Clinical Data

Pre-Clinical Safety and Feasibility Study
This study was performed by leading experts in the field of otolaryngology to evaluate the feasibility and safety of Balloon Sinuplasty™ catheters in relieving sinus ostial obstruction. The Sinus Balloon Catheters easily cannulated and dilated the maxillary, frontal, and sphenoid ostia, demonstrating feasibility. Sinonasal endoscopy and computerized tomography (CT) were performed on anatomic specimens before and after the use of Sinus Balloon Catheters. Analysis revealed that sinus ostial dilation was achieved without damage to surrounding structures. Importantly, the orbital bone and skull base, which are adjacent to the paranasal sinuses, were not affected by Sinus Balloon Catheter dilation of the sinus ostia. Endoscopy and CT scans also revealed that the sinus ostial size achieved by the Sinus Balloon Catheter was comparable to the maximum balloon diameter. Following CT and endoscopic analysis, gross anatomic dissection was performed to further validate the endoscopic and CT scan analysis used to verify device safety. No evidence of damage to the surrounding structures was noted from Sinus Balloon Catheter ostial dilation. This study was published in May of 2006 in the American Journal of Rhinology.

Initial Clinical Safety and Feasibility Study
Based on the positive pre-clinical study, a pilot study of 10 patients was conducted in Melbourne, Australia, to demonstrate safety and feasibility. Dr. Christopher Brown, an otolaryngologist with advanced fellowship training in Rhinology and Sinus Surgery, performed the study. Testing was conducted with Human Subjects/Ethics Committee approval. During the investigation, 18 Sinus Balloon Catheter dilations were performed. The Sinus Balloon Catheter successfully dilated the ostia without complications. Tissue trauma and bleeding with sinus balloon dilation was observed to be less than what normally is seen during standard sinus surgery. No post-surgical nasal packing was required. Post-operative examinations revealed that all patients tolerated Sinus Balloon Catheter dilation and no post-operative complications occurred. The ostial dilations achieved in surgery were maintained post-operatively. All patients healed well and observed sinus ostia remained patent. This study was published in April of 2006 in the Annals of Otology, Rhinology, and Laryngology.

CLEAR Study
In an ongoing effort to further confirm the safety and efficacy of the use of Balloon Sinuplasty™ devices, Acclarent, Inc. collaborated with thought leaders in the field of otolaryngology and conducted The CLinical Evaluation to Confirm SAfety and Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR) Study. This is an international, multi-center, non-randomized, prospective evaluation that further confirms safety and efficacy of the Balloon Sinuplasty™ devices using validated outcome measures. The CLEAR Study is designed to augment earlier pre-clinical studies and clinical data. Patient follow-up through 2 years has been completed. The one-year and two-year follow-up studies were published in the September supplement to Otolaryngology - Head and Neck Surgery, the official, peer-reviewed journal of the American Academy of Otolaryngology. Read more about the CLEAR Study.

Comparative Satisfaction, Pain, and Cost Study
This study assesses how use of Balloon Sinuplasty™ instruments during sinus surgery compares with using traditional rigid sinus surgery instrumentation with respect to symptom elimination, patient satisfaction, postoperative narcotic use, and cost. Data were collected on a group of 70 patients, half of which underwent sinus surgery using traditional instruments, and half of which used the Balloon Sinuplasty™ system. Results from the study showed that patient satisfaction and post-operative narcotic use for Balloon Sinuplasty™ patients compared favorably with traditional surgery. Additionally, cost of the Balloon Sinuplasty™ system in primary cases was similar to that of traditional FESS, but less for revision cases. This study was published in the March-April 2008 issue of American Journal of Rhinology.

PatiENT Registry Study
The PatiENT Registry Study assesses the safety and effectiveness of the Balloon Sinuplasty™system in a "real-world" setting. Data were collected by standardized chart review with centralized database administration for all consecutive functional endoscopic sinus surgeries that included the use of balloon catheters across the 18-month time periods from December2005 to May 2007, covering 1,036 patients across 27 practices. Balloon Sinuplasty™instruments were used in 3,276 peripheral sinuses. There were no major adverse events attributable to balloon catheter use. The revision rate was 1.3% of sinuses with an average follow-up of 40.2 weeks. Sinus symptoms improved in 95.2% of patients and 73.8% of patients were free of sinus infections in the follow-up period after treatment using the Balloon Sinuplasty™ system. The results of this study were published in the April 2008 issue of Annals of Otology, Rhinology & Laryngology.

Case Reviews
Review clinical case examples to learn more about the use of the Balloon Sinuplasty™ system.

Publications
Visit Publications to review our published, clinical studies.