Sinusitis Overview

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.

Click on each link to learn more about the issues surrounding Sinusitis.

Role of the Sinuses | Symptoms of Chronic Sinusitis | Treatment Options |
Watch Our Sinuplasty Video | What is Balloon Sinuplasty™ | Balloon Sinuplasty™ Benefits |
FAQs | Is Balloon Sinuplasty™ Right for You?


The Role of the Sinuses

To understand sinusitis, it is important to first learn about your sinuses and their role with your health.

Sinus Diagram

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.

Experts agree that healthy sinuses are a key to a good quality of life and that unhealthy sinuses may cause some unwanted complications.


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.
  • Total restricted activity days due to sinusitis are well over 73 million per year.

What are the Symptoms of Chronic Sinusitis

Sinusitis (also called rhinosinusitis) is the name of the condition in which the lining of your sinuses becomes inflamed. The sinuses are air spaces behind the bones of the upper face, between the eyes and behind the forehead, nose and cheeks.

Sinus Opening

Normally, the sinuses drain through small openings into the inside of the nose. Anything that blocks the flow may cause a buildup of mucus in the sinuses. The blockage and inflammation of the sinus membranes can be infectious or non-infectious.

The symptoms caused by sinusitis may be quite uncomfortable. The signs and symptoms may include:

  • Facial pain, pressure, congestion or fullness
  • Difficulty breathing through the nose
  • Discharge of yellow or green mucus from the nose
  • Teeth pain
  • Loss of the sense of smell or taste
  • Headache
  • Fatigue
  • Sore throat
  • Bad breath

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 three months or more, you may have chronic sinusitis.

Find out how you might relieve the symptoms associated with chronic sinusitis.


What are my treatment options?

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 three primary approaches to treating chronic sinusitis.

Medical Therapy
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.

Conventional Sinus Surgery
The goals of sinus surgery are to clear blocked sinuses restoring normal sinus drainage and to preserve normal anatomy and mucosal tissue. Conventional sinus surgery is called Endoscopic Sinus Surgery (ESS). With ESS, specialized instruments are placed into the nose along with a small endoscope to help the surgeon see inside the nose and nasal cavities. The procedure works by removing 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
This 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.

Read more about Balloon Sinuplasty™ technology.




What is Balloon Sinuplasty™?

The painful symptoms associated with chronic sinusitis can be overwhelming. If symptoms are difficult to control with medications alone, your primary doctor may refer you to an Ear, Nose and Throat (ENT) specialist, who can determine the best course of treatment, including further medication therapy or surgery to open the sinus passage ways.

Now, there is an additional surgical option for treatment of blocked sinuses called Balloon Sinuplasty™ technology. If you have been diagnosed with chronic sinusitis and are not responding well to antibiotics you may be a candidate for surgery, you now have a less invasive option that is clinically proven to be safe, effective and improve the quality of your life.

Balloon Sinuplasty™ technology is an endoscopic, catheter-based system for patients suffering from sinusitis. The 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.

Technology Overview
Balloon Sinuplasty™ devices provide an endoscopic, catheter-based system for patients suffering from sinusitis. Recently published data in the leading ENT journal shows that the technology is safe and effective: study participants experienced no adverse events and received significant relief from their symptoms.

Balloon Sinuplasty™ technology is used by qualified Ear, Nose, and Throat (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 frontal sinus.

Sinus Diagram 2

In order to improve symptoms of chronic sinusitis, an ENT physician will use Balloon Sinuplasty™ devices to open the blockage that is preventing sinus drainage.

The following picture summarizes the steps associated with using the Balloon Sinuplasty™ technology:

Sinuplasty Steps

Learn more about the benefits of using Balloon Sinuplasty™ technology to treat chronic sinusitis.


Balloon Sinuplasty™ Benefits


The benefits of Balloon Sinuplasty™ technology for treating chronic sinusitis symptoms include:

  • 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 relieving 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.
  • Reduced Bleeding
    Because in many instances no tissue or bone is removed when using this technology, there may be reduced bleeding associated with the procedure.
  • Improved Recovery Time
    While recovery time varies with each patient, many people can return to normal activities within 24 hours.
  • 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.


As with use of any surgical instrument, there are risks, and results may vary from patient to patient. Talk with your doctor about your specific condition to find out if the Balloon Sinuplasty™ system is right for you.


FAQs

What is sinusitis?
Sinusitis is an inflammation of the sinus lining. If the sinus opening becomes swollen shut, normal mucus drainage may not occur, and this may lead to infection and inflammation of the sinuses.

What are the common symptoms of sinusitis?
Common symptoms include:

  • Facial pain, pressure, congestion or fullness
  • Difficulty breathing through the nose
  • Discharge of yellow or green mucus from the nose
  • Teeth pain
  • Loss of the sense of smell or taste
  • Headache
  • Fatigue
  • Sore throat
  • Bad breath

What types of doctors treat sinusitis?
Many types of doctors treat sinusitis, including general and family practice physicians, pediatricians, and allergists. However, if you have chronic sinusitis or do not respond to medical treatment, you may be referred to a specialist - an Ear, Nose, and Throat (ENT) physician, or Otolaryngologist.

How is sinusitis treated?
Three approaches have emerged for treating sinusitis patients:

  • Medical therapy
  • Endoscopic sinus surgery with cutting instruments
  • Endoscopic sinus surgery with balloon catheters

Medical Therapy
Sinusitis is typically treated first with medication. Treatment with antibiotics or topical nasal steroid sprays is successful for many sinusitis sufferers. Inhaling steam or use of saline nasal sprays or drops can also help. However, at least 20% of patients do not respond adequately to medications.

Endoscopic Sinus Surgery (with cutting instruments)
Sinus surgery aims to clear blocked sinuses and restore normal sinus drainage. The procedure removes bone and tissue to enlarge the sinus opening. The removal of bone and tissue may lead to pain, scarring, and bleeding.

Endoscopic Sinus Surgery (with Balloon Sinuplasty™ technology)
The technology utilizes a small, flexible, Sinus Balloon that is placed into the nose to reach the sinuses. The Sinus Balloon is gradually inflated to gently restructure the previously blocked sinus opening which helps to restore 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 instrument in dilating blocked sinuses.

Read more about Balloon Sinuplasty™ technology.

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.

What are the Balloon Sinuplasty™ devices?
The Balloon Sinuplasty™ devices are FDA-cleared, endoscopic, catheter-based instruments specifically designed to be used in sinus surgery. The Sinus Balloon Catheter is gradually inflated to gently restructure the previously blocked sinus opening, which restores normal sinus drainage, without damaging the sinus.

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 65 patients at multiple institutions and reported clinically and statistically significant improvement in patient symptoms out to 2 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. 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. In all published clinical data, no serious adverse events attributable to the Balloon Sinuplasty™ system have been reported.

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 patient 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 patient 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, click here. 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.

What are patients saying about sinus surgery with Balloon Sinuplasty™ technology?
Click here to see what other patients are saying about their experiences with the Balloon Sinuplasty™ technology.

What are physicians saying about sinus surgery with Balloon Sinuplasty™ technology?
Click here to see what doctors are saying about their experiences with the Balloon Sinuplasty™ technology.

How do I find an ENT physician in my area that is trained to use Balloon Sinuplasty™ devices?
Click here to get a list of doctors in your area trained on the use of the technology.



Is Balloon Sinuplasty™ right for you?

Balloon Sinuplasty™ technology allows for a minimally invasive approach to treating chronic sinusitis symptoms that is clinically proven to be safe and effective.
Please answer a few questions below to see if this technology may be the right choice for you. If you appear to be a candidate, we will contact you for an appointment through email or a contact number.

Name

Email

Phone Number


Do you experience any of the following symptoms?


Has a doctor prescribed medication for you to address your sinus condition(s)?
Yes No

In the past year, how many weeks have you taken medication for your sinus condition?
Does Not Apply    Less Than 4 Weeks
4—5 Weeks            6—8 Weeks
9 —12 Weeks        More Than 12 Weeks

Has your doctor referred you to an Ear, Nose & Throat Specialist?
Yes No