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To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

The BB 8 Sinus Dilation Kit is intended to remodel or recreate the sinus outflow tract via transnasal balloon dilation. The device combines features of a curved suction tip and a sinus ostium seeker with the tissue expansion effect of balloon dilation. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient. The device also allows the capability to suction and irrigate the surgical field to allow for removal of bodily secretions and to keep the field of view clean for improved visualization. The device includes an LED light with light fiber to locate, illuminate within, and transilluminate across nasal and sinus structures. In summary, the device includes the following components and accessories: 1. BB 8 Sinus Dilation Kit which incorporates: a. shapeable catheter with inflatable balloon b. LED light fiber c. irrigation line, and d. suction line, 2. Inflation syringe, 3. Extension line used for inflation of the balloon (and to provide irrigation, if desired), and 4. A bend template for shaping the catheter tip for treating various sinus anatomy