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Acclarent Launches A Complete Balloon Sinuplasty System For Children Who Suffer From Chronic Sinusitis

Acclarent, Inc. announced today the U.S. availability of the Relieva ® Spin Balloon Sinuplasty System with the M-110C Sinus Guide Catheter Tip designed to access small and tight sinus anatomy in children and adults. This innovation represents a new addition to Acclarent’s Balloon Sinuplasty portfolio, which physicians use to treat children who suffer from chronic maxillary sinusitis.

Balloon Sinuplasty Technology is a safe and minimally invasive system that widens the sinus openings of patients suffering from chronic sinusitis. This technology, used by ear, nose and throat (ENT) surgeons to treat patients with chronic sinusitis, has an excellent safety profile and is an effective treatment for blocked sinuses. 3,4,5,6,7

Sinusitis is one of the most common chronic health problems in the U.S., with 18 million office visits per year for chronic sinusitis. 1,2 Patients with chronic rhinosinusitis typically suffer from a combination of headaches, congestion, facial pain/pressure, and other symptoms impacting their physical, functional, and emotional quality of life. While chronic sinusitis is typically treated first with medication, at least 20 percent of patients do not respond adequately to such treatment. 8,9,10 For children suffering from this condition, it can result is considerable loss of school time and accumulation of medical expenses. 11

“As the leader in Balloon Sinuplasty technology, Acclarent is pleased to offer the Relieva ® Spin Balloon Sinuplasty System for children who suffer from chronic maxillary sinusitis,” said Dr. Howard Levine, otolaryngologist and Acclarent Vice President of Clinical and Medical Affairs. “Our Balloon technology has been used in over 300,000 adults and children who suffer from chronic sinusitis and this launch continues to support Acclarent’s mission to provide sinus relief to children as well.” 12

The Relieva ® Spin Balloon Sinuplasty System provides a means to access the sinus space and to dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, Relieva ® Spin Balloon Sinuplasty System is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures. The new Relieva ® Spin M-110C sinus guide catheter tip is designed to work with the existing Relieva ® Spin Balloon Sinuplasty System portfolio, and to access small and tight anatomy.

“The Relieva ® Spin Balloon Sinuplasty System is a single-handed system to access and dilate sinus cavities and offers flexible over-the-wire technology,” said Dr. Eric Waki, pediatric otolaryngologist. “The product’s design allows me to effectively treat all different types of patients, including adults and children with small anatomy.”

About Acclarent, Inc.

Acclarent, Inc., a business unit of Johnson & Johnson, is a medical device company located in Menlo Park, 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 (ENT). For more information, visit www.acclarent.com or www.BalloonSinuplasty.com.

Dr. Waki is compensated for his services as a member of the company’s Speakers Bureau and provides other consulting services.

1   Benninger, M. Adult chronic rhinosinusitis: Definitions, diagnosis, epidemiology, and pathophysiology. Otolaryngol Head Neck Surg 2003;129S:S1-S32.

2

Schiller JS, Lucas JW, Ward BW, Peregoy JA. Summary health statistics for U.S. adults: National Health Interview Survey, 2010. National Center for Health.
3 Bolger W, Brown CL, 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.
4 Levine HL, Sertich AP, et al. Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients. Ann Otol Rhinol Laryngol. 2008;117(4):263-270.
5 Karanfilov B, Silvers S, et al. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol. 2012;Nov 7. doi:10.1002/alr.21112.
6 Ramadan HH, McLaughlin K, et al. Balloon Catheter Sinuplasty in Young Children. American Journal of Rhinologya nd Allergy, 2010; 24(1):e54-e56
7 Ramadan HH, Terrell AM. Balloon catheter sinuplasty and adenoidectomy in children with chronic rhinosinusitis. Annalys of Otology, Rhinology & Laryngology, 2010; 119(9):578-582.
8 Subramanian H, Schechtman, K. A Retrospective Analysis of Treatment Outcomes and Time to Relapse after Intensive Medical Treatment for Chronic Sinusitis. Am J Rhinol. 2002;16(6):303-312.
9 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.
10 Lal D, Scianna J, et al. Effi cacy of targeted medical therapy in chronic rhinosinusitis, and predictors of failure. Am J Rhinol Allergy. 23, 396-400, 2009.
11 Kay DJ, Rosenfeld RM. Quality of life for children with persistent sinonasal symptoms. Otolaryngol Head Neck Surg 2003;128:17- 26.
12 Acclarent Data on File, #10




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