The US Food and Drug Administration (FDA) has granted 510(k) clearance for US-based medical technology firm Entellus Medical’s XprESS multi-sinus dilation system to treat paediatric patients.
FDA clearance was granted to treat maxillary sinuses in patients over the age of two and in the treatment of frontal and sphenoid sinuses in patients over the age of 12.
Entellus is claimed to be the only company to have received FDA clearance for balloon sinus dilation to treat frontal and sphenoid sinuses in adolescents.
Entellus Medical president 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.
"We anticipate that the ability to use Entellus products to treat paediatric 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."
Paediatric clearance was based on data from a prospective and multi-centre study, under which 157 sinus dilations were carried out in 50 subjects.
The company noted the success was determined by whether the device could be delivered to the target location, inflated, deflated and withdrawn from the treated sinus.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 trial, all attempts were successfully completed for an overall XprESS technical success rate of 100%. There were no device or procedure related adverse events reported during the study.
In September, the company introduced new MiniFESS instruments and FocESS sinuscopes, which are designed to reduce risk and time compared against traditional operating room procedure using general anaesthesia.
The MiniFESS family of products include eight steel surgical instruments, which were developed to enable procedures, including turbinate reductions and anterior ethmoidectomies to be carried out in the ENT physician office instead of the operating room.
