DUBLIN - July 11, 2016 - Medtronic plc (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) clearance of NuVent(TM), an EM sinus dilation system, for patients with scarred, granulated, or previously surgically-altered tissue - an expansion of indications. Patients coming in for revision sinus surgery (RSS) have these tissue characteristics. NuVent is the first and only balloon sinus dilation system with built-in electromagnetic (EM) surgical navigation technology that may help surgeons confirm anatomy1 and optimize placement2 during balloon sinus surgery. RSS may be needed when sinus surgery does not alleviate suffering, and can pose unique challenges due to potential scar tissue and altered anatomy from previous surgeries. Image-guided surgery may have advantages for some types of revision cases.3

"NuVent is an ingenious surgical tool that combines automatic calibration, precise electromagnetic navigation, and balloon dilation technology all in one device," said Rick Chandra, M.D., 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 because 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 sinuses4 during a minimally invasive surgery5 performed in the office. Fusion(TM) navigation technology helps physicians confirm specific anatomy, avoid critical areas,6 and optimize balloon placement to open blocked pathways.It works like GPS in a car or on a phone and displays a visual map of the sinus anatomy. This may help surgeons steer the balloon to the blocked sinuses to inflate the balloon at the precise location to reshape(dilate)the tissue and bone to clear the sinus pathway.


When performed in the doctor's office, this procedure is minimally invasive, offers faster recovery times4 and may allow eligible patients to have a lower out-of-pocket cost.7

The FDA clearance of NuVent for patients who have scarred, granulated, or previously altered tissue (revision) 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.

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