New Studies Confirm Safety, Effectiveness of Balloon Sinuplasty(TM) Technology for Chronic Sinusitis
The foundation for those studies was a six-month clinical trial calledCLEAR that began in 2005. It included 109 patients who had minimally invasivesinus surgery with the Balloon Sinuplasty(TM) technology. They participated inone-year and two-year follow-up studies which reported:
Balloon Sinuplasty(TM) technology is used to restore normal sinus drainageby widening constricted sinus passages with specially designed catheters andballoons. The technology has been used to treat over 40,000 patients sincereceiving FDA clearance in 2005 and can be used alone or with standardsurgical instrumentation.
The Center for Disease Control data reports sinusitis is among the mostcommon illnesses in the U.S., affecting an estimated 37 million Americans andleading 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 functionnormally, while preserving as much natural anatomy as possible. With BalloonSinuplasty(TM) technology, we are able to accomplish that goal with ourcurrent approach in a true minimally invasive way, and give our patients therelief they have been seeking," said Frederick A. Kuhn, M.D. of the GeorgiaNasal and Sinus Institute in Savannah, and lead author of the one-yearoutcomes study.
"These multi-year data continue to affirm the safety and effectiveness ofBalloon Sinuplasty(TM) technology. Patients can feel confident that thistechnology truly provides significant, durable improvement in sinus symptomsand overall quality of life," said otolaryngologist Raymond Weiss, M.D. of theSinus Center of the South in Biloxi, and lead author of the two-year study.
Recovery times vary after sinus surgery, but patients typically return tonormal activities within 24 hours of treatment. Since 2005, more than 4,000sinus surgeons have been trained to use Balloon Sinuplasty(TM) technology.
Bill Facteau, President and CEO of Acclarent, Inc. said, "We are verypleased with the 1- and 2-year results of the CLEAR Study. It is evident fromthese data that when Balloon Sinuplasty(TM) devices are used in sinus surgerythey are safe, effective, and significantly improve a patient's quality oflife."
Acclarent, Inc. is a privately held medical device company located inMenlo Park, CA. Its singular focus is improving patient care in all areas ofotolaryngology by developing and producing medical devices solely for Ear,Nose and Throat (ENT) specialists and their patients. Acclarent isdemonstrating this by developing innovative technologies, and investing inclinical studies and physician training. For more information, visitwww.acclarent.com or www.BalloonSinuplasty.com.-- 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.
SOURCE Acclarent, Inc.
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