Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium

SinuSys Patency of Maxillary Sinus Ostia Study

The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.

A multicenter, single-arm, prospective study conducted to assess the safety and effectiveness of a new osmotically-driven, low-pressure expansion device for dilation of maxillary sinus ostia in patients with (CRS) Chronic Rhinosinusitis

Inclusion Criteria:

-Diagnosis of chronic maxillary sinusitis

Exclusion Criteria:

• Previous antrostomy
• Sinonasal tumours
• Cystic fibrosis
• History of facial trauma that distorts sinus anatomy and precludes access to the maxillary sinus
• Pregnant or breastfeeding females
• Currently participating in another drug or device study