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 reac the lungs.

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. The impact of chronic sinusitis on a person's quality of life could include: throbbing facial pain or headaches, congestion, bad breath, irritability, fatigue or nausea.

Healthcare professionals often find it difficult to treat the majority of chronic sinusitis sufferers with medication. In fact, it is estimated that up to 60 percent of chronic sinusitis sufferers are not successfully treated with medication.6 Patients who do not respond well to medications become candidates for conventional sinus surgery, which is known as functional endoscopic sinus surgery (FESS).

Since the 1980s, FESS has been the standard of care for sinus surgery. FESS aims to clear blocked sinuses and restore normal sinus drainage by removing bone and tissue to enlarge the sinus opening, which may lead to pain, scarring and bleeding.

However, conventional sinus surgery no longer has to be the only option for chronic sinusitis patients who are not responding well to medications. Balloon Sinuplasty™ is a breakthrough procedure that relieves the pain and pressure associated with chronic sinusitis. To learn more about chronic sinusitis, visit the American Academy of Otolaryngology‐Head and Neck Surgery (www.entnet.org). For more information about Balloon Sinuplasty™, visit www.balloonsinuplasty.com.

Balloon Sinuplasty™ for Chronic Sinusitis Relief

Balloon Sinuplasty™ is a breakthrough procedure that relieves the pain and pressure associated with chronic sinusitis. It is used by surgeons to safely and effectively treat chronic sinusitis patients who are not responding well to medications such as antibiotics, nasal steroids, or over‐the‐counter (OTC) drugs, and are seeking relief from uncomfortable and painful sinusitis symptoms.

Similar to how angioplasty uses balloons to open blocked arteries, Balloon Sinuplasty™, a system of FDA‐cleared, catheter‐based instruments, opens blocked sinuses.

The procedure is less invasive than traditional sinus surgery. It allows most patients to return to normal activities quickly.

With Balloon Sinuplasty™, a specially‐designed catheter is inserted into the nose to reach the inflamed sinus cavity. A small balloon is slowly inflated, which widens and restructures the walls of the sinus passage, helping to drain mucus from the blocked sinus and restore normal sinus drainage without cutting and with minimal bleeding. This approach also preserves the natural structure of the sinuses.

Published clinical data shows that Balloon Sinuplasty™ provides symptom relief for the majority of patients:

In the operating room:

  • A multi‐center study of 1,036 patients who had Balloon Sinuplasty™ reported that sinus symptoms improved in 95 percent of patients at anaverage follow‐up period of 9 months.
  • Another multi‐center study followed 65 patients who had Balloon Sinuplasty™ and reported clinically and statistically significant improvement in patient symptoms out to two years.

 

In the office:

  • Ninety‐five percent of patients who have had Balloon Sinuplasty™ say they would have it again.

 

Balloon Sinuplasty™ is performed under general anesthesia in an outpatient setting; however, some surgeons are choosing to treat certain patients in their office under local anesthesia. The reported complication rate for Balloon Sinuplasty™ is low.

Patients who suffer from chronic sinusitis and are not responding well to medications may benefit from seeing an Ear, Nose, and Throat (ENT) physician who performs Balloon Sinuplasty™ to determine if the procedure is right for them. Most insurance companies and Medicare provide coverage for Balloon Sinuplasty™.

Balloon Sinuplasty™ has been used to treat more than 160,000 patients since receiving FDA clearance.

Steps Associated with Balloon Sinuplasty™

Balloon Sinuplasty™ opens blocked sinus cavities in four easy steps: 1) a guide wire and balloon catheter are inserted into the inflamed sinus, 2) the balloon is inflated to expand the sinus opening, 3) Saline is sprayed into the infected sinus cavity to flush out pus and mucus, and 4) the system is removed, leaving the sinuses open.

What are the Balloon Sinuplasty™ devices?

The Balloon Sinuplasty™ devices are FDA-cleared, endoscopic, catheter-based tools specifically designed to be used in sinus surgery. 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.

Does surgery with the Balloon Sinuplasty™ technology work?

Clinical studies have indicated that using Balloon Sinuplasty™ technology is safe and effective in dilating sinus openings.

Are the Balloon Sinuplasty™ devices safe?

While use of any surgical instrument involves some risk, clinical research has indicated the Balloon Sinuplasty™ technology to be safe.1 Furthermore, balloon catheter technology has been used successfully in other medical procedures such as balloon angioplasty for the heart.

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 FESS and may be used with other medical therapies. They do not limit future treatment options for patients with progressive disease.

Are Balloon Sinuplasty™ devices right for me?

If you suffer from sinusitis, and medical therapy has not been effective in relieving your symptoms, you may be a candidate for surgery using the Balloon Sinuplasty™ devices. Talk to your doctor about whether use of these FDA-cleared, endoscopic, catheter-based tools are right for you.

Who uses Balloon Sinuplasty™ devices?

Ear, Nose, and Throat physicians who have been qualified on the Relieva Balloon.

Should you need any of these diagnostic tests, the physicians and/or audiologists can explain the procedure to you in detail.