The FDA has approved a new type of surgical sealant for use in lungs to seal air leaks following
removal of cancerous lung tumors.
The product was given expedited review by the FDA because of its potential benefit in reducing the
number of patients who experience such air leaks.
The new sealant, which is "painted" on the lung and activated by light, is made by Focal Inc.,
Lexington, Mass. The product forms a sealant via chemical and photochemical polymerization processes.
Currently, air leaks are closed with standard techniques such as suturing, stapling or, in some patients,
leaving the air leaks alone.
The new FocalSeal-L Surgical Sealant is intended to be used after these standard tissue closure
FDA approval was based on a review of clinical studies of safety and effectiveness conducted by the
manufacturer and on the recommendation of the General and Plastic Surgery Devices Panel of FDA's
Medical Devices Advisory Committee, which evaluated the product in early May.
The primary study involved 180 patients at four medical centers in the United States. Most of the
patients were being surgically treated for lung cancer. In 125 of the patients, air leaks were treated with a
combination of standard techniques and Focal Seal; in 55 patients, air leaks were treated with standard
The studies showed that 39 percent of patients treated with Focal Seal and standard techniques were
air leak-free through hospital discharge compared to 11 percent of patients treated with standard techniques
Side effects were similar in both groups, but there was a higher incidence of infection in patients
treated with FocalSeal (7.2% vs. 3.6%).
As a condition of approval, Focal Inc. will continue to follow patients in the study for five years to see
if there is an impact on cancer progression.