The FDA has cleared FAS INTERNATIONAL LTD.'s (Calgary, Alberta) endoluminal brush, which will be launched in the spring, the company announced Wednesday.
        The approval allows the brush to be used on authority of a physician to collect a biofilm or fibrin samples from the interior of an in-dwelling central venous catheter. The sample of the material then can be cultured for a microbacterial analysis, according to FAS.
        As earlier reported in Medical Industry Today, sales of the brush have been growing steadily in the United Kingdom, Austria and Australia since 1997. The brush can help hospitals minimize catheter replacement and antibiotic usage associated with infections in patients with an intravenous catheter.
        Such infections are potentially life threatening, and if the catheter is suspected as the source, it usually is removed. However, subsequent bacterial cultures show most of the removed catheters were sterile, according to a 1996 article in the British Medical Journal which assessed the brush's effectiveness. Researchers used the brush to obtain samples from the interior of catheters to determine whether infection-causing organisms were present.
        The two-year study found that using the brush could reduce the removal of sterile catheters wrongly suspected of harboring infection.
        In a statement, FAS International's chief executive officer Dr. Anthony C. Nicholls called the FDA approval "another major milestone in our corporate progress." He expects the U.S. launch increases the company's market by about $100 million.
       "We are now focusing on completing the necessary relabeling and packaging tasks in order to provide product for the U.S. launch in late spring," Nicholls stated. "We hope that the increasing European awareness of the FAS Endoluminal Brush as a device useful in the minimization of unnecessary catheter replacement and in the reduction of inappropriate antibiotic usage will be carried quickly to U.S. hospitals."
        FAS International, operating through its subsidiaries and with its main office in Sunbury, England, develops, manufactures and markets medical devices and diagnostic tests.