XprESS Registry Study

XprESS Registry Study

This is a prospective, non-randomized, multi-center study to assess safety and long-term patency of the ostia treated with the XprESS device per the device indication for use (IFU).

Endoscopic balloon-only and hybrid-balloon procedures involving dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia were performed in 175 patients.

One-month follow-up was required for all patients. The first 50 patients enrolled also consented to a 1-year follow-up. Complications and sinus symptom severity were assessed at the 1-month visit. Symptom severity and ostial patency of the treated sinuses were evaluated at the 1-year visit.

Inclusion Criteria:

• 18 years of age or older
• Scheduled to undergo sinus surgery with planned use of the XprESS Balloon Device consistent with the tool's Indication for Use
• Willing and able to provide consent

Exclusion Criteria:

• Known Samter's Triad
• History of primary ciliary dysfunction
• History of cystic fibrosis
• Known to be immunosuppressed
• Hemophilia
• Currently enrolled in another pre-approval investigational study