November 24, 2015
The FDA has granted Entellus Medical 501(k) clearance for their XprESS Multi-Sinus dilation system in pediatric patients, aged 2 years and older, according to a press release.
“Despite our greatest efforts, some pediatric patients continue to struggle with sinusitis symptoms and infections. Thanks to Entellus Medical and the XprESS balloon, we can now treat many of those patients who have not responded to traditional treatment options. This expanded indication from the FDA is an important milestone for the treatment of sinusitis in pediatric patients,” Douglas Skarada, MD, otolaryngologist, Willamette Ear Nose and Throat, Salem, Massachusetts, said in a press release.