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.
The clearance allows for expanded treatment populations, including maxillary sinus treatment in patients aged 2 years and older, and frontal and sphenoid sinus treatment in patients aged 12 years and older.
The FDA’s decision comes after results from a recent prospective, multicenter study showed 100% technical success in the device’s ability to be delivered, inflated, deflated and withdrawn from the treated sinuses (n = 157) in 50 patients. No adverse events related to either the procedure or device were found during the study, according to the release.
Nearly 6 million children are affected by chronic sinusitis, which can cause facial pain and pressure, headaches, fatigue, loss of smell and sinus infections each year, according to the release.
“We anticipate that the ability to use Entellus products to treat pediatric patients broadens our treatable patient population by approximately ten to twenty percent; an exciting prospect as we diligently work to improve the lives of patients suffering from sinusitis and to provide our highly efficacious solution that is designed to reduce costs to the healthcare system and to patients,” Robert White, president and CEO of Entellus Medical, said in the release.