Healthcare Industry News:  Balloon catheter 


 News Release - July 16, 2007

Study Confirms Balloon Sinuplasty(TM) Technology is Safe and Effective for Chronic Sinusitis Patients

Patients confirm significant improvement throughout six-month follow-up

MENLO PARK, Calif., July 16 (HSMN NewsFeed) -- An international, multi-center study of 109 patients confirmed Balloon Sinuplasty(TM) Instruments are safe and effective for opening blocked sinuses. Patients who participated in the study experienced significant relief from their symptoms associated with chronic sinusitis. Peer reviewed data published in the July 2007 issue of the prestigious journal "Otolaryngology-Head and Neck Surgery" showed 97% of the blocked sinuses were successfully opened with the technology. There were no adverse events and the treated sinuses showed remarkable patency throughout the study.

Chronic sinusitis is an inflammation of the nasal sinuses that afflicts an estimated 37 million Americans annually. Symptoms can be debilitating and include nasal discharge, sleep depravation, fatigue, headaches, facial pain, and chronic obstruction. Although antibiotics and topical steroids help most people, approximately 500,000 patients in the U.S. undergo surgery each year using a procedure called Functional Endoscopic Sinus Surgery (FESS). In a FESS procedure, a physician uses a small endoscope to see inside the nasal anatomy, and specialized surgical instruments to remove bone and tissue to enlarge the sinus openings.

Balloon Sinuplasty(TM) Instruments first received FDA clearance in December 2004. Unlike standard instruments for sinus surgery, these devices do not require any cutting or tissue removal. Similar in concept to catheters used in the heart for balloon angioplasty, Balloon Sinuplasty(TM) instruments can be threaded into small sinus passageways and then enlarged, thereby widening the passages to promote drainage and resolution of chronic sinusitis symptoms. These minimally invasive instruments are custom designed to work within the intricate sinus anatomy and can be used alone or in concert with standard surgical instruments during sinus surgery.

Recovery times vary but some patients return to normal activities within 24 hours of surgery. To date, more than 1,300 sinus surgeons have completed Acclarent's training program on the use of this technology and more than 10,000 patients have been treated across the United States.

"The results from this multi-center study indicate that Balloon catheter technology has an excellent safety profile and is an effective minimally invasive treatment option to relieve sinus ostial obstruction. Surgeons typically use tissue-cutting forceps and tissue shavers or microdebriders to open sinuses. Now surgeons have another instrument that allows them to relieve sinus obstruction by dilating rather than cutting," said lead author William Bolger, M.D., of the Maryland Sinus Center in Baltimore. "An important concern for surgeons trying new technology is the ability to achieve good results without introducing complications. We know that complications occur more frequently during the initial adoption period. However, this investigation indicates that serious complications related to the devices don't appear to accompany initial adoption."

The catheter-based Balloon Sinuplasty(TM) technology, developed and produced by Acclarent, Inc. of Menlo Park, California, was conceived by physician, engineer and chronic sinusitis sufferer Joshua Makower, M.D. Dr. Makower was successfully treated with his invention this May.

"I feel very confident in these data since 90% of the patients enrolled in the study returned for follow-up and showed significant benefit and improvement. This is one of the most comprehensive studies ever conducted in sinus surgery," 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 dilation of the sinus openings a major advancement in the treatment of chronic sinusitis."

A large percentage of chronic sinusitis is related to obstruction associated with swollen and inflamed membranes along the sinus passageways. Normally, the sinuses can produce up to a quart of mucous a day. When the sinuses are blocked, they can't drain properly and the retained fluids can become infected. Balloon Sinuplasty(TM) devices gently restructure the bones lining the sinus passageways, permanently widening the opening and allowing for drainage and restoration of normal function.

"I would like to thank all the investigators for their contributions to this groundbreaking trial," said Bill Facteau, President and CEO of Acclarent, Inc. "This is an important study that will be referenced for many years to come. As excited as we are with these results, even more gratifying are the outcomes of the now more than 10,000 patients that have been successfully treated since this watershed study was completed. We remain excited about the opportunity to bring this and many more innovative technologies forward to ENT surgeons and their patients in the months and years ahead."

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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