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.
Clinical research has indicated that using Balloon Sinuplasty Technology is safe and effective in dilating sinus openings.
Results vary by individual. Published clinical data has shown the following regarding patients who have had sinus 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.
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.
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.
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.
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.
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.
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.
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.
Ear, Nose, and Throat physicians who have been trained on the Relieva Balloon Sinuplasty devices.
Yes. Medicare covers endoscopic sinus surgery when any combination of tools, including a balloon catheter, is used to perform the procedure.
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.
Balloon Sinuplasty Technology is 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.
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