Inc., Kenilworth, N.J., USA , today announced the results of a comprehensive study of wellbeing and mental health among U.S. veterinarians, which are critical issues facing the veterinary profession....



News published on 26 april 2019 at 16:25 and distributed by: