Balloon sinuplasty, a novel surgical procedure in which a small balloon is inserted to open drainage from the sinus, is making headlines across the country, reports the New York Times. The surgical system is manufactured by Acclarent, Inc., a Menlo Park, California company. For millions of sinusitis sufferers, the procedure is touted as a breakthrough. The problems is that the procedure has never been shown to be effective for treatment of sinusitis.
From the NYT article:
The hype may be getting ahead of the science, say some leading sinus specialists, who concede that sinuplasty may hold promise. They see the rush to embrace balloon sinuplasty as an example of how the loose regulation of medical devices can enable procedures to be adopted more on the basis of astute marketing than clinical science.
Under the Food and Drug Administration rules governing medical devices, Acclarent was not required to demonstrate that its system was either safe or effective before the F.D.A. allowed it to go on the market last year. All Acclarent needed to show was that its device was essentially no different from other surgical tools already on the market.