The safety and performance of a maxillary sinus ostium self-dilation device: a pilot study.

BACKGROUND Balloon dilation is now commonly used to open sinus ostia while preserving mucosa and minimizing trauma. A new maxillary sinus ostium (MSO) self-dilation device that functions on the principle of osmosis, absorbing a small amount of fluid from the surrounding tissues, can be placed into the MSO under endoscopic visualization and slowly enlarge its outer diameter. The slower dilation may further minimize tissue damage and scarring compared to the currently available balloon dilation systems. The MSO self-dilating expansion device has never been studied before in clinical trials; the purpose of this pilot study is to determine the safety and performance of the device in human subjects. METHODS Twelve chronic rhinosinusitis (CRS) patients presenting with maxillary sinus inflammation requiring FESS were enrolled. The device was inserted into the MSO at the start of surgery and removed after 60 minutes. Endoscopic evaluation for patency was performed immediately after removal, and at 1 week, 1 month, and 3 months. Adverse events were recorded intraoperatively and at each subsequent visit. RESULTS The device was successfully inserted in 100% of cases attempted (19/19 MSOs, 12 patients). Seventeen (89%) devices remained in the MSO for 60 minutes and dilated to a mean diameter of 4.8 ± 0.5 mm. One patient was withdrawn from the study. No adverse events occurred during insertion or removal of the device. At 3 months postinsertion 14 of 15 MSO dilated (93%) were confirmed patent. CONCLUSION Placement of an osmotic self-dilating expansion device in human MSO is safe, achievable and effective at dilating the ostia.