Acclarent has reported that the INTACT study (sponsored by Acclarent), which has been recently published in the American Journal of Rhinology and Allergy, demonstrated Balloon Sinuplasty technology to be safe when used by physicians in pediatric patients.
In the prospective, non-randomized, multicenter study, 32 pediatric patients, between the ages of 2 and 11, had undergone minimally invasive sinus surgery with the Balloon Sinuplasty technology after previously failing medical management for 3-6 months and showing CT evidence of chronic sinusitis. These patients were followed for one year and effectiveness was assessed using the validated SN-5 quality of life questionnaire.
In the study, at one year follow up, 87% of patients have reported improvement in their sinus symptoms. The improvements in patient quality of life were maintained through one year. No adverse events were observed at any time point throughout the study.
Acclarent said that the authors have concluded that when patients are appropriately selected, preliminary results indicate that sinus ostial dilation using balloon catheters in children has a safety profile and may be an effective minimally invasive treatment option to relieve sinus ostial obstruction.
Balloon Sinuplasty technology is used to restore normal sinus drainage by widening constricted sinus passages with specially designed catheters and balloons. The technology has been used to treat over 100,000 patients since receiving FDA clearance in 2005 and can be used alone or with standard surgical instrumentation. Since 2005, more than 5,600 sinus surgeons have been trained on the use of Balloon Sinuplasty technology.
Hassan Ramadan, FACS of West Virginia University and lead author of the INTACT study, said: “The INTACT study affirms the safety of minimally invasive sinus surgery with Balloon Sinuplasty technology in children. The use of Balloon Sinuplasty technology at the time of adenoidectomy or after failed adenoidectomy is an option that should be considered prior to traditional sinus surgery.”