IRVINE, Calif., Sept. 6, 2016 /PRNewswire/ -- Acclarent, Inc., announced results today from a study published in the American Journal of Rhinology & Allergy evaluating clinical outcomes of Balloon Sinuplasty (BSP) technology versus continued medical management. This is the first prospective, multi-center study comparing the two treatments. The study showed that chronic rhinosinusitis (CRS) patients who opted for surgery with BSP technology showed significantly greater improvements in quality of life and less nasal steroid use, compared to those who elected continued medical management.
In addition, the data confirmed that BSP as a standalone procedure in the office provided superior outcomes compared to continued medical management. In that subset of patients, whose disease was appropriate to be treated in the office, nearly half returned to normal activity within one day after surgery.
"We finally have high-level evidence that for sufferers of chronic sinusitis, balloon dilation of the sinuses does a better job of improving quality of life than just staying on medications," said Dr. Spencer Payne, Director of Rhinology & Sinus Surgery at the University of Virginia.
Sinusitis is one of the most common chronic health problems in the United States, affecting approximately 37 million people each year. Those with chronic sinusitis typically suffer from a combination of headaches, congestion, facial pain/pressure, and other symptoms impacting their physical, functional and emotional quality of life.1
While the condition is typically treated first with medication, at least 20 percent of people do not respond adequately to such treatment.2,3 In these cases, BSP technology – a safe and minimally-invasive alternative that widens the sinus openings – may be an option.4,5
"As first to market with BSP technology, we are focused on driving meaningful advancements in the ear, nose and throat space," said Dr. William Kane, Medical Director at Acclarent. "This study demonstrates some of the benefits of BSP versus continued medical management, showcasing our commitment to technology that helps relieve people's suffering as effectively as possible."
About the Acclarent BSP Technology vs. Continued Medical Management Study
The study included 198 adult patients across 24 centers in the United States. Enrolled patients were diagnosed with CRS and failed medical management. In the study, 146 patients chose BSP versus 52 who opted for continued medical management; of the patients who chose surgery, 72 percent (105/146) had an in-office procedure.
The primary end point was the relative between group difference in baseline to 24-week improvement in the Chronic Sinusitis Survey (CSS) scores; the secondary end points included the relative between group difference in scores (BSP versus medical management) of the SNOT-20 survey (measures disease-specific QOL) and Rhinosinusitis Disability Index (measures physical, emotional and functional effects of CRS).
The study found that after a 24-week follow-up, patients who opted for surgery with BSP technology demonstrated significantly greater improvements in quality of life versus those who chose continued medical management.
About Acclarent, Inc.
Acclarent, Inc., part of the Johnson & Johnson Medical Device Companies, is located in Irvine, CA. Its singular focus is to free patients to live better lives by designing, developing and commercializing medical devices that address conditions affecting the ear, nose, and throat. For more than a decade, Acclarent has led the field in delivering innovative Balloon Sinuplasty technologies to ENT surgeons who manage patients with chronic sinusitis. For more information, visit www.acclarent.com.
For Physicians: Acclarent® Devices are intended for use by or under the direction of a physician who is trained in the use of Acclarent® Technology. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions associated with these devices, as well as all products mentioned on this webpage.
For Patients: Acclarent® Technology is intended for use by or under the direction of a physician. Acclarent® Technology has associated risks, including tissue and mucosal trauma, infection, or possible optic injury. Consult your physician for a full discussion of risks and benefits to determine whether this procedure is right for you.
1 Benninger, M. Adult chronic rhinosinusitis: Definitions, diagnosis, epidemiology, and pathophysiology. Otolaryngol Head Neck Surg 2003;129S:S1-S32.
2 Hessler J, Piccirillo J, et al. Clinical outcomes of chronic rhinosinusitis in response to medical therapy: Results of a prospective study. Am J Rhinol. 2007;21(1):10-18.
3 Lal D, Scianna J, et al. Efficacy of targeted medical therapy in chronic rhinosinusitis, and predictors of failure. Am J Rhinol Allergy. 23, 396-400, 2009.
4 Bolger WE, Brown CL, Church CA, et al. Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 patients. Otolaryngol Head Neck Surg. 2007;137(1):10-20.
5 Weiss RL, Church CA, Kuhn FA, et al. Long-term outcome analysis of balloon catheter sinusotomy: two-year follow-up. Otolaryngol Head Neck Surg. 2008:139(3 Suppl 3):S38-46.
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SOURCE Acclarent, Inc.