Is Balloon Sinuplasty cleared for use by the FDA?
Balloon Sinuplasty received FDA clearance in 2005. Over 375,000 patients have been treated by ENT surgeons using this technology.
Does Balloon Sinuplasty Work?
Clinical research confirms that Balloon Sinuplasty provides long-term relief from sinus symptoms by effectively opening blocked sinus passageways. 3
Is the Effect of This Procedure Permanent or Might I Have to Undergo Repeated Procedures?
How long your sinuses stay open depends on the extent of your sinus disease or other factors. Balloon Sinuplasty restructures the sinus opening, restoring normal sinus drainage. It is unlikely that you would require repeat procedures, but the procedure may be repeated if your ENT deems it necessary.
How Many People Have had the Balloon Sinuplasty Procedure?
More than 375,000 people around the world have experienced Balloon Sinuplasty, including over 35,000 people in the office setting.
What are the Advantages of the Balloon Sinuplasty Over Traditional Sinus Surgery?
Balloon Sinuplasty is less invasive than traditional sinus surgery with minimal bleeding. 4 While recovery time varies with each patient, recovery is typically fast. In a study of in-office balloon dilation, most patients returned to work and normal activity within 2 days. 5
Is Balloon Sinuplasty Safe?
Yes. Clinical studies have shown that Balloon Sinuplasty is safe, minimally invasive, and significantly improves quality of life. 3
What Material is the Balloon Made From?
The balloon is made from a high strength plastic that does not contain latex.
What are the Risks Associated with Balloon Sinuplasty?
Because Balloon Sinuplasty is minimally invasive, there is a very low complication rate. But there are some associated risks, including tissue and mucosal trauma, infection, or possible optic injury. Talk with your doctor about the risks and benefits and to determine whether Balloon Sinuplasty is right for you.
How Long Does the Balloon Sinuplasty Procedure Take?
Since the duration of the procedure varies, ask your healthcare provider for the most accurate answer. However, in a study of more than 1,000 patients, the average procedure time in the operating room was 73 minutes. 4 None of the patients required an overnight stay at the hospital.
Will I Require General Anesthesia During Balloon Sinuplasty?
An increasing number of ENT doctors perform the procedure in the office, under local anesthesia. Your healthcare provider can best advise you on your anesthesia options.
How Long Does It Take to Recover After Balloon Sinuplasty?
Patients go home the same day that they have the procedure. While recovery time will vary from patient to patient, many people can quickly return to normal activities. 5
Does Balloon Sinuplasty Limit my Future Sinusitis Treatment Options?
No. Surgeons may use Balloon Sinuplasty with other medical therapies, and it does not limit future treatment options for patients.
Is Balloon Sinuplasty Right for Me?
No. ENT doctors may use Balloon Sinuplasty with other medical therapies, and it does not limit future treatment options for patients.
Can Balloon Sinuplasty Be Used in Children?
Yes, Balloon Sinuplasty is a safe and effective option to relieve chronic sinusitis symptoms in children’s maxillary sinuses.
How Much Does Balloon Sinuplasty Cost?
Your cost will vary depending on your insurance coverage and if you have the procedure performed in the office or hospital. Speak with your insurance company about the cost.
Is Balloon Sinuplasty Covered by Medicare?
Yes. Medicare covers Balloon Sinuplasty both in the office and hospital settings.
Is Balloon Sinuplasty Covered by My Insurance Carrier?
Although the majority of insurance carriers cover Balloon Sinuplasty, contact your insurance provider to determine your specific policy.
Sources:
- Weiss, et al. “Long-term outcome analysis of balloon catheter sinusotomy: Two-year follow-up.” Otolaryngology-Head and Neck Surgery, 2008, Vol. 139, pp. S38-S46.
- Levine et al. Multicenter Registry of Balloon Catheter Sinusotomy Outcomes for 1,036 Patients, Annals of Otology, Rhinology, and Laryngology, 2008, Vol. 117, pp. 263-270.
- Karanfilov B, Silvers S, Pasha R, Sikand A, Shikani A, Sillers M; for the ORIOS2 study investigators. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol. 2013;3(5):404-411.
