This summer FDA clearance was granted for Medtronic's NuVent^(TM), an electromagnetic (EM) sinus dilation system, for patients with scarred, granulated, or previously surgically altered tissue - an expansion of indications. NuVent is the first and only balloon sinus dilation system with built-in EM surgical navigation technology that may help surgeons confirm anatomy and optimize placement during balloon sinus surgery, according to published data.

"NuVent is an ingenious surgical tool that combines automatic calibration, precise electromagnetic navigation, and balloon dilation technology all in one device," said Rick Chandra, MD, professor of otolaryngology, chief of rhinology, sinus & skull base surgery, Vanderbilt University. "It has been extraordinarily useful in accomplishing the goals of revision functional endoscopic sinus surgery, particularly to address technical challenges associated with the frontal sinus."

Surgical navigation is important since sinus anatomy can be highly variable. NuVent was designed to work with image guidance technology called the Fusion^(TM) ENT Navigation System, which is a GPS-like navigation system that helps physicians target blocked sinuses during a minimally invasive surgery performed in the office. The expanded FDA clearance was based on the results of a prospective, non-randomized, non-blinded, single arm study conducted at investigational sites in the United States to assess the safety and device performance of the system.