What are Balloon Sinuplasty™ devices?
Balloon Sinuplasty™ devices are an FDA-cleared and Health Canada approved, catheter-based technologies specifically designed to navigate the tortuous sinus anatomy. The Relieva Sinus Balloon system is used to open the blocked sinus ostium, and in many cases, without tissue or bone removal. Using the Relieva Sinus Balloon system, the blocked sinus ostium is gently dilated restoring normal sinus drainage and function.
What types of doctors use Balloon Sinuplasty™ devices?
Otolaryngologist qualified on the Relieva Balloon Sinuplasty™ system of products. To locate a doctor qualified on the the Balloon Sinuplasty™ devices, visit www.acclarent.com.
Are the products currently available?
All products (Relieva Sinus Access and Sinus Balloon products) are cleared by the FDA and available for human use.
What are the benefits of using Balloon Sinuplasty™ devices’?
- Safe and effective – While use of any surgical instrument involves some risk, studies demonstrate that the Balloon Sinuplasty™ system may be safe and effective in relieving symptoms of sinusitis.
- Minimally invasive – The technology uses small, soft, flexible devices introduced entirely through the nostrils. These devices gently open blocked sinuses.
- Reduced bleeding – In many cases, no tissue or bone is removed during surgery using this technology, because of this there may be reduced bleeding. As a result, the need for uncomfortable nasal packing may also be eliminated.
- Fast recovery time – While recovery time varies with each patient, some patients have been known to return to normal activities within 24 hours.
- Does not limit treatment options – The Balloon Sinuplasty™ technology is an endoscopic tool and may be used with other medical therapies and/or surgical techniques. It does not limit future treatment options if a patient has progressive disease.
Balloon sinuplasty was first introduced in North America in 2005. It is based on minimal invasive surgery to open the sinus drainage pathways without removal of any obstructive shelves or inflammation. The principle is that if the bony shelves and diseased tissue obstructing the drainage pathways can be ‘pushed’ out of the way, the sinuses will start draining and recover their original non-diseased function. Currently there are several different companies offering the technology with variable price range from $300 tp $3000 per balloon.
The issue of concern at present is cost vs benefit. Does it work? And does it work in the long term? These questions have yet not been clearly answered with proper scientific studies and follow-up. The general sense is that if the proper patient is identified, balloon sinuplasty may work well. The ideal patient may be one with a single sinus disease that needs to have that one particular sinus drained. It is felt not to be a good option for those patients where several sinuses are involved and there is pan sinus inflammation.