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Balloon Sinuplasty

Balloon sinuplasty is an endoscopic surgical procedure for the treatment of blocked nasal sinuses. Patients diagnosed with chronic sinusitis but not responding well to medications may be candidates for some type of sinus surgery. Two options are balloon sinuplasty and functional endoscopic sinus surgery (FESS).

Balloon sinuplasty is an endoscopic, catheter-based system for patients suffering from sinusitis. The procedure has been cleared by the U.S. Food and Drug Administration. It uses a small, flexible balloon catheter to enlarge sinus passageways. When the balloon is inflated, it restructures and widens the walls of the sinus passageway, with the goal of restoring normal sinus drainage without damaging the sinus lining.

Balloon Sinuplasty™ Technology provides surgeons with an endoscopic, catheter-based system to open blocked sinuses 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 statistically and clinically significant improvement in 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.

During sinus surgery, 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:

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 tools used to clear blocked sinus openings,Balloon Sinuplasty™ Technology does not remove any bone or tissue and many patients can quickly return to normal activities.

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. 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.

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 quickly return to normal activities.

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 theBalloon 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.