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Sinusitis affects 35 million people each year (inflation adjusted),1 making it one of the most common health problems in the U.S. It is more prevalent than heart disease and asthma1 and has a greater impact on one’s quality of life than chronic back pain or congestive heart failure.2
Sinusitis is defined as an inflammation of the sinus lining, and is commonly caused by structural issues such as ostial blockage, bacterial infections, viral infections or a combination of these. For many patients, symptoms vary and may include nasal congestion, facial discomfort, nasal discharge, headache and fatigue. Sinusitis is considered acute when symptoms last 4 weeks or less and chronic when it lasts 12 weeks or longer.3
The most common treatments for sinusitis aim to reduce mucosal swelling and relieve obstructions within the sinus ostium and ostio-meatal region, and include:
• Medical therapy with antibiotics
• Topical nasal steroid spray
However, at least 20 percent of patients do not respond adequately to medications.4-6
For patients who have failed medical therapy, Endoscopic Sinus Surgery (ESS) is often the next step toward finding relief. During ESS, surgical instruments are used to remove small amounts of bone, tissue or growth blocking the sinus openings. Often, this removal of bone and tissue can require uncomfortable nasal packing after surgery and lead to post-surgery pain and scarring.
A Significant Unmet Clinical Need
Each year approximately 1,250,000 patients are left living with their sinus condition.6-9 These patients may not find adequate relief from medical therapy and are candidates for surgery, but for a variety of clinical or personal reasons choose not to undergo ESS using existing surgical instruments.
Balloon Sinuplasty Technology: Novel, Endoscopic, Catheter-Based Devices
Balloon Sinuplasty products are endoscopic, catheter-based devices used to dilate blocked paranasal sinus ostia. These devices are endoscopic tools that may be used with other medical therapies or ESS techniques. Learn more about the Balloon Sinuplasty technology.
Balloon Sinuplasty technology contributes to the sinus surgery evolution by offering a surgeon additional tools for endoscopic surgery. The RELIEVA® Balloon Sinuplasty products are catheter-based devices designed to assist Otolaryngologists in further meeting their surgical goals of clearing blocked sinuses, restoring normal sinus drainage and function, and preserving normal anatomy and mucosal tissue.
Balloon Sinuplasty In-Office
Office-based sinus dilation may be a compelling option for patients who decline or are ineligible for traditional OR-based surgery.
1. Benninger, M. et al. Adult chronic rhinosinusitis: Definitions, diagnosis, epidemiology, and pathophysiology. Otolaryngology Head Neck Surg 2003; 129S: S1-S32.
2. Gliklich, R., et al. Health impact of chronic sinusitis in patients seeking otolaryngologic care. Journal of Allergy and Clinical Immunology 1995; 113: 104-109.
3. Sinusitis - Patient Health Information. American Academy of Otolaryngology - Head and Neck Surgery. 2016. http://www.entnet.org/content/sinusitis.
4. Stankiewicz, J., et al. Cost analysis in the diagnosis of chronic rhinosinusitis. American Journal of Rhinology 2003; 17(3): 139-142.
5. Subramanian, H., et al. A retrospective analysis of treatment outcomes and time to relapse after intensive medical treatment for CRS. American Journal of Rhinology 2002; 16(6): 303-312.
6. Rosenfeld, R.M., Piccirillo, J.F., Chandrasekhar, S.S., et al. (2015), Clinical Practice Guideline (Update): Adult Sinusitis, Otolaryngology - Head and Neck Surgery, 152(25): S1-S39.
7. National Ambulatory Medical Care Survey: 2009 Summary Tables Table 13 (CDC)
8. Lal, D., Scianna, J., Stankiewicz, J. (2009). Efficacy of Targeted Medical Therapy in Chronic Rhinosinusitis, and Predicators of Failure. Am J Rhinol (21): 11-18.
9. Hessler, J., et al. Clinical outcomes of chronic rhinosinusitis in response to medical therapy: Results of a prospective study. American Journal of Rhinolology 2007; 21(1): 10-18.
ACCLARENT RELIEVA® 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. 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 resource.
RELIEVA SPINPLUS® Balloon Sinuplasty System and RELIEVA ULTIRRA® Sinus Balloon Catheter are indicated for dilation of maxillary sinuses in children 17 and younger. All referenced studies below included limited use of the devices in frontal and sphenoid sinuses, for which the safety and effectiveness for children 17 and under has not been established.
Acclarent Devices are intended for use by or under the direction of a physician who is trained in the use of Acclarent Technology. INSPIRA AIR® Balloon Dilation System use has described risks, including serious complications such as airway obstruction, airway rupture (partial or complete) resulting in pneumomediastinum, pneumothorax and mediastinitis, chest pain, bronchospasm, atelectasis, pulmonary edema and bleeding. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions associated with these devices.
The RELIEVA CIRCA® Ethmoid Punch is an instrument for the excision of bone and soft tissue in the ethmoid sinus in adults, and is intended for use by or under the direction of a physician with experience in sinus surgery. The RELIEVA CIRCA® Ethmoid Punch use has described risks including unintended tissue trauma, bleeding and infection. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings and precautions described for this device.
ACCLARENT® ENT 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. 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 system.
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.
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.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
This site is published by Acclarent, Inc. which is solely responsible for its contents. It is intended for visitors from the United States.
© Acclarent, Inc. 2019. Last Updated on November 15, 2018.