FDA Grants Expanded Clearance to Entellus for XprESS Multi-Sinus Dilation System
Entellus Medical has won FDA 510(k) clearance for its XprESS multi-sinus dilation system for use in pediatric patients.
The device — designed to open narrowed or obstructed sinus drainage pathways using balloon sinus dilation — now is indicated to treat the maxillary sinuses in patients 2 years of age and older, and for the treatment of the frontal and sphenoid sinuses in patients 12 years of age and older.
The expanded clearance is based on a multi-center study of 50 subjects with a total of 157 sinus dilations attempted. The success rate was 100 percent, with no device- or procedure-related adverse events reported, the Plymouth, Minn.-based company says.
Robert White, president and CEO of Entellus, says the clearance broadens the company’s treatable patient population by approximately 10 to 20 percent. — Michael Cipriano