[MOL] FDA approves lung sealant..... [01329] Medicine On Line

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[MOL] FDA approves lung sealant.....


FDA Approves Lung Sealant

Associated Press
May 31, 2000

WASHINGTON (AP) - Cancer patients who have tumors cut from their lungs frequently suffer air leaks that surgeons have trouble plugging, but doctors now are getting a possible solution: A glue-like sealant to patch leaky lungs.

The Food and Drug Administration approved the 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-looking seal that moves as the lung breathes.

The hope is that by better sealing up air leaks, lung cancer patients might get out of the hospital faster, said Dr. Stephen Yang of Johns Hopkins University Hospital in Baltimore, who tested the sealant in a study sponsored by manufacturer Focal Inc.

"Air leaks is the Achilles heel of lung surgery," Yang explained. "There's really been nothing effective to minimize" them.

Stitching up delicate lung tissue after cancer surgery can seal the lung so it properly inflates again. But sometimes stitches 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 percent of patients be free of air leaks at hospital discharge, while only 11 percent of patients treated with standard methods were free of the problem.

The study did not prove that FocalSeal treatment, which will cost patients about $500, truly decreased hospitalization time, cautioned the FDA's Dr. Celia Witten.

And there is a concern: Thirteen of the 125 FocalSeal-treated patients had their cancer return during the study, as opposed to only four of the 55 patients not treated with FocalSeal.

That difference is not statistically significant so, following the advice of the government's scientific advisers, the FDA decided the concern wasn't enough to stop FocalSeal's sale.

"I don't know that you can draw any conclusions that there's a problem," Witten said. Yang added that it's possible the explanation is patients with worse cancer wound up getting FocalSeal. To settle the issue, the FDA ordered the manufacturer to continue tracking the patients who tested FocalSeal to see if cancer recurrence is a real problem or not.

FocalSeal is made partly of the same materials as biodegradable stitches, so over time the body will absorb the lung patch.

Lexington, Mass.-based Focal Inc. will begin selling the sealant immediately.

Copyright 2000 The Associated Press. All rights reserved.