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Studies Confirm Balloon Sinuplasty(TM) Helps Chronic Sinusitis Patients
Date:4/13/2008

Research Verifies Technology Is Safe, Patient-Friendly, Economical

MENLO PARK, Calif., April 14 /PRNewswire/ -- Two independent studies published this week in American Journal of Rhinology and Annals of Otology, Rhinology, & Laryngology confirm Balloon Sinuplasty(TM) technology safely opens narrow sinuses, is economical and highly satisfactory to chronic sinusitis patients. The peer-reviewed studies analyzed outcomes of more than 1,100 individuals treated with this minimally-invasive balloon technology from Acclarent, a leading developer of innovative medical technologies for ear, nose and throat surgeons.

Chronic sinusitis is an inflammation of the nasal sinuses afflicting an estimated 37 million Americans annually. Symptoms include facial pain or pressure, nasal discharge, difficulty breathing through the nose, and fatigue. Although antibiotics and topical steroids can help many people, approximately 500,000 U.S. patients undergo surgery each year to alleviate the symptoms of chronic sinusitis.

Balloon Sinuplasty(TM) technology is similar in concept to catheters used in the heart for balloon angioplasty. The specially designed devices are threaded into the sinus passageways and gently inflated, widening the passages to promote drainage and resolution of chronic sinusitis symptoms. The technology can be used alone or with standard surgical instrumentation.

Recovery times vary but patients typically return to normal activities within 24 hours of treatment. Since 2005, more than 2,500 sinus surgeons have been 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 experienced less pain, according to data published in the current issue of American Journal of Rhinology. The 70 patient study also showed the total cost of these procedures was similar or lower for patients when compared with traditional surgical instrumentation.

"Our aim is to provide long lasting relief for our chronic sinusitis patients in a way that is more satisfying and less painful to recover from than the traditional surgical technique. Now we have a proven solution that allows us to provide this level of care with out additional cost in selected patients. This technique can be performed under local anesthesia and minimizes 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 and effective. More than 95 percent of the study's 1,036 patients enjoyed sinus symptom improvement over an average follow-up of 40 weeks and no adverse events were attributable to Balloon Sinuplasty(TM).

On behalf of the 34 surgeons who took part in the Annals study, Dr. Howard Levine, director of the Cleveland Nasal, Sinus and Sleep Center said, "The results from this study reinforce the outstanding safety record of Balloon Sinuplasty(TM) technology, and underscore its effectiveness in alleviating chronic sinusitis symptoms. Results were universally excellent across a large population of patients and dozens of different practices."

Bill Facteau, President and CEO of Acclarent, Inc., said, "These data further confirm the safety, efficacy, and high patient satisfaction that have previously been published in other studies on Balloon Sinuplasty(TM). The multiple investigators of these papers have also demonstrated the cost effectiveness and reported on the economic advantages to the healthcare system when 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 improving patient care in all areas of otolaryngology by developing and producing medical devices solely for Ear, Nose and Throat (ENT) specialists and their patients. Acclarent is demonstrating this by investing in innovative technologies, clinical studies, and physician training. The company received FDA clearance to market Balloon Sinuplasty(TM) technology in early 2005. For more information, visit http://www.acclarent.com.


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SOURCE Acclarent, Inc.
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