Technology | June 12, 2008

FDA Clears Silver-Coated Endotracheal Tube to Prevent VAP

The FDA recently gave 510(k) clearance for C.R. Bard’s Agento I.C. silver-coated intermediate high volume low pressure endotracheal tube for airway management in cases where duration of intubation is expected to be 24 hours or longer to help prevent infections or confirmed ventilator associated pneumonia (VAP).

The FDA’s summery said the Agento I.C. showed a 36 percent reduce the incidence of VAP in patients intubated for 24 hours or longer.

The Bard silver-coated endotracheal tube is a sterile bifurcated (two-characteristics lumen) polyvinyl chloride tube with a polyvinyl chloride cuff. The tube design incorporates a Magill curve and features a radiopaque line to assist radiographic visualization. The tube is available with a hooded Murphy tip, an intermediate high volume, low-pressure cuff and self-sealing valve with attached pilot balloon. The tube is for adults only, and comes in sizes 6, 6.5, 7, 7.5, 8, 8.5, 9, and 10mm.

The silver coating is on the outer tube surface, including the cuff surface and on the interior surface of the airway lumen.

June 2008