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Studies Confirm Balloon Sinuplasty(TM) Helps Chronic Sinusitis Patients

Monday, April 14, 2008 General News
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MENLO PARK, Calif., April 14 Two independent studiespublished this week in American Journal of Rhinology and Annals of Otology,Rhinology, & Laryngology confirm Balloon Sinuplasty(TM) technology safelyopens narrow sinuses, is economical and highly satisfactory to chronicsinusitis patients. The peer-reviewed studies analyzed outcomes of more than1,100 individuals treated with this minimally-invasive balloon technology fromAcclarent, a leading developer of innovative medical technologies for ear,nose and throat surgeons.
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Chronic sinusitis is an inflammation of the nasal sinuses afflicting anestimated 37 million Americans annually. Symptoms include facial pain orpressure, nasal discharge, difficulty breathing through the nose, and fatigue.Although antibiotics and topical steroids can help many people, approximately500,000 U.S. patients undergo surgery each year to alleviate the symptoms ofchronic sinusitis.
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Balloon Sinuplasty(TM) technology is similar in concept to catheters usedin the heart for balloon angioplasty. The specially designed devices arethreaded into the sinus passageways and gently inflated, widening the passagesto promote drainage and resolution of chronic sinusitis symptoms. Thetechnology can be used alone or with standard surgical instrumentation.

Recovery times vary but patients typically return to normal activitieswithin 24 hours of treatment. Since 2005, more than 2,500 sinus surgeons havebeen trained on this technology and treated more than 25,000 patients.

Studies Confirm Balloon Sinuplasty(TM) Benefits

Patients who underwent sinus surgery using Balloon Sinuplasty(TM)technology were more satisfied, felt better post-operatively and experiencedless pain, according to data published in the current issue of AmericanJournal of Rhinology. The 70 patient study also showed the total cost ofthese procedures was similar or lower for patients when compared withtraditional surgical instrumentation.

"Our aim is to provide long lasting relief for our chronic sinusitispatients in a way that is more satisfying and less painful to recover fromthan the traditional surgical technique. Now we have a proven solution thatallows us to provide this level of care with out additional cost in selectedpatients. This technique can be performed under local anesthesia andminimizes risk to the patients," said lead author and surgeon Michael Friedman,M.D., of The Advanced Center for Specialty Care in Chicago.

Separate data in the April 2008 issue of Annals of Otology, Rhinology, &Laryngology also concluded Balloon Sinuplasty(TM) instrumentation is safe andeffective. More than 95 percent of the study's 1,036 patients enjoyed sinussymptom improvement over an average follow-up of 40 weeks and no adverseevents were attributable to Balloon Sinuplasty(TM).

On behalf of the 34 surgeons who took part in the Annals study, Dr. HowardLevine, director of the Cleveland Nasal, Sinus and Sleep Center said, "Theresults from this study reinforce the outstanding safety record of BalloonSinuplasty(TM) technology, and underscore its effectiveness in alleviatingchronic sinusitis symptoms. Results were universally excellent across a largepopulation of patients and dozens of different practices."

Bill Facteau, President and CEO of Acclarent, Inc., said, "These datafurther confirm the safety, efficacy, and high patient satisfaction that havepreviously been published in other studies on Balloon Sinuplasty(TM). Themultiple investigators of these papers have also demonstrated the costeffectiveness and reported on the economic advantages to the healthcare systemwhen using this established tool in sinus surgery."

About Acclarent

Acclarent, Inc. is a privately held medical device company in Menlo Park,CA that was established in June of 2004. Its singular focus is improvingpatient care in all areas of otolary
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