FDA clears silver-coated breathing tube for marketing
9 Novembre 2007
The U.S. Food and Drug Administration today announced that it has cleared for marketing a breathing tube coated with a thin layer of silver. The coating, a material known to have antimicrobial
properties, reduces the risk that patients on ventilators will acquire pneumonia while in the hospital.
The Agento endotracheal tube, manufactured by C.R. Bard Inc., is intended for patients who must rely on a ventilator to breathe for 24 hours or more.
Patients requiring such a breathing support system are at risk of exposure to hospital-acquired bacteria that can build up on the breathing tube or pass through the tube to their lungs,
eventually causing a lung infection known as ventilator-associated pneumonia (VAP).
Fifteen percent of the patients on ventilators develop VAP every year and 26,000 die from the infection, according to the Centers for Disease Control and Prevention.
«Patients who require ventilator support are at increased risk for pneumonia, which poses a significant public health issue. This product can help to lower this risk,» said Daniel
Schultz, M.D., director of FDA’s Center for Devices and Radiological Health.
Silver has been known for its antimicrobial properties for decades and has been used for this purpose on several types of devices. This is the first endotracheal tube coated with silver.
In a multicenter clinical trial comparing the Agento breathing tube to an uncoated tube, the percentage of patients who developed pneumonia was reduced from 7.5 percent to 4.8 percent. The
Agento also delayed the onset of pneumonia.
The FDA in July issued a proposed guidance document on antimicrobial device submissions stating that when companies claim their product reduces or prevents device-related infections, the claim
should be supported by such clinical data.