FDAnews Device Daily Bulletin

Medtronic Reports Positive Results for Device, Irrigation Solution

May 3, 2007

Medtronic recently presented study results suggesting pressurized irrigation of the sinuses along with an irrigation solution may reduce bacteria associated with chronic rhinosinusitis (CRS).

Of the Staphylococcus aureus and pseudomonas bacterial colonies grown in this study, 99.98 percent and 99.99 percent, respectively, of the bacteria were removed by the pressurized application, Medtronic said.

Mechanical disruption is one of the best mechanisms for removal of bacterial colonies, and the effect is often enhanced with a detergent, the company said. A common example is brushing teeth.

Irrigation devices under development by Medtronic adopt a similar approach for the treatment of CRS and chronic otitis media with effusion, the firm said. The company has filed a patent for a system that irrigates the nose with pressure. Medtronic has also developed and evaluated a variety of irrigating solutions to assist in the treatment. A citric acid zwitterionic surfactant provided the best results during internal testing, the company said. A patent application has been filed on the surfactant also.