Balloon Sinuplasty™ technology is a FDA-cleared, endoscopic, catheter-based system for patients suffering from sinusitis. The technology uses a small, flexible, Sinus Balloon Catheter to open up blocked sinus passageways, restoring normal sinus drainage and function. When the sinus balloon is inflated, it gently restructures and widens the walls of the passageway while maintaining the integrity of the sinus lining.
Step 1. A balloon catheter is inserted into the inflamed sinus.
Step 2. The balloon is inflated to expand the sinus opening.
Step 3. Saline is sprayed into the inflamed sinus to flush out the pus and mucus.
Step 4. The system is removed, leaving the sinuses open.
Safe and Effective
While use of any surgical instrument involves some risk, clinical studies have indicated the Balloon SinuplastyTM system to be safe and effective in relieving symptoms of sinusitis.
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.
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.
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.
Common symptoms include:
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.
Two approaches have emerged for treating sinusitis patients:
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.
"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.
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.
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.
Clinical studies have indicated that using Balloon Sinuplasty™ technology is safe and effective in dilating sinus openings.
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.
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.
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.
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.