Healthcare Industry News:  Balloon catheter 

Devices Otolaryngology

 News Release - September 19, 2006

Multi-Center Study Confirms Balloon Sinuplasty(TM) Technology Is Safe and Effective

Patients Confirm Significant Improvement Throughout 24-Week Follow-Up

TORONTO, Sept. 19 (HSMN NewsFeed) -- Balloon Sinuplasty(TM) technology used in treating patients with chronic sinusitis was found safe and highly effective in a multi-center study with 24-week follow-up. Data presented this morning at the annual American Academy of Otolaryngology, Head and Neck Surgery showed 109 patients were successfully treated with the technology at nine medical centers. There were no adverse events and sinuses were consistently opened and remained open during the study period.

Sinusitis afflicts an estimated 37 million Americans annually. Symptoms can include nasal discharge, headaches, facial pain and chronic obstruction. Although antibiotics and topical steroids help most people, surgical treatment is conducted in 350,000 patients annually. In those chronic cases, Functional Endoscopic Sinus Surgery (FESS) uses a small endoscope so the surgeon can see inside the nasal cavities. Specialized tools are then used to remove bone and tissue to enlarge the sinus opening.

Balloon sinuplasty technology is a new tool set for use in sinus surgery. 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 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. To date, more than 500 sinus surgeons have been trained in this technology, 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," said Fred Kuhn, M.D., founder of the Georgia Nasal & Sinus Institute in Savannah and past president of the American Rhinologic Society. "I consider balloon sinuplasty a major innovation in sinus surgery since it provides patients and ENT surgeons with an effective, minimally-invasive treatment option."

Catheter-based balloon sinuplasty technology is the brainchild of physician, engineer and chronic sinusitis sufferer Josh Makower, M.D. It has been developed and produced by Acclarent, Inc., of Menlo Park, California. The company received FDA clearance to market the technology in March, 2005. Commercial introduction was intentionally delayed until 2006 to accumulate clinical experience and develop a thorough training program.

"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," said Howard Levine, M.D., who headed The Cleveland Clinic's nose and sinus surgery program for 16 years before becoming director of the Cleveland Nasal, Sinus and Sleep Center in 1991. "I've treated more than 35 patients with these tools, and patients have consistently healed quickly and reported excellent, sustained results."

A percentage of chronic sinusitis is 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. When the sinuses are blocked, they cannot drain properly and the retained fluids can become infected. Balloon Sinuplasty technology works by gently restructuring the bones lining the sinus passageways, widening the opening and allowing for drainage and restoration of normal function. Unlike traditional approaches, this technology does not require the removal of bone and tissue, thus reducing the bleeding and pain commonly associated with sinus surgery.

"For a growing number of sinus conditions, this technology has changed the way I approach cases," said 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.

"I would like to thank all the investigators for their invaluable contributions to this watershed trial, said Bill Facteau, President and CEO of Acclarent, Inc. "As exciting as these results are, I think it is prudent to acknowledge that not all patients will be candidates for the Balloon catheter. People afflicted with chronic sinusitis should consult with their ENT surgeon to determine their best choices."

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. For more information, visit

Source: Acclarent

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