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The clinical evidence to support Acclarent, Inc.'s Balloon Sinuplasty System is covered in numerous clinical publications. Please see the following examples below.
The following are several clinical summaries relating to the clinical application of Acclarent’s innovative technologies. To view the list of publications, read more here.
CLEAR Study: Safety and Efficacy of Balloon Sinuplasty
Acclarent collaborated 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. This was an international, multi-center, non-randomized, prospective evaluation of the safety and efficacy of the Balloon Sinuplasty devices. The CLEAR Study was designed to augment earlier pre-clinical studies and clinical data. Patient follow-up through two 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.
ORIOS Study: Balloon Sinuplasty In-Office Safety Feasibility
Completed in 2009, the ORIOS study evaluated the feasibility of in-office endoscopic surgery with balloon dilation and compared standalone Balloon Sinuplasty In-Office with traditional and hybrid ESS in the operating room. This was a multicenter, prospective study covering 72 patients, with 37 patients undergoing Balloon-only sinus dilation in-office and 35 patients undergoing hybrid / traditional ESS 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%.1
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.1
ORIOS 2 Study: Balloon Sinuplasty In-Office Safety, Effectiveness and Tolerability
Building upon the original ORIOS study’s demonstration of feasibility, ORIOS 2 establishes the safety, radiographic and symptomatic efficacy of Acclarent’s Balloon Sinuplasty System in the office setting with a robust sample. This prospective, multicenter study of 203 patients was first presented at the 2012 Combined Otolaryngological Spring Meetings (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.2
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. A larger subgroup of 61 patients with ethmoid disease was evaluated at 52+ weeks. The quality of life (QOL) for this subgroup had similar QOL improvement as those patients without ethmoid disease and only 13.1% of the ethmoid subgroup needed revisions.2
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.2
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 ESS with Balloon Sinuplasty (BSP) vs. traditional ESS alone in the frontal sinuses. The study was conducted independent of Acclarent at a University Hospital in Spain.
40 participants were enrolled, 34 were randomized, and 32 completed a one-year follow up. All patients had frontal disease with nasal polyposis and 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 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 ESS. 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 sinus disease vs. 75% resolution with ESS (NS) as confirmed by computed tomographic scan. Endoscopic permeability or patency of the frontal recess was more frequent after balloon dilation. Of those sinuses attempted to be treated, patency at 12-month follow-up for ESS and BSD was 15/24 (63%) and 19/26 (73%, NS), respectively. Of those sinuses actually treated, patency at 12-month follow-up for ESS and BSD was 15/22 (68%) and 19/21 (90%, p<0.05), respectively. No major complications were observed with one patient in the BSP arm requiring revision (6%) vs. three patients in the ESS arm (19%, NS).3
The authors of the paper conclude that balloon dilation of the frontal recess is a safe and effective tool in the management of chronic rhinosinusitis (CRS) of the frontal sinus after failed intensive medical treatment, and with less morbidity than after conventional ESS. In addition, frontal BSP can be used in cases of CRS with polyps as a hybrid procedure with rates of success similar to those in patients without polyps.3
Balloon Catheter Sinuplasty and Adenoidectomy in Children with Chronic Rhinosinusitis
This study published by Drs. Ramadan and Terrell in The Annals of Otology, Rhinology, and Laryngology was a non-randomized, controlled, prospective review of children with failed medical management of chronic rhinosinusitis (CRS) who underwent Balloon Sinuplasty and adenoidectomy or adenoidectomy alone. The study was conducted independent of Acclarent.
Forty-nine children met the inclusion criteria and 30 children age 4-11 years (mean 7.7 years) had Balloon Sinuplasty. Outcomes were assessed at 1 year of follow-up and were based on SN-5 scores and the need for revision surgery.
The mean Lund-Mackay score was 7.5. 24 of the 30 patients (80%) who underwent Balloon Catheter Sinuplasty (BCS) and adenoidectomy showed improvement of their symptoms after 12 months of follow-up, compared with 10 of the 19 patients (52.6%) who underwent adenoidectomy alone (p < 0.05).4
Patients were not randomized between the Balloon Sinuplasty and Adenoidectomy group and the adenoidectomy alone group. Therefore, the results may be due to different patient characteristics rather than the procedure performed.
For the treatment of pediatric CRS, Balloon Sinuplasty has been shown to be safe and effective in addressing symptoms of CRS.4
*Acclarent's Balloon Sinuplasty Systems (RELIEVA® Spin Balloon Sinuplasty System and RELIEVA ULTIRRA® Sinus Balloon Catheter) are indicated for children aged 17 and under and are intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.
The following are clinical publications relating to the clinical application of Acclarent, Inc.'s innovative technologies.
Endoscopic Dilation Sinus Surgery (FEDS) Versus Functional Endoscopic Sinus Surgery (ESS) for Treatment of Chronic Rhinosinusitis: A Pilot Study. Achar P, Duvvi S, Kumar BN. Acta Otorhinolaryngol Ital 2012 Oct;32(5):314-9
Standalone Balloon Dilation Versus Sinus Surgery for Chronic Rhinosinusitis: A Prospective, Multicenter, Randomized, Controlled Trial with 1-Year Follow-Up. Bikhazi N, Light J, Truitt T, Schwartz M, Cutler J. Am J Rhinol Allergy 2014;28:1-8
The Role of Balloon Sinuplasty in the Treatment of Sinus Headache. Marzetti A, Tedaldi M, Passali FM. Otolaryngologia Polska (2013)
Balloon Dilation of the Frontal Recess: A Randomized Clinical Trial. Plaza G, Eisenberg G, Montojo J, et al. Ann Otol Rhinol Laryngol 2011 Aug;120(8):511-8.
Balloon Sinuplasty In-Office
Feasibility of In-Office Endoscopic Sinus Surgery with Balloon Sinus Dilation. Albritton FD, Casiano RR, Sillers MJ. Am J Rhinol Allergy 2012 May;26(3):243-8
Office-Based Balloon Sinus Dilation: A Prospective, Multicenter Study of 203 Patients. Karanfilov B, Silvers S, Pasha R, et al. Int Forum Allergy Rhinol 2013 May;3(5):404-11
Introduction to an Office-Based Sinus Surgery Technique. Sikand A. Operative Techniques in Otolaryngology- Head and Neck Surgery 2011 Sep;22(3):246-52
In-Office Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis Utilizing Balloon Catheter Dilation Technology. Sillers MJ, Melroy CT. Curr Opin Otolaryngol Head Neck Surg 2013 Feb;21(1):17-22
Practical Techniques in Office-Based Balloon Sinus Dilation. Silvers SL. Operative Techniques In Otolaryngology - Head and Neck Surgery 2014;25(2):206-12
General Balloon Sinuplasty
Catheter-Based Dilation of the Sinus Ostia: Initial Safety and Feasibility Analysis in a Cadaver Model. Bolger WE, Vaughan WC. Am J Rhinol 2006 May;20(3):290-4
Safety and Outcomes of Balloon Catheter Sinusotomy: a Multicenter 24-Week Analysis in 115 Patients. Bolger WE, Brown CL, Church CA, et al. Otolaryngol Head Neck Surg 2007 Jul;137(1):10-20
Safety and Feasibility of Balloon Catheter Dilation of Paranasal Sinus Ostia: A Preliminary Investigation. Brown CL, Bolger WE. Ann Otol Rhinol Laryngol 2006 Apr;115(4):293-9
Functional Endoscopic Dilatation of the Sinuses: Patient Satisfaction, Postoperative Pain, and Cost. Friedman M, Schalch P, Lin HC, et al. Am J Rhinol 2008 Mar;22(2):204-9
Balloon Catheter Sinusotomy: One-Year Follow-up Outcomes and Role in Functional Endoscopic Sinus Surgery. Kuhn FA, Church CA, Goldberg AN, et al. Otolaryngol Head Neck Surg 2008 Sep;139 (3 Suppl 3):S27-S37
Multicenter Registry of Balloon Catheter Sinusotomy Outcomes for 1,036 Patients.Levine HL, Sertich AP, Hoisington DR, et al. Ann Otol Rhinol Laryngol 2008 Apr;117(4):263 70
Long-term Outcome Analysis of Balloon Catheter Sinusotomy: Two Year Follow-Up.Weiss RL, Church CA, Kuhn FA, et al. Otolaryngol Head Neck Surg 2008 Sep;139(3 Suppl 3):S38-S46
Pediatric Balloon Sinuplasty
*Safety and Feasibility of Balloon Sinuplasty for Treatment of Chronic Rhinosinusitis in Children. Ramadan HH. Ann Otol Rhinol Laryngol 2009 Mar;118(3):161-5
*Balloon Catheter Sinuplasty and Adenoidectomy in Children with Chronic Rhinosinusitis. Ramadan HH, Terrell AM. Ann Otol Rhinol Laryngol 2010 Sep;119(9):578-82
*Balloon Catheter Sinuplasty in Young Children. Ramadan HH, McLaughlin K, Josephson G, et al. Am J Rhinol Allergy 2010 Jan;24(1):e54-e56
Sinus Balloon Catheter Dilation after Adenoidectomy Failure for Children with Chronic Rhinosinusitis. Ramadan HH, Bueller H, Hester ST, et al. Arch Otolaryngol Head Neck Surg 2012 Jul;138(7):635-7
*Functional Endoscopic Sinus Surgery (ESS) Alone Versus Balloon Catheter Sinuplasty (BCS) and Ethmoidectomy: a Comparative Outcome Analysis in Pediatric Chronic Rhinosinusitis. Thottam PJ, Haupert M, Saraiya S, et al. Int J Pediatr Otorhinolaryngol 2012 Sep;76(9):1355-60
1. Albritton, F et al. (2012). Feasibility of In-Office Endoscopic Sinus Surgery with Balloon Sinus Dilation." Am J Rhinol Allergy. 26: 1-6
2. Karanfilov B, Silvers S, Pasha R, et al. (2013). Office-Based Balloon Sinus Dilation: A Prospective, Multicenter Study of 203 Patients. Int Forum Allergy Rhinol. 3(5):404-411
3. Plaza G, Eisenberg G, Montojo J, et al. (2011 Aug). Balloon Dilation of the Frontal Recess: A Randomized Clinical Trial. Ann Otol Rhinol Laryngol. 120(8):511-8
4. Ramadan HH, Terrell AM. (2010 Sep). Balloon Catheter Sinuplasty and Adenoidectomy in Children with Chronic Rhinosinusitis. Ann Otol Rhinol Laryngol. 119(9):578-82
Acclarent Navigation Technology is intended for use by or under the direction of a physician. Devices guided by the Acclarent Navigation Technology have described risks including the potential for unintended injury to the orbits or CNS as a consequence of inaccurate navigation.
ACCLARENT AERA® Eustachian Tube Balloon Dilation System is intended for use by physicians who are trained on Acclarent Technology. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury.
ACCLARENT® Balloon Sinuplasty Devices are intended for use by or under the direction of a physician who is trained in the use of Acclarent Technology. ACCLARENT® Balloon Sinuplasty Device use has described risks, including tissue and mucosal trauma, infection, or possible orbital injury.
The RELIEVA TRACT™ Nasal Balloon Dilation System is an instrument intended to provide increased intranasal space to facilitate access for endonasal and trans-nasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum. The RELIEVA TRACT™ Nasal Balloon Dilation System is intended for use in ages 17 years or older. Balloon dilation catheters should be used by or under supervision of physicians thoroughly trained in balloon dilation. A thorough understanding of the technical principles, clinical application, and risk associated with balloon dilation of the nasal passage is necessary before using this device.
Important Safety Information
Prior to use, it is important to read the Instructions for Use and to understand the registration process and the contraindications, warnings and precautions described for the systems.
Caution: Federal (US) law restricts the sale, distribution or use of these devices to, by or on the order of a physician. Third party trademarks used herein are trademarks of their respective owners. This content is intended for audience within the US only.
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© Acclarent, Inc. 2019. Last Updated on 11/18/2019