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Study: Balloon Sinuplasty Safe

Balloon sinuplasty technology used to treat patients who have chronic sinusitis was found safe and highly effective in a multi-center study with 24-week follow-up that was conducted last year.

Research presented at last year's annual American Academy of Otolaryngology, Head and Neck Surgery showed 109 patients were successfully treated with balloon sinuplasty at nine medical centers. Sinuses were consistently opened and remained open during the study period.

"This new research confirms balloon sinuplasty technology is safe and effective. In fact, patient quality-of-life scores showed a statistically and clinically significant improvement throughout the 24-week study period," says Howard Levine, M.D., director of the Cleveland Nasal, Sinus and Sleep Center. "I've treated more than 35 patients with these tools, and patients have consistently healed quickly and reported excellent, sustained results."

Every year, more than 37 million Americans are affected by sinusitis. Symptoms typically include headaches, nasal discharge, facial pain and chronic obstruction. More than 350,000 patients a year undergo surgical treatment for their chronic sinusitis problem. In the surgical cases, Functional Endoscopic Sinus Surgery (abbreviated FESS) uses a small endoscope so the surgeon can see inside the nasal cavities. Specialized tools are then used to remove bone and tissue in order to enlarge the sinus opening.

Balloon sinuplasty technology is a new tool set developed for sinus surgeries. Similar in concept to catheters used in the heart for balloon angioplasty, balloon sinuplasty devices can be threaded into the sinus passageways and enlarged, widening the passages in order to promote drainage and resolution of chronic sinusitis symptoms. The technology can be used alone or with standard surgical tools. Recovery times vary but patients typically return to normal activities within 24-hours after their treatment.

To date, more than 500 sinus surgeons have been trained to use the ballon sinuplasty technique and more than 2,000 patients have been treated across the United States.

"This is one of the most comprehensive studies ever conducted in sinus surgery. We feel very confident in the data since 90 percent of the patients enrolled returned for their six month follow up and showed significant benefit and improvement," says Fred Kuhn, M.D., founder of the Georgia Nasal & Sinus Institute. "I consider balloon sinuplasty a major innovation in sinus surgery since it provides patients and ENT surgeons with an effective, minimally-invasive treatment option."

Some forms of chronic sinusitis are related to obstruction of the sinus ostium which is the area connecting the sinus to the nasal cavity. Normally, the sinuses can produce up to a quart of mucous a day. However, when blocked, the sinuses the sinuses cannot drain properly and the retained fluids can become infected. Balloon sinuplasty works by gently restructuring the bones lining the sinus passageways, thus widening the opening and allowing for normal drainage and functgion. Unlike traditional approaches, this technology does not require the removal of bone and tissue. As a result bleeding and pain, often associated with sinus surgery, are drastically reduced.

"For a growing number of sinus conditions, this technology has changed the way I approach cases," says Ray Weiss, M.D., who has treated more than 100 patients with balloon sinuplasty technology at the Sinus Center of the South in Biloxi, Mississippi. "It wasn't designed to remove polyps or treat ethmoid sinus disease. But for patients who have a chronic blocked frontal, maxillary or sphenoid sinus, experience has shown this is a fast, gentle way to treat the problem without the bleeding and trauma associated with conventional cutting tools."

The ten authors of this report, entitled "Safety and Efficacy of Balloon Catheter Sinusotomy: A Multi-center 24 Week Analysis in 115 Patients," are William E. Bolger, M.D., from the Maryland Sinus Center, Bethesda, M.D.; Christopher L. Brown, M.D., from the Sandringham District Memorial Hospital, Bayside Network, Melbourne, Australia; Christopher A. Church, M.D., at the Loma Linda University, Loma Linda, CA; Andrew N. Goldberg, M.D., MSCE, at the University of California-San Francisco, San Francisco, CA; Boris Karanfilov, M.D., Ohio Sinus Institute, Columbus, OH; Frederick A. Kuhn, M.D., Georgia Nasal and Sinus Institute, Savannah, GA; Howard L. Levine, M.D., Cleveland Nasal, Sinus and Sleep Center, Cleveland, OH; Michael J. Sillers, M.D., Alabama Nasal and Sinus Center, Birmingham, AL; Winston C. Vaughan, M.D., California Sinus Institute, Palo Alto, CA; and Raymond L. Weiss, M.D., from the Sinus Center of the South, Biloxi, MS.  


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