New treatment option for chronic sinusitis

Sep 26 2005

Acclarent on Saturday unveiled their new treatment option for chronic sinusitis, the Balloon Sinuplasty procedure. Results from the initial safety and feasibility study of this unique, catheter-based treatment for chronic sinusitis were presented by William Bolger, MD, FACS.

Dr. Bolger, a recognized expert in sinus surgery, presented to surgeons attending the Annual American Rhinologic Society meeting. Instead of conventional sinus surgery that involves bone and tissue removal, this procedure threads a small flexible balloon through the sinus passageways, gently dilating the openings of the sinuses and allowing for immediate drainage.

"This technology provides a novel treatment option for patients suffering from chronic sinusitis," said Dr. Bolger. "Over the years we have realized that preserving the mucosa, the layer of tissue covering the sinuses, is very important for good long term results. By using the Balloon Sinuplasty procedure we have an opportunity to truly minimize the trauma and bleeding to our patients and improve their outcome through the preservation of the mucosa."

The pre-clinical data presented by Dr. Bolger reviewed the results he achieved in conjunction with Dr. Winston Vaughan (Palo Alto, CA). The study evaluated the feasibility and safety of Balloon Sinuplasty catheters to relieve sinus ostial obstruction. Feasibility and procedural success was demonstrated through 100% dilation of the target sinuses. The comparison of pre and post CT scans, multi-angled endoscopic views, and gross examination confirmed the safety of this technique.

Based on the positive pre-clinical study, a pilot study of 10 patients was conducted by Dr. Christopher Brown (Melbourne, Australia). In these 10 patients, 18 balloon dilation procedures were performed on 18 sinuses. The balloon catheter successfully dilated the ostium in all patients without any complications or adverse events.

In an ongoing effort to further confirm the safety and efficacy of the Balloon Sinuplasty procedure, Acclarent, Inc. is collaborating with thought leaders in the field of otolaryngology to conduct The CLinical Evaluation to Confirm SAfety and Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR) Study. The investigators are: Dr. Christopher Brown (Melbourne, Australia), Dr. Christopher Church (Loma Linda, CA), Dr. Andrew Goldberg (San Francisco, CA), Dr. Boris Karanfilov (Columbus, OH), Dr. Frederick Kuhn (Savannah, GA), Dr. Howard Levine (Cleveland, OH), Dr. Michael Sillers (Birmingham, AL), Dr. Winston Vaughan (Palo Alto, CA), and Dr. Raymond Weiss (Biloxi, MS). Currently, this study has enrolled over 65 patients, and the physicians continue to report excellent outcomes.

"This technology has the potential to significantly change how we manage our patients everyday," said Dr. Michael Sillers from Birmingham, AL.

After placing a small guiding catheter into the nose under endoscopic vision, a small guidewire is introduced into the sinus targeted for therapy. Once the sinus is accessed, a proprietary balloon device developed by Acclarent, Inc. (Menlo Park, CA) called the Relieva Sinus Balloon Catheter is introduced into the swollen sinus passageway under x-ray guidance. The Relieva Sinus Balloon catheter is then dilated, gently restructuring and widening the walls of the passageway, maintaining the integrity of the sinus lining and allowing for immediate drainage of trapped secretions.

"This technology is indeed an eye opener and should make sinus surgery more complete," said Dr. Michael Setzen from Manhasset, NY, "The Balloon Sinuplasty procedure is extremely exciting and will be beneficial to both sinus surgeons and patients."

Sinusitis affects approximately 37 million people in the U.S. each year, comprising 18-22 million office visits, making it one of the most prevalent chronic conditions, even greater than hypertension and arthritis. Bill Facteau, the CEO of Acclarent, Inc. said, "We believe this is a natural evolution of surgery, just like angioplasty was for coronary bypass surgery."

"We have spent considerable time and effort developing this novel, catheter-based technology that will serve as the foundation for the new Balloon Sinuplasty procedure. We believe that our new system will provide Ear, Nose and Throat (ENT) doctors around the world new treatment options that will help to facilitate the goals of sinus surgery with much less bleeding and trauma to the surrounding tissue."

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