Sinusitis affects 37 million people each year,1,2,3 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 quality of life than chronic back pain or congestive heart failure.4 Sinusitis is also responsible for $8 billion*5 in direct healthcare expenditures and a significant loss of workplace productivity.6
Sinusitis is defined as an inflammation of the sinus lining commonly caused by bacterial and / or viral infections; as well as, structural issues such as ostial blockage. Symptoms include nasal congestion, facial discomfort, nasal discharge, headache, and fatigue. Sinusitis is considered acute when symptoms last 4 weeks or less. The disease is considered chronic when it lasts 12 weeks or longer.
The most frequently used treatments are medications and / or Functional Endoscopic Sinus Surgery (FESS). Treatment with antibiotics or topical nasal steroid spray is often successful in reducing mucosal swelling and relieving obstructions within the sinus ostium and ostio-meatal region. However, at least 20% of patients do not respond adequately to medications.7,8,9,10
For these patients, surgery is often their next step toward finding relief. The goals of sinus surgery are to clear blocked sinuses, restore normal sinus drainage and function, while preserving normal anatomy and mucosal tissue. Currently with FESS, specialized probes are used to cannulate closed ostia, and small forceps are used to resect periostial bone and tissue to enlarge the sinus ostia. Removal of bone and tissue may lead to post-operative pain, scarring, and bleeding. Nasal packing may be required to control the bleeding. Annually approximately 500,000 FESS procedures are performed.11,12,13
A significant unmet clinical need.
Every year approximately 900,000 patients are left living with their sinus condition.14 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 FESS 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 and may be used with other medical therapies or FESS techniques. Read more about the Balloon Sinuplasty technology.
* Inflation Adjusted
1. National Health Interview Survey, 2006.
2. US Census 2007.
3. Lusk, R., et al, Laryngoscope 2006; 116: 2099-2107.
4. Gliklich, R., et al, J Allergy Clin Immunol 1999; 113: 104-109.
5. Ray, N., et al, J Allergy Clin Immunol 1999; 103: 408-414.
6. Collins, J., Vital Health Stat 1997; 10: 1-89.
7. Hamilos, D., J Allergy Clin Immunol 2000; 106: 213-227.
8. Stankiewicz, J., et al, Am J Rhinol 2003; 17(3): 139-142.
9. Subramanian, H., et al, Am J Rhinol 2002; 16(6): 303-312.
10. Hessler, J., et al, Am J Rhinol 2007; 21(1): 10-18.
11. Millenium Research Group, USENT08, 2008.
12. Medtech Insight, A600, 2002.
13. Medtech Insight, A566, 2005.
14. Acclarent, Inc. estimates based on National Health Interview Survey, 2006; US Census 2007; Lusk, R., et al, Laryngoscope 2006; 116: 2099-2107; Hamilos, D., J Allergy Clin Immunol 2000; 106: 213-227; Stankiewicz, J., et al, Am J Rhinol 2003; 17(3): 139-142; Subramanian, H., et al, Am J Rhinol 2002; 16(6): 303-312; Hessler, J., et al, Am J Rhinol 2007; 21(1): 10-18; Millenium Research Group, USENT08, 2008; Medtech Insight, A600, 2002; Medtech Insight, A566, 2005.