NuVent™ Revision Study

This is a prospective, non-randomized, single-arm study designed to assess the safety and device performance of the NuVent navigation-guided balloon system for use in subjects with scarred, granulated, or previously surgically altered tissue (revision).

Inclusion Criteria:

1. Subject is at least 18 years of age.
2. Subject has chronic rhinosinusitis unresponsive to medical therapy and previous sinus surgery.
3. Subject has sinus surgery planned on at least one of the frontal, sphenoid or maxillary sinus ostia.
4. Subject has scarred, granulated or previously surgically altered tissue for which an image-guided balloon tool may be feasible, in the opinion of the Investigator.
5. Subject is willing and able to comply with protocol requirements.

Exclusion Criteria:

1. Subject is pregnant or breastfeeding.
2. Subject is not healthy enough to undergo endoscopic sinus surgery based on the opinion of the Investigator.
3. Subject has sinonasal tumors.
4. Subject is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint.
5. Subject lacks capacity to consent to participation in this research himself/herself.