The FDA expanded the indication for Medtronic’s ($MDT) NuVent sinus dilation balloon to include patients with scarred, granulated or previously surgically altered tissue.
The device is currently the only balloon sinus dilation system on the market with built-in electromagnetic surgical navigation that helps surgeons confirm sinus anatomy and place the balloon during surgery. It uses an image guidance technology called Fusion, which displays a “map” of the sinus anatomy, helping physicians precisely target points in blocked sinuses for dilation during minimally invasive surgery.
The expanded indication is based on a prospective, nonrandomized, nonblinded, single-arm study conducted at multiple sites in the U.S. According to the CDC, 29.4 million adults have diagnosed sinusitis in the U.S. While the bulk of these cases are treated with antibiotics, decongestants and saline sprays, some patients must undergo sinus surgery to find relief.
Medtronic launched NuVent in August 2014 for sinus surgery. The new clearance will make the NuVent system an option for patients who need revision sinus surgery. Revision surgery is required by patients for whom the initial sinus surgery did not work. It can be challenging due to scar tissue and differences in anatomy caused by previous surgeries.
"[NuVent] has been extraordinarily useful in accomplishing the goals of revision functional endoscopic sinus surgery, particularly to address technical challenges associated with the frontal sinus,” said Dr. Rick Chandra, professor of otolaryngology at Vanderbilt University, in the statement.
- here's the statement
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