Medical technology firm Entellus Medical has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its XprESS multi-sinus dilation system to treat pediatric patients.
The approval was granted to treat maxillary sinuses in patients aged two years and older, as well as in the treatment of frontal and sphenoid sinuses in patients aged 12 years and older.
Entellus said that it is the only firm to have FDA approval for balloon sinus dilation to treat frontal and sphenoid sinuses in adolescents.
Entellus Medical president and CEO Robert White said: "This achievement represents our continued commitment to transform the patient and physician experience by expanding the patient population for our technologies in the ENT market.
"I want to sincerely thank the Entellus team and all of the physicians and patients who participated in this clinical study."
The pediatric approval was based on the results of a prospective and multi-center study, under which 157 sinus dilations were carried out in 50 subjects.
According to the firm, the success was determined by whether the device could be delivered to the target location, inflated, deflated and withdrawn from the treated sinus.
In the study, all 157 attempts have been successfully completed for an overall XprESS technical success rate of 100%, said Entellus.
In September this year, the firm introduced new MiniFESS instruments and FocESS sinuscopes, which are claimed to reduce risk and time compared against traditional operating room procedure using general anesthesia.
Image: Pneumatized maxillary sinus. Photo: courtesy of DRosenbach.