Research Presented at ENT Rhinology Conference Adds to the Clinical Evidence Supporting Entellus Medical’s FinESS™ Sinus Treatment
Studies Confirm Office-Based Balloon Sinus Dilation Delivers Significantly Improved Quality of Life for Chronic Sinusitis Patients
MINNEAPOLIS, MINNESOTA – September 12, 2011 - Entellus Medical, a Minnesota-based medical technology company, announced today that results of two clinical research studies presented at the annual American Rhinologic Society meeting in San Francisco support the efficacy of Entellus Medical’s™ FinESS™ Sinus Treatment, a balloon dilation procedure for chronic sinusitis.
Dr. James Atkins presented the results from a prospective registry study of 155 patients who underwent balloon dilation with FinESS either as a standalone procedure or in combination with sinonasal surgical procedures. Ostial dilation of the maxillary sinuses was performed in all enrolled patients and each physician determined if additional surgical procedures such as septoplasty or endoscopic sinus surgery were also needed for a particular patient.
Data presented by Dr. Atkins showed that chronic and recurrent sinusitis patients treated with FinESS, either as a standalone procedure or in combination with sinonasal surgical procedures experienced a statistically significant and clinically meaningful 52% improvement in their sinus symptoms, significantly reduced post-procedure use of antibiotics, with balloon-only patients experiencing the largest decrease (71%), and significantly reduced the number of physician visits due to sinus problems through one-year follow-up.
Dr. James Stankiewicz presented two-year follow-up data from a prospective study of 59 patients who underwent standalone balloon dilation to treat chronic sinusitis with inflammation in the maxillary sinus alone or maxillary and anterior ethmoid sinuses. One-year results from this study (BREATHE I) have been previously published and follow-up was extended an additional year to further evaluate the long-term durability of ostial dilation.
Dr. Stankiewicz reviewed the data that demonstrated chronic sinusitis patients treated with FinESS Sinus Treatment experienced on average a 70% improvement in their sinus symptoms that was both statistically significant and clinically meaningful. Symptom improvement was sustained through two years and over 90% of patients were satisfied with the procedure. In addition, patient’s work productivity and physical activity also improved significantly through two years.
“These results affirm the long-term durability of improvement in symptom and activity measures post-treatment with standalone balloon dilation,” said Dr. Stankiewicz. “More important, these patients experienced a sustained clinically meaningful improvement in their sinus symptoms and a significant improvement in quality of life following treatment with the FinESS procedure.”
“These studies demonstrate that when balloon dilation with FinESS is used in everyday clinical practice, either as a standalone procedure or in conjunction with other sinonasal procedures, patients continue to experience sustained relief of chronic sinusitis symptoms and can look forward to less use of antibiotics for sinus infections,” said Dr. Atkins.
The Entellus FinESS system treats the two most commonly inflamed sinuses, the maxillary and anterior ethmoid sinuses. Designed to be performed in the doctor’s office setting, FinESS is the only balloon dilation system on the market that predictably allows direct visualization of the maxillary sinus opening, ensuring treatment of the natural sinus drainage pathways.
About Entellus Medical
Entellus Medical (www.EntellusMedical.com) provides complete solutions for the minimally invasive treatment of chronic and recurrent sinusitis patients and is leading the way with easy-to-use, cost-effective products designed for office-based balloon dilation of narrowed sinus pathways. With this approach, Entellus sinus dilation products also provide significant efficiency and cost-effectiveness for sinus dilation procedures performed in operating rooms. For more information on FinESS™ Sinus Treatment, XprESS™ Multi-Sinus Dilation Tool or PathAssist™ sinus confirmation tools visit http://www.EntellusMedical.com.
Mike Gaynes – 650-728-0227