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Balloon Sinuplasty: Frequently Asked Questions

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.
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.

What is "Balloon Sinuplasty™"?

The words, “Balloon Sinuplasty™,” when used together, describe the use of a sinus balloon catheter to surgically repair the sinus ostia during a FESS procedure. FESS is a minimally invasive surgical procedure to open up air cells and sinus ostia (openings) in patients suffering from chronic sinusitis. FESS involves the insertion of an endoscope into the nose for a direct visual examination of the openings into the sinuses. ...
The words, “ Balloon Sinuplasty ™ ,” when used together, describe the use of a sinus balloon catheter to surgically repair the sinus ostia during a FESS procedure. FESS is a minimally invasive surgical procedure to open up air cells and sinus ostia (openings) in patients suffering from chronic sinusitis. FESS involves the insertion of an endoscope into the nose for a direct visual examination of the openings into the sinuses. ...

What is "Balloon Sinuplasty TM "?

The words, “ Balloon Sinuplasty TM ,” when used together, describe the use of a sinus balloon catheter to surgically repair the sinus ostia during a FESS procedure. FESS is a minimally invasive surgical procedure to open up air cells and sinus ostia (openings) in patients suffering from chronic sinusitis. FESS involves the insertion of an endoscope into the nose for a direct visual examination of the openings into the sinuses. ...

Who uses Balloon Sinuplasty™ devices?

Ear, Nose, and Throat physicians who have been qualified on the Balloon Sinuplasty™ technology by Acclarent. back to top Sinusitis FAQs
Ear, Nose, and Throat physicians who have been qualified on the Relieva Balloon Sinuplasty™ system. 1. Data on file at Acclarent, Inc.
Ear, Nose, and Throat physicians who have been trained on the Relieva Balloon Sinuplasty ™ devices.

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.
Clinical research has indicated that using Balloon Sinuplasty ™ technology is safe and effective in dilating sinus openings.
Clinical studies have indicated that using Balloon Sinuplasty ™ technology is safe and effective in dilating sinus openings.1

Are the Balloon Sinuplasty™ devices safe?

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

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 TM devices?

The Balloon Sinuplasty TM 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.

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.

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.
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.

Are Balloon Sinuplasty ™ devices covered by Medicare?

Yes. Medicare covers Balloon Sinuplasty ™ devices.

Are the Balloon Sinuplasty TM devices safe?

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

Are Balloon Sinuplasty TM 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 TM devices. Talk to your doctor about whether use of these FDA-cleared, endoscopic, catheter-based tools are right for you.

Does surgery with the Balloon Sinuplasty TM technology work?

Clinical studies have indicated that using Balloon Sinuplasty TM technology is safe and effective in dilating sinus openings. 1

Who uses Balloon Sinuplasty TM devices?

Ear, Nose, and Throat physicians who have been qualified on the Relieva Balloon Sinuplasty TM system. To find a doctor in your area that is qualified on the Balloon Sinuplasty TM system, click here . 1. Weiss, R., et al, Otolaryngol Head Neck Surg 2008; 139: S38-S46.

Does surgery with Balloon Sinuplasty ™ devices limit my treatment options?

B alloon 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.
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.

How long does surgery with Balloon Sinuplasty ™ technology take?

The duration of the procedure varies by indvidual 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-anexthesia recovery time. None of the patient required an overnight stay at the hospital.

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.

Does surgery with Balloon Sinuplasty TM devices limit my treatment options?

Balloon Sinuplasty TM 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.

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.
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