MENLO PARK, Calif., March 2 A recently published study in the American Journal of Rhinology and Allergy demonstrates Balloon Sinuplasty(TM) technology to be safe when used by physicians in pediatric patients. Known as the INTACT study, this is a prospective, non-randomized, multicenter study and was sponsored by Acclarent, Inc.
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Thirty-two pediatric patients, between the ages of 2 and 11, underwent minimally invasive sinus surgery with the Balloon Sinuplasty(TM) 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.
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At one year follow up, 87% of patients reported improvement in their sinus symptoms. Statistically significant improvements in patient quality of life were maintained through one year. No adverse events were observed at any time point throughout the study. The authors concluded that when patients are appropriately selected, preliminary results indicate that sinus ostial dilation using balloon catheters in children has an excellent safety profile and may be an effective minimally invasive treatment option to relieve sinus ostial obstruction.
Balloon Sinuplasty(TM) 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(TM) technology.
The Center for Disease Control data reports sinusitis is among the most common illnesses in the U.S., affecting an estimated 37 million Americans and leading to 500,000 surgeries a year. Pediatric patients make up 22% of all office visits for chronic sinusitis(1). Symptoms include repeated infections, headaches, facial pain, persistent congestion, cough and fatigue.
"The INTACT study affirms the safety of minimally invasive sinus surgery with Balloon Sinuplasty(TM) technology in children. The use of Balloon Sinuplasty(TM) technology at the time of adenoidectomy or after failed adenoidectomy is an option that should be considered prior to traditional sinus surgery," said Hassan Ramadan, M.D., MSc, FACS of West Virginia University, and lead author of the INTACT study.
All medical procedures contain risks. Although rare, the risks associated with Balloon Sinuplasty(TM) technology include tissue and mucosal trauma, infection, or possible optic injury. Consult your physician for a full discussion of risks and benefits to determine whether this procedure is right for you or your child.
About Acclarent
Acclarent, Inc., a business unit of Ethicon, Inc. (www.Ethicon.com), is a medical device company located in Menlo Park, CA. Its singular focus is improving patient care in all areas of otolaryngology by designing, developing and commercializing medical devices that address conditions affecting the ear, nose and throat (ENT). Acclarent is demonstrating this by developing innovative technologies, and investing in clinical studies and physician training. For more information, visit www.acclarent.com or www.BalloonSinuplasty.com.
American Journal of Rhinology & Allergy, Volume 24, Number 1, January/February 2010 , pp. e54-e56(1)
(1) Benninger, M., Otolaryngology Head and Neck Surgery 2003; 129S: S1-S32
SOURCE Acclarent, Inc.
