Balloon Sinuplasty - History

History

Balloon sinuplasty technology was developed by Acclarent, Inc., and was brought to market in 2005, following FDA approval. Patients with sinus disease in the maxillary sinus (under the cheek), frontal sinus (over the eyes), and sphenoid sinus (in the middle of the head)caused by obstruction may benefit from balloon procedures. Balloon sinus technology is not used in the ethmoid sinus (between the eyes) because of the risk of damage to the eye (double vision, damage to vision or blindness) with balloon inflation. Balloon sinus procedures are occasionally used alone to manage disease in the frontal, maxillary or sphenoid sinuses, or can be combined with more traditional sinus technologies. A weakness of balloon procedures is the difficulty in obtaining valuable, accurate culture and biopsy information from the sinuses. Culture and biopsy information is often a chief reason for undergoing a sinus surgery, and accurate results can impact postoperative therapy and long term prognosis. While manufacturers of balloon products assert that this information can be obtained, the exposure and collection gathering techniques are far inferior with balloon procedures versus standard endoscopic sinus surgery, and so-called "hybrid procedures" (combining standard techniques with balloons) prolong operative time and increase expense. When performed as an isolated procedure, balloons have a high safety record. There remains a small risk of damage to the brain and eyes.

As with any sinus surgery, additional treatment medically or surgically may be needed depending on the cause of the sinus disease.