Entellus Medical Receives FDA Clearance for XprESS Multi-Sinus Dilation System in Pediatric Patients
PLYMOUTH, Minn., Nov. 23, 2015 (GLOBE NEWSWIRE) -- Entellus Medical, Inc. (NASDAQ:ENTL), a medical technology company focused on delivering superior patient and physician experiences through products designed for the minimally invasive treatment of chronic and recurrent sinusitis patients, today announced the Company has received 510(k) clearance from the United States Food and Drug Administration (“FDA”) for use of its XprESS Multi-Sinus Dilation System in pediatric patients.
This FDA clearance for the XprESS Multi-Sinus Dilation System expands the patient population to include treatment of maxillary sinuses in patients 2 years and older, and treatment of the frontal and sphenoid sinuses in patients 12 years and older. Entellus Medical is the only company to have received FDA clearance for balloon sinus dilation to treat the frontal and sphenoid sinuses in adolescents.
“Despite our greatest efforts, some pediatric patients continue to struggle with sinusitis symptoms and infections,” said clinical investigator, Douglas Skarada, M.D., Willamette Ear, Nose, Throat, and Facial Plastic Surgery. “Thanks to Entellus Medical and the XprESS balloon, we can now treat many of these 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, and I am proud to have been part of this endeavor.”
Pediatric clearance for XprESS follows completion of a prospective, multi-center study to support the expanded indications. A total of 157 sinus dilations were attempted in 50 subjects. Success was determined by whether the device could be delivered to the target location, inflated, deflated and withdrawn from the treated sinus. All 157 attempts were successfully completed for an overall XprESS technical success rate of 100%. There were zero device or procedure related adverse events reported during the clinical study.
“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,” said Robert White, President and Chief Executive Officer of Entellus Medical. “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 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.”
About Chronic Sinusitis and Balloon Sinus Dilation
Chronic sinusitis affects approximately 29 million adults and approximately 6 million children in the United States, making it one of the most common health problems in the United States. It is more prevalent than heart disease and asthma, and has a negative impact on quality of life with chronic symptoms and effects including facial pain and pressure, headaches, fatigue, loss of smell, and sinus infections.
About Entellus Medical, Inc.
Entellus Medical is a medical technology company focused on delivering superior patient and physician experiences through products designed for the minimally invasive treatment of chronic and recurrent sinusitis patients. The Entellus Medical platform of products provides physicians with solutions to aid in the diagnosis and treatment of patients suffering from chronic sinusitis. Its XprESS family of products is used by ENT physicians to open narrowed or obstructed sinus drainage pathways using balloon sinus dilation. When used as a stand-alone therapy, Entellus Medical’s balloon sinus dilation products are the only devices proven in a sufficiently powered prospective, multicenter, randomized, controlled trial to be as effective as functional endoscopic sinus surgery (“FESS”). Patients treated with Entellus Medical’s products in this trial in the ENT physician’s office also experienced faster recovery, less bleeding at discharge, less use of prescription pain medication and fewer post-procedure debridements than patients receiving FESS. In addition to its XprESS line of products, Entellus Medical has recently introduced additional products designed to aid in the diagnosis, treatment and post-operative care of patients suffering from chronic sinusitis.
Entellus Medical currently markets its products in the United States, Europe and Canada and sells its products through a direct sales force in the United States and the United Kingdom. For more information, please visit the Company’s website at www.entellusmedical.com.
Forward-Looking Statements
All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current expectations of Entellus Medical’s management and involve known and unknown risks and uncertainties that may cause Entellus Medical’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, adoption by ENT physicians of the Company’s products in treating adolescents suffering from sinusitis. Other factors that could cause actual results to differ materially from those contemplated in this press release can be found under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014 filed with the Securities and Exchange Commission (“SEC”), and in its other reports filed with the SEC. Entellus Medical undertakes no obligation to update or revise any forward-looking statements, even if subsequent events cause its views to change.
CONTACT: Leigh Salvo 415-513-1281 ir@entellusmedical.com
