Balloon Sinuplasty

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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.

Steps in using the Balloon Sinuplasty™ technology
The technology is used by qualified Ear, Nose, and Throat physicians. The following pictures summarize the steps associated with using the Balloon Sinuplasty™ Technology.

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Gain Access to the Sinus.

To gain initial sinus access, a sinus guide catheter is introduced into the nasal cavity to target the sinus ostia under endoscopic visualization. A sinus guidewire or a sinus illumination system is introduced through the sinus guide catheter and gently advanced into the target sinus.

Inflate Balloon Across Ostium.
The sinus balloon catheter is introduced over the sinus guidewire or sinus illumination system and positioned across the blocked ostium. The position of the sinus balloon catheter is confirmed and the balloon is gradually inflated to open and remodel the narrowed or blocked ostium.
Deflate and Remove Balloon.
The sinus balloon catheter is then deflated and removed, leaving the ostium open allowing the return of normal sinus drainage and function. There is little to no disruption to mucosal lining.


Benefits in Using the Balloon Sinuplasty™

  • Safe and Effective
    While use of any surgical instrument involves some risk, clinical studies have 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. As a result, the need for uncomfortable nasal packing may also be eliminated.
  • 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.

Video provided by Acclarent, Inc. – Click to play.

 
Sinusitis Frequently Asked Questions

(Please also review the in-depth Health Info article – Sinusitis)

What is sinusitis?
Sinusitis is an inflammation of the sinus lining commonly caused by bacterial, viral, and / or microbial infections; as well as, structural issues such as blockage of the sinus opening (ostium). If the ostium becomes swollen shut, normal mucus drainage may not occur. This condition 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
  • Nasal obstruction or blockage
  • Discharge of discolored mucus from the nose
  • Discolored post-nasal drainage
  • Loss of smell
  • Headache
  • Fatigue

What types of doctors treat sinusitis?
Many types of doctors treat sinusitis, including general and family practice physicians, pediatricians, and allergists. However, if a patient has chronic sinusitis or does not respond to medical treatment, he or she may be referred to a specialist – an Ear, Nose, and Throat (ENT) physician, or otolaryngologist.

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

  • Medical therapies
  • Endoscopic surgical interventions

Sinusitis is treated initially with medical therapies. Usually antibiotics or topical nasal steroid sprays are given to reduce mucosal swelling, fight infection, and relieve obstruction at the sinus opening (ostium). These therapies are often effective in reducing sinusitis symptoms. However, for many other patients, these medications are inadequate and sinus surgery may be the next step in finding relief.

Surgery may be indicated for those patients whose symptoms and ostial obstruction persist despite medical therapy. With the advent of FESS (Functional Endoscopic Sinus Surgery), sinus surgery has evolved from open and invasive procedures to less invasive surgical techniques. Along with this evolution, many endoscopic tools have been developed to further assist and help improve FESS techniques. These tools include an array of devices such as the microdebrider and the sinus balloon catheter.

What is “sinuplasty”?
“Sinuplasty” is the term that is sometimes used to refer to the Relieva Balloon Sinuplasty™ devices that your surgeon may choose to use during your FESS procedure.

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. Using the endoscope and a combination of surgical tools, e.g., curettes, forceps, powered micro-debriders, powered shavers, and / or sinus balloon catheters, surgeons enlarge the patient’s sinus openings to clear passageways in order to restore normal sinus ventilation and drainage.

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?
While use of any surgical instrument involves some risk, clinical research has indicated the Balloon Sinuplasty™ System to be safe and effective in improving symptoms of sinusitis.

Are the Balloon Sinuplasty™ devices safe?
Balloon catheter technology has been used successfully in other medical procedures such as balloon angioplasty for the heart. A Balloon Sinuplasty™ procedure is intended only for use by a certified physician. Balloon Sinuplasty™ Technology has associated risks, including tissue and mucosal trauma, infection, or possible optic injury.

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 the 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 Acclarent Relieva Balloon Sinuplasty™ system.

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