FDA approves lung preservation machine (Update)

Federal health regulators have approved a novel device that can preserve donated lungs outside the body for possible transplantation into critically ill patients.

The Food and Drug Administration said Tuesday that the approval of the XVIVO Perfusion System could lead to more successful transplants of lungs for people with cystic fibrosis and other deadly respiratory diseases.

The device consists of a bubble-like chamber where the lungs are stored and connected to a series of pumps and filters that provide oxygen and a sterile cleansing solution. Lungs can be kept in the machine for four hours as doctors evaluate their suitability for transplant.

Only about one in five lungs currently donated meet the medical criteria for transplantation. By giving doctors more time to examine the organs, FDA officials say more lungs may ultimately be transplanted.

In 2012, 1,754 lung transplants were performed in the U.S. with 1,616 patients still on the national waiting list. Lung transplantation is often the only treatment for patients with end-stage lung diseases, including chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis.

The device is made by Englewood, Colorado-based XVIVO Perfusion Inc.

The FDA approved the new device based on two studies of patients who received non-ideal lungs preserved with the XVIVO Perfusion System or ideal lungs preserved with conventional cold storage techniques. The studies showed that patients from both groups had similar survival rates up to a year after undergoing transplant.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Many more lungs suitable for transplantation

Jun 30, 2011

Four patients now have new lungs thanks to a purpose-built machine used for the first time worldwide by Sahlgrenska University Hospital. Acquired for research at the Sahlgrenska Academy, University of Gothenburg, Sweden, ...

Recommended for you

New medical device to make the mines safer

Nov 21, 2014

Dehydration can be a serious health issue for Australia's mining industry, but a new product to be developed with input from Flinders University's Medical Device Partnering Program (MDPP) is set to more effectively ...

US family gets $6.75 million in Botox case

Nov 20, 2014

A New York couple who said Botox treatment of their son's cerebral palsy left him with life-threatening complications and sued its manufacturer won a $6.75 million verdict from a federal jury on Thursday.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.