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 2008 supplement to Otolaryngology - Head and Neck Surgery, the official, peer-reviewed journal of the American Academy of Otolaryngology.
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 December 2005 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.
Completed in 2009, the ORIOS study compared standalone Balloon Sinuplasty in-office with traditional and hybrid FESS in the operating room. Acclarent, Inc. collaborated with thought leaders in the field of otolaryngology to study feasibility and cost of in-office endoscopic surgery with balloon dilation. This was a multicenter, prospective study covering 72 patients, with 37 patients undergoing In-Office Balloon-only sinus dilation and 35 patients undergoing hybrid / traditional FESS in the OR at physician discretion (patients were not randomized or matched for disease severity).
Participants reported similar improvement in SNOT-20 scores across treatment groups. In-office technical success was 89%. The study concluded that office-based ESS with BSD is feasible with high technical success rate, meaningful patient symptom improvement, and high patient satisfaction. The results of this study were published in the American Journal of Rhinology & Allergy. Read more here.
Building upon the original ORIOS study’s demonstration of feasibility, ORIOS 2 establishes the safety, radiographic and symptomatic efficacy of ACCLARENT® Balloon Sinuplasty System in the office setting with a robust sample. This prospective, multicenter study of 203 patients was first presented at the 2012 COSM.
Participants experienced statistically significant mean Lund‐MacKay score improvement at 24 weeks from 6.9 to 2.5 (p<0.0001) and statistically significant SNOT‐20 improvement at every time point. Dilation technical success rate was 93.2% (552 sinuses dilated /592 sinuses targeted). The majority of patients return to normal activity in 2 days or less. Additionally, 31 patients entered the study with mild‐to‐moderate ethmoid disease, with pre/post CTs available, and no ethmoidectomy during the study. The mean ethmoid-specific LMK dropped from 2.7 pre‐op to 0.7 at 24 weeks (out of total of 8), and 87.1% of patients showed radiographic improvement of ethmoid disease at 24 weeks. This study demonstrates that office based ESS with BSD is safe, feasible, well‐tolerated, and an effective option for patients whose prescribed surgical intervention does not necessitate general anesthesia. Read more here.
Balloon Dilation of the Frontal Recess: A Randomized Clinical Trial (PLAZA Study)
This study published by Dr. Plaza et al. in the Annals of Otology, Rhinology, and Laryngology in 2011 was the first double-blind prospective randomized clinical trial comparing FESS with BSP vs. traditional FESS alone in the frontal sinuses. The study was conducted independent of Acclarent, Inc. at a University Hospital in Spain.
40 participants were enrolled, 34 were randomized, and 32 completed a 1 year follow up. All patients had frontal disease with nasal polyposis & total opacification of at least one frontal sinus. These were highly diseased patients who previously failed intensive medical therapy. The ACCLARENT Balloon Catheter used was a 5x16 RELIEVA® Balloon for all BSP (Balloon Sinuplasty) patients, with fluoroscopy. Outcome measures included endoscopic visualization of the frontal recess and CT scores of the frontal sinus (Lund-Mackay scores).
The results showed an 81% successful BSP dilation rate (failures were due to osteitis and extensive polyposis) and a 92% technical success rate for FESS. In both groups there was a statistically significant reduction in Lund-Mackay scores and improved symptom scores, polyposis scores, and RDSI (Rhinosinusitis Disability Index) scores between baseline and final measurements. BSP showed 81% resolution of frontal disease vs. 75% resolution with FESS (NS). Endoscopic permeability or patency of the frontal recess was more frequent after balloon dilation (BSP at 73% vs. conventional FESS at 63%, NS). No major complications were observed with 1 patient in the BSP arm requiring revision (6%) vs. 3 patients in the FESS arm (19%, NS). The authors of the paper conclude that balloon dilation of the frontal recess is a relatively safe and effective tool in the management of CRS of the frontal sinus after failed intensive medical treatment, and with less morbidity than after conventional FESS. In addition, frontal Balloon Sinuplasty can be used in cases of CRS with polyps as a hybrid procedures with rates of success similar to those in patients without polyps.
Balloon Catheter Sinuplasty in Young Children (INTACT study)1
This study was published by Dr. Ramadan et al. in the American Journal of Rhinology and Allergy in 2010 . It was a multi-center, prospective study with 32 children aged 2-11 receiving Balloon Sinuplasty (BSP). Follow-ups were done at 1, 12, 24, and 52 weeks. The endpoints included safety at the time of surgery and outcomes evaluated using the clinically validated SN-5 test which assesses symptom burden.
The results demonstrated that mean SN-5 scores decreased from 4.9 at baseline to 2.95 at 52 week follow-up representing a clinically and statistically significant 40% reduction in symptom burden. There were 0 adverse events and 87% of patients showed sustained improvement in the SN-5 score at 1 year follow-up. The authors concluded that sinus ostial dilation using BSP technology in children may be an effective minimally invasive treatment option to relieve sinus ostial obstruction in the maxillary sinus, and improve patient quality of life.
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1ACCLARENT Balloon Sinuplasty is indicated for the dilation of pediatric maxillary sinuses. This study also included limited use of products in the frontal and sphenoid sinuses. Clinical Success indicated as defined by studies.