Acclarent, Inc. recently announced the U.S. launch of the RELIEVA SpinPlus Balloon Sinuplasty System, now with integrated irrigation to enable lavage of the target sinus. In addition to the precise, single-handed control of sinus access and dilation that RELIEVA Spin provided, the new distal jet integration into the tip of the balloon catheter irrigates to clean sinus contents with increased coverage.  “Deep intra-sinus irrigation would allow me the potential to reduce bacteria and biofilms from the sinus, which is critical to achieving meaningful patient outcomes,” said Troy Woodard, MD, Rhinologist for Cleveland Clinic’s Head and Neck Institute.

The RELIEVA SpinPlus Balloon Sinuplasty System has several new features and enhancements allowing increased accuracy and mobility during the procedure. These features include:

• One-time sinus access for confirmation, dilation and irrigation
• Ability to independently advance or retract integrated wire and balloon for greater navigation flexibility
• Re-sized and re-shaped design offering an ergonomic fit for a variety of users
• Designed for brighter light output

“The RELIEVA SpinPlus Balloon Sinuplasty System underscores Acclarent’s ongoing innovation and leadership within the ENT space,” said Dr. John Canady, Vice President, Franchise Medical Affairs for Acclarent. “We are pleased to add this next-generation technology to our full suite of services to treat patients with chronic sinusitis more efficiently than ever before.”

Balloon Sinuplasty Technology is a safe and minimally invasive system that widens the sinus openings of patients suffering from chronic sinusitis.^1,2 The RELIEVA SpinPlus Balloon Sinuplasty System utilizes this technology to advance a flexible, over-the-wire balloon system into the sinus that enables surgeons to perform an atraumatic procedure protecting the patient’s natural anatomy.

Sinusitis is one of the most common chronic health problems in the U.S., with 18 million office visits per year attributed to chronic sinusitis. Patients 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.³ While chronic sinusitis is typically treated first with medication, at least 20 percent of patients do not respond adequately to such treatment.^4,5

Acclarent, Inc. is committed to delivering the latest technologies to ENT physicians.  In 2005, Acclarent pioneered Balloon Sinus Dilation (Balloon Sinuplasty) and continues to be the market leader in this category with a variety of devices for Sinus Dilation.  This procedure is now performed in Hospitals, Surgery Centers, and select In-Offices.

Many ENTs perform Balloon Sinuplasty in their offices using local anesthesia. This may be an option for patients who want relief from chronic sinusitis symptoms and would prefer to avoid the stress and hassle of a hospital operating room procedure.

Device flexibility matters.  Not all Balloon Sinus Dilation devices are the same.  Acclarent Balloon Sinuplasty devices offer unsurpassed reach and flexibility.  Challenges in CRS management include highly complex frontal and variable maxillary sinus anatomy.^6,7

Acclarent
www.acclarent.com

[1] 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.

[2] 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.

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

[4] 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.

[5] 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.

[6] Dearking AC, Pallanch JF. Mapping the frontal sinus ostia using virtual endoscopy Laryngoscope 2012;122(10):2143-2147.

[7] Sikand A. Computed tomography-based exploration of infundibular anatomy for maxillary sinus balloon dilation. Ann Otol Rhinol Laryngol. 2011;120(10):656-662.