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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.

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.

For how long does Balloon Sinuplasty™ technology relieve symptoms?

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 Balloon Sinuplasty™ surgery?

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 Balloon Sinuplasty™ surgery?

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 Balloon Sinuplasty™ surgery?

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 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. 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.

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1-888-243-3627

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