Balloon Sinuplasty

What is Balloon Sinuplasty™?

Balloon Sinuplasty (BSP) is a safe and effective procedure for chronic sinusitis patients who are not responding well to medications and are seeking relief from uncomfortable and painful sinusitis symptoms.

With Balloon Sinuplasty , ENT doctors open inflamed sinuses in the same way that heart surgeons open up blocked arteries during balloon angioplasty. The procedure is less invasive than traditional sinus surgery, and effective at relieving symptoms of chronic sinusitis. Balloon Sinuplasty allows patients to return to normal activities quickly. Unlike conventional sinus surgery, it does not include removal of bone or tissue from the nose.

The benefits of Balloon Sinuplasty include:

Safe
More than 150,000 patients have been treated safely with Balloon Sinuplasty.
Proven
Over 95% of patients who’ve had the procedure say they would have it again. ⁽¹⁾
Fast
While recovery time varies with each patient, people can quickly return to normal activities. ⁽²⁾

If you have been diagnosed with chronic sinusitis and are not responding well to antibiotics, you may be a candidate for sinus surgery. There is now a less invasive option used by ENT doctors to treat chronic sinusitis that is clinically proven to be safe, effective and improve the quality of your life.

Sources

ORIOS I, office-based dilation, Data on file at Acclarent.
Wynn R, Vaughn W. “Post-Operative Pain After FESS with Balloon Sinuplasty .”AAO, 2006.

Balloon Sinuplasty™ In-Office

Balloon Sinuplasty is now available to eligible patients as a procedure performed in your doctor’s office, under local anesthesia. Your physician will recommend the best approach for you.

Benefits of Balloon Sinuplasty In-Office

Local Anesthesia
Balloon Sinuplasty In-Office is an option for patients who decline or are ineligible for general anesthesia.
Fast Recovery
While recovery time varies with each patient, most patients who undergo the in-office procedure can return to normal activities and work within 2 days. ¹
Comfortable Surroundings
Experience the procedure in the comfort of your physician’s office rather than a hospital operating room.
High Patient Satisfaction
100% percent of patients who had Balloon Sinuplasty In-Office would recommend the procedure to their family and friends. ²
Potential for Significant Cost Savings
Some eligible patients may have lower out-of-pocket costs if the procedure is performed in a lower cost of care setting, such as a physician office.

For more information
Contact us to learn more about this exciting new option for the treatment of your sinusitis symptoms.

Sources

ORIOS II. Data on file at Acclarent.
Albritton, F et al. Feasibility of in-office endoscopic sinus surgery with balloon sinus dilation. Am J Rhinol Allergy, 2012 (26): 1-6. (n=21).

Sinusitis Overview

Sinusitis affects 37 million people each year ^(1,2), making it one of the most common health problems in the U.S. It is more prevalent than heart disease and asthma and has a greater impact on quality of life than chronic back pain or congestive heart failure. ⁽³⁾

When you have acute or chronic sinusitis, the mucous membranes of your nose, sinuses and throat become inflamed, possibly from a pre-existing cold or allergies. Swelling obstructs the sinus openings and prevents normal mucus drainage, causing mucus and pressure to build up. Symptoms include: drainage of a thick, yellow or greenish discharge from the nose or down the back of the throat; nasal obstruction or congestion; tenderness and swelling around the eyes, cheeks, nose and forehead; and/or a reduced sense of smell and taste.

Types of Sinusitis

Many sinusitis cases are acute, but if sinusitis symptoms last longer than 12 weeks, it could be chronic sinusitis. Structural issues such as blockage of the sinus opening can also lead to chronic sinusitis.

A diagram of the human sinuses.

A Look into the Sinuses

The sinuses are hollow spaces in the skull (i.e. the frontal, ethmoid, sphenoid and maxillary) which serve to lighten the skull and give resonance to the voice. The purpose of the sinuses, which open into the nasal cavity, is to generate mucus to keep the nose from drying out during breathing and to trap unwanted materials so that they do not reach the lungs.

Each sinus has an opening that allows mucus to drain – this drainage is essential to keeping your sinuses working well and you healthy. Anything that obstructs that flow may cause a buildup of mucus and lead to a sinus infection.

Facts About Sinusitis

Sinusitis affects approximately 14% of the adult U.S. population. ⁽⁴⁾
Sinusitis affects 17% of women and 10% of men each year. ⁽⁴⁾
Chronic sinusitis (not including acute sinusitis) results annually in an estimated 7 million physician office visits. ^(1,5)
Direct healthcare expenditures due to sinusitis costs are well over $8 billion each year. ⁽⁶⁾
Total restricted activity days due to sinusitis are over 58 million per year. ⁽⁶⁾
Up to 60% of patients are not successfully treated with sinus medication. When medical management methods are not enough to relieve patients’ symptoms, sinus surgery may be recommended. ⁽⁷⁾

Sinusitis treatment includes medical and natural therapy, as well as sinus surgery. An Ear, Nose and Throat doctor (ENT doctor) can diagnose acute or chronic sinusitis and determine the best treatment plan.

Sources

Benninger, M. et al. Adult chronic rhinosinusitis: Definitions, diagnosis, epidemiology, and pathophysiology. Otolaryngol Head Neck Surg 2003; 129S: S1-S32.
Lusk R, Bothwell MR, Piccirillo J. Long-term follow-up for children treated with surgical intervention for chronic rhinosinusitis. Laryngoscope 2006; 116:(12) 2099-2107.
Gliklich RE, Metson R. The health impact of chronic sinusitis in patients seeking otolaryngologic care. Otolaryngol Head Neck Surg. 1995 Jul; 113(1):104-9.
Pleis JR, Lethbridge-Çejku M. Summary health statistics for U.S. adults: National Health Interview Survey, 2006. National Center for Health Statistics. Vital Health Stat 10(235). 2007.
Bhattacharyya N. Clinical and symptom criteria for the accurate diagnosis of chronic rhinosinusitis. Laryngoscope 2006; 116(Suppl 110):1-22
Ray, N., et al. Healthcare expenditures for sinusitis in 1996: Contributions of asthma, rhinitis, and other airway disorders. J Allergy Clin Immunol 1999; 103: 408-414. (Inflation Adjusted as per CPI to 2010 dollars.)
Hamilos, D. Chronic sinusitis. J Allergy Clin Immunol 2000; 106: 213-227; Stankiewicz, J., et al,. Cost Analysis in the Diagnosis of Chronic Rhinosinusitis. Am J Rhinol 2003;17(3): 139-142; Subramanian, H., et al. 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; Hessler, 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; Lal, D., et al. Efficacy of targeted medical therapy in chronic rhinosinusitis, and predictors of failure. Am J Rhinol Allergy 23, 396-400, 2009.

Answers to Your Sinusitis Questions

What is sinusitis?

Sinusitis is an inflammation of the sinus lining. If the sinus opening becomes blocked due to this swelling, normal mucus drainage may not occur, and this may lead to recurrent sinus infections and painful symptoms. Sinusitis can be acute, lasting for less than four weeks, or chronic, lasting longer than 12 weeks. When sinus symptoms last longer than 12 weeks, you should see an ENT doctor for a diagnosis.

What is the difference between chronic sinusitis and allergies or colds?

Sinusitis is often preceded by a cold or allergy attack. Colds and allergies can lead to inflamed sinuses, causing the sinus openings to become blocked. This prevents normal mucus drainage and can result in sinusitis.

What are the common symptoms of sinusitis?

Common symptoms of both acute and chronic sinusitis include: ^( 1 )

Facial pain
Tenderness and swelling around the eyes, cheeks, nose and forehead
Sinus pressure or congestion
Difficulty breathing through the nose
Loss of the sense of smell or taste
Sinus Headache
Yellow or green mucus from the nose
Teeth pain
Fatigue
Sore throat from nasal discharge
Bad breath

What types of doctors treat chronic sinusitis?

Many types of physicians including general and family practice physicians, pediatricians, and allergists may prescribe medication for sinusitis. However, if you have chronic sinusitis or if your symptoms do not improve with medication, you may be referred to an Ear, Nose, and Throat doctor (ENT doctor), or Otolaryngologist, who can discuss additional options to treat your chronic sinusitis.

How is sinusitis treated?

Sinusitis can be treated non-surgically with natural therapy such as inhaling steam or using saline nasal sprays, or ENT doctors can prescribe medications such as antibiotics or nasal steroid sprays. However, clinical studies show up to 60% of sinusitis sufferers do not get relief with medication. ^( 2 )For patients who do not respond adequately to medications, an ENT doctor may recommend sinus surgery.
Traditional sinus surgery removes bone and tissue to enlarge the sinus opening with the aim of clearing blocked sinuses and restoring normal sinus drainage. With this procedure, sinus surgery recovery is often associated with pain and scarring.
Balloon Sinuplasty is a breakthrough, minimally invasive procedure that ENT doctors use to treat chronic sinusitis. A tiny balloon is placed into the nose to reach the blocked sinuses and then inflated to restructure the sinus opening. The procedure is safe, effective and has a quick recovery. ^( 3 )

Is Balloon Sinuplasty cleared for use by the FDA?

Balloon Sinuplasty received FDA clearance in 2005. Over 150,000 patients have had the procedure.

Does Balloon Sinuplasty work?

Clinical research confirms that Balloon Sinuplasty provides long-term relief from sinus symptoms by effectively opening blocked sinus passageways. ^( 3 )

Is the effect of this procedure permanent or might I have to undergo repeated procedures?

How long your sinuses stay open depends on the extent of your sinus disease or other factors. It is unlikely that you would require repeat procedures, but the procedure may be repeated if your surgeon deems it necessary.

How many people have had the Balloon Sinuplasty procedure?

More than 150,000 people around the world have experienced Balloon Sinuplasty .

What are the advantages of the Balloon Sinuplasty over traditional sinus surgery?

Balloon Sinuplasty is less invasive than traditional surgery with minimal bleeding and low post-op pain. ^( 4, 6)Most people can get back to normal activities and work quickly.

How long does symptom relief last after Balloon Sinuplasty ?

Results vary by individual. A clinical study of 1,036 patients at multiple institutions reported that sinus symptoms improved in 95% of patients at an average follow-up period of 9 months. ^( 4 )In another study, patients reported symptom improvement up to two years after having the procedure. ^( 3 )

Is Balloon Sinuplasty safe?

Yes. Clinical studies have shown that Balloon Sinuplasty is safe, minimally invasive, and significantly improves quality of life. ^( 3 )

What material is the balloon made from?

The balloon is made from a type of plastic that does not contain latex.

What are the risks associated with Balloon Sinuplasty ?

Because Balloon Sinuplasty is less invasive than traditional sinus surgery there is a low complication rate. But there are some associated risks, including tissue and mucosal trauma, infection, or possible optic injury. Talk with your doctor about the risks and benefits and to determine whether Balloon Sinuplasty is right for you.

How long does the Balloon Sinuplasty procedure take?

Since the duration of the procedure varies, ask your healthcare provider for the most accurate answer. However, in a study of more than 1,000 patients, the average procedure time in the operating room was 73 minutes. ^( 4 )None of the patients required an overnight stay at the hospital.

Will I require general anesthesia during Balloon Sinuplasty ?

Most patients undergo general anesthesia, but an increasing number of ENT doctors perform the procedure in the office, under local anesthesia. Your healthcare provider can best advise you on your anesthesia options.

How long does it take to recover after Balloon Sinuplasty ?

Typically patients go home the same day that they have the procedure. While recovery time will vary from patient to patient, many people can quickly return to normal activities. ^( 5 )

Does Balloon Sinuplasty limit my future sinusitis treatment options?

No. Surgeons may use Balloon Sinuplasty with other medical therapies, and it does not limit future treatment options for patients.

Is Balloon Sinuplasty right for me?

It is important to talk to your ENT doctor about all of your sinus treatment options and ask what type of sinus therapy is best for you. If you suffer from chronic sinusitis, and sinus medications have not been effective in relieving your symptoms, you may be a candidate for Balloon Sinuplasty .

Can Balloon Sinuplasty be used in children?

Balloon Sinuplasty is a safe and effective option to relieve chronic sinusitis symptoms in children's maxillary sinuses.

How much does Balloon Sinuplasty cost?

Your cost will vary depending on your insurance coverage. Speak with your insurance company about the cost.

Is Balloon Sinuplasty covered by Medicare?

Yes. Medicare's sinus surgery insurance coverage includes Balloon Sinuplasty.

Is Balloon Sinuplasty covered by my insurance carrier?

To be certain of your sinus surgery insurance coverage, contact your insurance provider to find out your specific policy.

Sources

http://www.entnet.org/healthinformation/sinusitis.cfm Accessed July 19, 2011
Hamilos, D. Chronic sinusitis. J Allergy Clin Immunol 2000; 106: 213-227; Stankiewicz, J., et al,. Cost Analysis in the Diagnosis of Chronic Rhinosinusitis. Am J Rhinol 2003;17(3): 139-142; Subramanian, H., et al. 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; Hessler, 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; Lal, D., et al. Efficacy of targeted medical therapy in chronic rhinosinusitis, and predictors of failure. Am J Rhinol Allergy 23, 396-400, 2009.
Weiss, et al. "Long-term outcome analysis of balloon catheter sinusotomy: Two-year follow-up." Otolaryngology-Head and Neck Surgery, 2008, Vol. 139, pp. S38-S46.
Levine et al. Multicenter Registry of Balloon Catheter Sinusotomy Outcomes for 1,036 Patients, Annals of Otology, Rhinology, and Laryngology, 2008, Vol. 117, pp. 263-270.
Wynn R, Vaughn W. "Post-Operative Pain After FESS with Balloon Sinuplasty ."AAO, 2006.
Freidman, M. et al. Functional endoscopic dilatation of the sinuses: Patient satisfaction, postoperative pain, and cost. American Journal of Rhinology, March 2008, Vol. 22, pp. 204-209.