With the introduction of a novel, endoscopic, catheter-based technology called the Balloon Sinuplasty™ system, there are new options for chronic sinusitis that you can discuss with your doctor. This FDA-cleared technology uses a small, flexible, sinus balloon catheter to open up blocked sinus passageways, restoring normal sinus drainage. When the sinus balloon is inflated, it gently restructures and widens the walls of the passageway while maintaining the integrity of the sinus lining.
Sinusitis affects 37 million people each year, 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. Symptoms may significantly affect people physically, functionally, and emotionally.
The Role of the Sinuses
To understand sinusitis, it is important to first learn about your sinuses and their role with your health.
The sinuses are air spaces behind the bones of the upper face, between the eyes and behind the forehead, nose and cheeks. The sinuses are covered with a mucus layer and cells that contain little hairs on their surfaces called cilia. These help trap and push out bacteria and pollutants.
Each sinus has an opening that allows mucous 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 in the sinuses and trigger symptoms that range from minor to severe.
Sinusitis is defined as an inflammation of the sinus lining commonly caused by bacterial, viral and / or microbial infections; as well as, structural issues such as ostial blockage. Symptoms include nasal congestion, facial discomfort, nasal discharge, headache, and fatigue.
Types of Sinusitis
There are two main categories of sinusitis: acute and chronic.
Sinusitis is usually preceded by a cold, allergy attack or irritation from environmental pollutants. Often, the resulting symptoms, such as nasal pressure, nasal congestion, a “runny nose,” and fever, run their course in a few days. However, if symptoms persist, a bacterial infection or acute sinusitis may develop.
Most cases of sinusitis are acute (or sudden onset); however, if the condition occurs frequently or lasts 12 weeks or more, you may have chronic sinusitis.
Facts About Sinusitis
- Sinusitis affects approximately 14% of the adult U.S. population.
- Sinusitis affects 17% of women and 10% of men each year.
- Chronic sinusitis (not including acute sinusitis) results annually in an estimated 18-22 million physician office visits.
- Direct healthcare expenditures due to sinusitis cost are well over $8 billion each year.*
- Sinusitis is also responsible for a significant loss of workplace productivity.
- Total restricted activity days due to sinusitis are well over 73 million per year.
* Inflation Adjusted
Balloon Sinuplasty™ devices are an endoscopic, catheter-based system. To-date this technology has been used in over 80,000 patients and over 200 cases are performed each day. Data published in leading Ear, Nose, and Throat (ENT) medical journals shows that the technology is safe and effective: study participants received significant relief from their symptoms. In addition, patients returned to normal daily activity quickly – often within 24 hours.
Balloon Sinuplasty™ technology is used by qualified ENT physicians and involves the use of tiny balloons to open blocked sinuses similar to how angioplasty uses balloons to open blocked coronary arteries.
The diagram below shows an inflamed left maxillary sinus.
An ENT physician will use Balloon Sinuplasty™ devices to open the blockage that is preventing sinus drainage.
The pictures summarize the steps associated with using the Balloon Sinuplasty™ technology
- Gain Access to the Sinus
To gain initial sinus access, a sinus guide catheter is introduced into the nasal cavity to target the sinus ostia under endoscopic visualization. A sinus guidewire or a sinus illumination system is introduced through the sinus guide catheter and gently advanced into the target sinus.
- Inflate Balloon Across Ostium
The sinus balloon catheter is introduced over the sinus guidewire or sinus illumination system and positioned across the blocked ostium. The position of the sinus balloon catheter is confirmed and the balloon is gradually inflated to open and remodel the narrowed or blocked ostium.
- Remove Balloon and Irrigate Sinus
The sinus balloon catheter is then deflated and removed, leaving the ostium open. The sinus is then irrigated, flushing tenacious sinus contents – like pus and mucus.
- Remove System
The irrigation catheter is removed, leaving the sinus cleared of mucus allowing the return of sinus drainage. There is little to no disruption to mucosal lining.
The benefits of Balloon Sinuplasty™ Technology:
- Safe and Effective
While use of any surgical instrument involves some risk, clinical research has indicated the Balloon Sinuplasty™ System to be safe and effective in improving symptoms of sinusitis.
- Minimally Invasive
The technology uses small, soft, flexible devices that enter entirely through the nostrils. These devices gently open blocked sinus openings, and in many cases, without tissue or bone removal.
- Minimal Bleeding
Because in many instances no tissue or bone is removed when using this technology, there may be little bleeding associated with the procedure.
- Quick Recovery Time
While recovery time varies with each patient, many people can quickly return to normal activities.
- Does Not Limit Treatment Options
This technology is an endoscopic tool and may be used with other medical therapies or sinus surgery techniques. It does not limit future treatment options if you have progressive disease.
Intended for use by or under the direction of a physician. Balloon Sinuplasty™ Technology has associated risks, including tissue and mucosal trauma, infection, or possible optic injury. Consult your physician for a full discussion of risks and benefits to determine whether this procedure is right for you.
Chronic sinusitis symptoms can make you miserable and impact your quality of life. In order to get relief, you need to make the right treatment decision with your doctor.
Over the last 2 years the Balloon Sinuplasty™ technology has emerged as a new complement to existing approaches. The information below summarizes the primary approaches for treating chronic sinusitis.
Sinusitis is typically treated first with medication. Treatment with antibiotics or topical nasal steroid sprays is often successful in reducing mucosal swelling, fighting infection, and relieving obstructions of the sinus opening (ostium). Inhaling steam or use of saline nasal sprays or drops can also help relieve sinus discomfort. However, at least 20% of patients do not respond adequately to medications.1,2,3,4
Endoscopic Sinus Surgery (ESS)
The goals of sinus surgery are to clear blocked sinuses restoring normal sinus drainage and to preserve normal anatomy and mucosal tissue. Specialized instruments are placed into the nose along with a small endoscope to help the surgeon see inside the nose and nasal cavities.
Sinus surgery with traditional instrumentation removes bone and tissue to enlarge the sinus opening. The removal of bone and tissue may lead to post-operative pain, scarring, and bleeding. Uncomfortable nasal packing may be required to control the bleeding.
The Balloon Sinuplasty™ Technology: Novel, Endoscopic, Catheter-Based Devices
Sinus surgery with Balloon Sinuplasty™ technology utilizes a small, flexible, sinus balloon catheter that is placed into the nose to reach the sinuses. The sinus balloon catheter is gradually inflated to gently restructure the previously blocked nasal passage, maintaining the integrity of the sinus lining and restoring normal sinus drainage and function. There is minimal bleeding, and many patients have been able to return to normal activities within 24 hours. Clinical research has indicated that the Balloon Sinuplasty™ system is a safe and effective tool in dilating blocked sinuses.5
Visit BalloonSinuplasty.com to learn more about Balloon Sinuplasty™ technology.
1. Hamilos, D., J Allergy Clin Immunol 2000; 106: 213-227.
2. Stankiewicz, J., et al, Am J Rhinol 2003; 17(3): 139-142.
3. Subramanian, H., et al, Am J Rhinol 2002; 16(6): 303-312.
4. Hessler, J., et al, Am J Rhinol 2007; 21(1): 10-18.
5. Weiss, R., et al, Otolaryngol Head Neck Surg 2008; 139: S38-S46.
What is the Balloon Sinuplasty™ system?
Does surgery with the Balloon Sinuplasty™ technology work?
How long does symptom relief last after surgery with Balloon Sinuplasty™ technology?
How do sinus openings stay open after surgery with Balloon Sinuplasty™ technology?
Are the Balloon Sinuplasty™ devices safe?
What are the risks of surgery with Balloon Sinuplasty™ technology?
How long does surgery with Balloon Sinuplasty™ technology take?
Will I require general anesthesia for surgery with Balloon Sinuplasty™ technology?
How long does it take to recover from a typical surgery using the Balloon Sinuplasty™ system?
Does surgery with Balloon Sinuplasty™ devices limit my treatment options?
Are Balloon Sinuplasty™ devices right for me?
Who uses Balloon Sinuplasty™ devices?
Are Balloon Sinuplasty™ devices covered by Medicare?
Are Balloon Sinuplasty™ devices covered by other insurance carriers?
- What is the Balloon Sinuplasty™ system?
The Balloon Sinuplasty™ system is the name used for a group of medical devices that are used to create openings in your sinuses. The devices use a small, flexible balloon that is placed into the nose to reach the sinuses. The balloon is gradually inflated to gently restructure the previously blocked nasal passage, restoring normal sinus drainage.
- Does surgery with the Balloon Sinuplasty™ technology work?
Clinical research has indicated that using Balloon Sinuplasty™ technology is safe and effective in dilating sinus openings.
- How long does symptom relief last after surgery with Balloon Sinuplasty™ technology?
Results vary by individual. Published clinical data has shown the following regarding patients who have had sinus surgery with Balloon Sinuplasty™ technology:
A study of 1,036 patients at multiple institutions reported that sinus symptoms improved in 96% of patients at an average follow-up period of 10 months.
Another study followed 61 patients at multiple institutions and reported average improvement in symptoms to be clinically and statistically significant out to two years.
- How do sinus openings stay open after surgery with Balloon Sinuplasty™ technology?
Balloon Sinuplasty™ technology dilates sinus openings, or ostia by pushing aside bones which comprise the sinus ostia. Moving bone remodels the sinus ostia, creating wider openings.
- Are the Balloon Sinuplasty™ devices safe?
The Balloon Sinuplasty™ technology is minimally invasive and has been clinically demonstrated to be safe by leading Ear, Nose and Throat doctors. more than 5,300 surgeons have been trained on Balloon Sinuplasty™ and over 84,000 patients and 252,000 sinuses have been treated with Balloon Sinuplasty™. Each day approximately 200 sinus surgeries are being performed with Balloon Sinuplasty™ technology. Finally, unlike other surgical methods used to clear blocked sinus openings, Balloon Sinuplasty™ technology does not remove any bone or tissue and some patients return to normal activities quicker – within 24 hours without other co-morbid conditions.
- What are the risks of surgery with Balloon Sinuplasty™ technology?
Your healthcare provider can best explain the potential risks of surgery with Balloon Sinuplasty™ technology.
- How long does surgery with Balloon Sinuplasty™ technology take?
The duration of the procedure varies by individual situations. Ask your healthcare provider for the most accurate answer.
In a study of 1,036 patients who underwent sinus surgery with Balloon Sinuplasty™ technology at multiple institutions, an average procedure time was 3 hours, including the surgery and post-anesthesia recovery time. None of the patients required an overnight stay at the hospital.
- Will I require general anesthesia for surgery with Balloon Sinuplasty™ technology?
Most patients undergo general anesthesia for sinus surgery with Balloon Sinuplasty™ technology, but some patients have had the procedure under local anesthesia. Your healthcare provider can best advise you on your anesthesia options.
- How long does it take to recover from a typical surgery using the Balloon Sinuplasty™ system?
Because the system is minimally invasive it is typically used in an outpatient setting. While recovery time will vary from patient to patient, many people can return to normal activities within 24 hours after surgery.
- Does surgery with Balloon Sinuplasty™ devices limit my treatment options?
No. Balloon Sinuplasty™ devices are endoscopic tools used within conventional sinus surgery and may be used with other medical therapies. They do not limit future treatment options for patients.
- Are Balloon Sinuplasty™ devices right for me?
If you suffer from sinusitis, and medication alone has not been effective in relieving your symptoms, you may be a candidate for surgery using the Balloon Sinuplasty™ devices. To find out if you are a candidate for the Balloon Sinuplasty™ devices, please visit the “Is Balloon Sinuplasty Right for You” page listed in the side navigation. We also encourage you to talk to your doctor about whether use of these FDA-cleared, endoscopic, catheter-based tools is right for you.
- Who uses Balloon Sinuplasty™ devices?
Ear, Nose, and Throat physicians who have been trained on the Relieva Balloon Sinuplasty™ devices.
- Are Balloon Sinuplasty™ devices covered by Medicare?
Yes. Medicare covers endoscopic sinus surgery when any combination of tools, including a balloon catheter, is used to perform the procedure.
- Are Balloon Sinuplasty™ devices covered by other insurance carriers?
Most insurance companies cover sinus surgery with Balloon Sinuplasty™ devices. To be certain of your coverage, contact your insurance provider to find out your specific coverage policy.
With tens of thousands of patients worldwide who have had surgery with Balloon Sinuplasty™ technology, and hundreds more experiencing it each day, there are many success stories. These former chronic sinusitis sufferers have experienced immediate and long-term relief, better quality of life, and a more active lifestyle following the procedure.
Below are just a few of the success stories shared by patients who have benefited from Balloon Sinuplasty™ technology.
“After my NFL football career, when I wasn’t working out every day of my life, my sinus problems started to magnify. When I was at work broadcasting, I started having severe post nasal drip and started taking allergy medicine and using nasal pumps.”
– Marshall Faulk, NFL MVP, Superbowl Champion, Broadcaster
“Before surgery with Balloon Sinuplasty™ technology, a typical day would start with a headache, sinus congestion, and ear fullness. Sometimes my sinuses were so swollen that I’d go out in the cold air to have them shrink, or place ice packs on my head. Since surgery with Balloon Sinuplasty™ technology, my life has improved 100%. Now, I wake up in the morning and do normal things like everyone else does. I make my morning coffee, and eat and drink whatever I want to. I don’t have to worry about anything, and I feel like a regular person!”
– Carrie M., Courtroom Clerk
“I had sinus surgery using Balloon Sinuplasty™ technology ten months ago. The results have been truly awesome, and recovery after the surgery was fast and painless. Besides getting over the effects of general anesthesia, I did not experience any post-operative discomfort. I was totally amazed. Immediately following the procedure, I noticed how well I was able to breathe. My sinuses felt like a wind tunnel! Ten months later, my sinuses are still properly draining and I’ve stopped taking nasal sprays. I haven’t stopped bragging about the results!”
– Evelyn H., Operating Room Nurse Manager
“I had five previous sinus surgeries before surgery with Balloon Sinuplasty™ technology. After these prior surgeries, my face was bruised, I had a lot of bleeding, and I was in a lot of pain. In contrast, right after surgery with Balloon Sinuplasty™ technology, I woke up and felt great. When I walked out of the building an hour or two after my surgery to go home, I could smell that there was a fire close by! I was amazed at how quickly after the surgery I was able to breathe. It’s been a year and a half since the surgery, and I have felt awesome!”
– Sally M., 5th Grade Teacher/Caregiver to young son
“When I was having problems with sinusitis, I would feel embarrassed, because my patients were seeing me to get better, not to get sick. I didn’t feel like going out at night, and didn’t always have energy for my five young grandsons. Since the surgery with Balloon Sinuplasty™ technology, I have energy to work a full day and go out at night. It’s made a tremendous difference in how I approach my life. As for my patients who are suffering from chronic sinusitis, aren’t responding to medical therapy, and have the blockage like I had – I don’t hesitate to recommend surgery with Balloon Sinuplasty™ technology.”
– Sherwin G., Allergist
“Before I had surgery with Balloon Sinuplasty™ technology, people would say to me, “You always have a cold,” because I was always congested. I had difficulty breathing, sometimes couldn’t talk on the phone at work, and had complete loss of taste and smell. Since surgery with Balloon Sinuplasty™ technology, my breathing has been 100% better. I can actually close my mouth and breathe at the same time, and I speak on the phone with much more clarity. It’s also nice to sit down to a meal and enjoy the smell and taste of my food.”
– Susan C., Realtor/Salesperson