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JAMA. 2000;284:685.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has approved FocalSeal-L (Focal Inc, Lexington, Mass) for use in lungs as an adjunct to standard closure of pleural air leaks incurred during elective pulmonary resection, such as the removal of cancerous lung tumors.

The new product, which received expedited review by the FDA, consists of synthetic absorbable sealant and primer solutions that are applied to the target tissue site as liquids. Upon exposure to blue-green light, the primer and sealant solutions polymerize to form a cross-linked, clear, flexible, adherent hydrogel network.

The sealant was approved on the basis of two open label, prospective, randomized, multicenter studies comparing standard tissue closure techniques such as stapling or suturing with standard closure techniques plus the sealant.

In the primary study at four medical centers in the United States, 125 patients were treated with a combination of standard closure techniques and the sealant. In the control group of 55 patients, air . . . [Full Text of this Article]

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ABSTRACT