New Studies Confirm Safety, Effectiveness of Balloon Sinuplasty(TM) Technology for Chronic...( Patients show significant impr...),Health

Patients show significant improvement through 2-year follow-up

MENLO PARK, Calif., Sept. 22 /PRNewswire/ -- Two multicenter studies published this week in Otolaryngology - Head and Neck Surgery confirm Balloon Sinuplasty(TM) technology is safe and effective when used by physicians to treat chronic sinusitis patients.

The foundation for those studies was a six-month clinical trial called CLEAR that began in 2005. It included 109 patients who had minimally invasive sinus surgery with the Balloon Sinuplasty(TM) technology. They participated in one-year and two-year follow-up studies which reported:

-- 92% functional patency at one-year follow-up.

-- At two-year follow-up, 85% of patients reported improvement in their

sinus symptoms. No patient's condition worsened.

-- Clinically and statistically significant improvements in patient

quality of life maintained at one and two year follow-up.

-- No serious adverse events observed at any time point throughout the

study.

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 40,000 patients since receiving FDA clearance in 2005 and can be used alone or with standard surgical instrumentation.

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. Symptoms include repeated infections, headaches, facial pain, persistent congestion and unrelenting fatigue.

"The goal of sinus surgery is to open the sinuses so they can function normally, while preserving as much natural anatomy as possible. With Balloon Sinuplasty(TM) technology, we are able to accomplish that goal with our current approach in a true minimally invasive way, and give our patients the r
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