Dr. Marty Makary, U.S. Food and Drug Administration (FDA) Commissioner | FDA
Patient Daily | Jul 25, 2025

Balloon sinuplasty marks 20 years since FDA approval

StatPearls has announced that balloon sinuplasty has reached its 20th anniversary since receiving approval from the U.S. Food and Drug Administration for use in nasal sinus procedures. This announcement was made in an educational publication.

Balloon sinuplasty is a minimally invasive procedure used to treat chronic rhinosinusitis, a condition affecting approximately 12% of adults in the United States. According to Medical News Today, it involves inflating a small balloon in the sinus cavity to restore normal drainage without cutting tissue. The procedure is often recommended when medications fail and may result in quicker recovery.

Between 2006 and 2011, balloon sinuplasty procedures in the U.S. increased by 7%, with most performed in outpatient settings. Researchers from West Virginia University found this growth was driven by its clinical flexibility and ability to be done under local anesthesia. The study utilized national data to track utilization trends and procedural shifts.

A 2023 study published in the National Library of Medicine analyzed outcomes for over 2,800 patients who underwent balloon sinuplasty, reporting a 5.26% complication rate. In comparison, conventional endoscopic sinus surgery shows higher complication rates, with some studies reporting up to 7% depending on procedure complexity. The review concluded that balloon sinuplasty generally offers fewer complications and a lower revision rate.

StatPearls provides clinical education on procedures such as balloon sinuplasty, supporting healthcare professionals with peer-reviewed content. Its platform includes more than 8,000 medical topics and continuing education tools used across disciplines. StatPearls states that the organization collaborates with thousands of authors to maintain clinical accuracy.

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