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 chose 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?
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.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.1
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 Sinuplasty™ system.
1. Data on file at Acclarent, Inc.
