FDA Approves Glue to Seal Air Leaks After Lung Surgery
WASHINGTON — Cancer patients who have tumors cut from their lungs frequently suffer air leaks that surgeons have trouble plugging. But doctors have found a possible solution: a glue-like sealant to patch leaky lungs.
The Food and Drug Administration approved FocalSeal on Tuesday. It’s a two-step process, where chemicals are squirted onto the leak and then “activated” with a beam of light to form a gelatin-like seal that moves as the lung breathes.
The hope is that by better sealing air leaks, lung cancer patients might be released from hospitals sooner, said Dr. Stephen Yang of Johns Hopkins University Hospital in Baltimore. Yang tested the sealant in a study sponsored by its manufacturer, Focal Inc.
He described air leaks as “the Achilles heel of lung surgery. Nothing has effectively minimized them, he said.
Stitching up delicate lung tissue after cancer surgery can seal the lung so it properly inflates again, but sometimes stitched incisions don’t seal well enough. Doctors have tried other surgical glues, but none would adhere to the moist, moving lung, Yang said.
If the air leak is bad enough, patients need tubes in their chests to pump out the air, which keeps them hospitalized longer.
In a study at four U.S. hospitals, 125 patients had air leaks treated with standard stitching plus FocalSeal while another 55 patients had air leaks treated with standard methods alone.
Adding FocalSeal helped 39% of hospital patients become free of air leaks by the time they were discharged, compared with only 11% of patients treated with standard methods.
The study did not prove that FocalSeal, which will cost patients about $500, truly decreased hospitalization time, cautioned the FDA’s Dr. Celia Witten.
And although cancer returned in about 10% of the FocalSeal-treated patients compared with about 7% in the others, the FDA did not consider the difference statistically significant.
“I don’t know that you can draw any conclusions that there’s a problem,” Witten said. Yang added that it’s possible patients with worse cancer were treated with FocalSeal.
To settle the issue, the FDA ordered the manufacturer to continue tracking the patients who tested FocalSeal to see whether cancer recurrence is a real problem.
FocalSeal is made partly of the same biodegradable materials used in stitches, so over time the body will absorb the lung patch.
Focal, Inc., based in Lexington, Mass., will begin selling the sealant immediately.
