Medtronic’s NuVent sinus dilation device wins expanded indications from FDA

Medtronic (NYSE:MDT) said today that its NuVent sinus dilation device won expanded indications from the FDA.

The new indications cover patients with scarred, granulated, or previously surgically-altered tissue, according to the Fridley, Minn.-based medical device giant.

The device works with an electromagnetic navigation tool called Fusion, which is designed to help physicians confirm anatomy and optimize placement during balloon sinus surgery.

“As the 1st sinus dilation system for revision surgery and the 1st with built-in electromagnetic tracking, NuVent is an example of transformative technology that provides meaningful benefits to patients and physicians and it has the potential to help improve patient outcomes and reduce out-of-pocket costs,” ENT general manager Vince Racano said in prepared remarks. “Our innovative image-guided system used with NuVent provides surgeons with a detailed view of the sinus anatomy during the procedure and may enhance precision and allow physicians to help more patients in office.”

“NuVent is an ingenious surgical tool that combines automatic calibration, precise electromagnetic navigation, and balloon dilation technology all in one device,” added Vanderbilt University’s Dr. Rick Chandra. “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.”

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