Balloon Sinuplasty technology is a surgical option for the treatment of blocked sinuses.

Patients that have been diagnosed with chronic sinusitis and are not responding well to medications may be a candidate for surgery.^[1][2][3][4] Two of the surgical options that patients and their physicians may elect are Balloon Sinuplasty or Functional Endoscopic Sinus Surgery (FESS).

Balloon Sinuplasty technology is an endoscopic, catheter-based system for patients suffering from sinusitis. The FDA-cleared technology^[5] uses a small, flexible, sinus balloon catheter to open up blocked sinus passageways, restoring normal sinus drainage. When the sinus balloon is inflated, it gently restructures and widens the walls of the passageway while maintaining the integrity of the sinus lining.

Contents 1 The Procedure 2 History 3 References 4 Additional Reading

[edit] The Procedure

Sinus surgery with Balloon Sinuplasty is typically performed on an outpatient basis in either a surgical center or hospital setting. Local or general anesthesia can promote patient comfort. Most physicians suggest that their patients opt for either conscious sedation or local or general anesthesia. Because the procedure involves the insertion of balloon catheters, guidewires and other systems such as irrigation catheters, illumination systems and navigation systems into the nose, individuals might become uncomfortable and find it difficult to remain still during the procedure.

The physician inserts the sinus guide catheter into the nostril to gain access to the sinus ostia (passage) under endoscopic visualization. An endoscope allows the physician to easily see through the nasal passages to the sinus cavities to ensure that he/she is inserting the catheter into the proper location. A sinus guidewire or sinus illumination system is then introduced into the targeted sinus via the sinus guide catheter. The sinus illumination system provides a full-strength, targeted fiber optic light transmission that helps the physician to see that he/she has placed the sinus guide catheter in the correct place. Once the access has been confirmed, a balloon catheter (a tiny balloon inside a catheter) is introduced into the sinus cavity via the sinus guidewire or sinus illumination system and positioned in the blocked ostium for inflation. Once the position has been confirmed visually, the balloon is opened to unblock and reshape the narrow or blocked ostium. The balloon is then deflated and removed. Next, an irrigation catheter is advanced over the sinus guidewire or sinus illumination system to flush out the sinus of any mucus or pus. Finally, the sinus irrigation catheter is removed from the sinus to allow the sinus cavity to now freely drain any mucus and/or pus. The linings of the sinus and nasal passages are not disturbed during the procedure and little to no blood is lost.^[6]

[edit] History

Balloon Sinuplasty technology was developed by Acclarent, Inc. The product was launched in 2005, after FDA approval. This technology is one of the first significant innovations in the field of otolaryngology (Ears, Nose and Throat) in more than twenty years. Until the Balloon Sinuplasty procedure, patients underwent FESS as the only sinus surgery option. In comparison, FESS is more invasive and uses rigid instruments. It involves the cutting and removal of bone within the sinus cavities.^[7] The FESS procedure, not only permanently removes bone and tissue, but can lead to a painful recovery. According to the Centers for Disease Control (CDC)^[8], more than 13% of the adult US population suffers from chronic sinusitis. Balloon Sinuplasty offers patients a less invasive option. The pain and bleeding is minimal and there is no swelling or bruising, which leads to a speedier recovery after surgery. Balloon Sinuplasty technology does permanently alter the sinus cavities by re-shaping the bony structure, as opposed to FESS where bone is actually removed. Herein lies the controversy with this procedure, whether leaving bone in an attempt to improve drainage from the sinuses is a good idea or not. There is very limited medical research that would permit surgeons to fully understand the consequences of leaving bone after Balloon Sinuplasy. Patients have the option of more aggressive surgical procedures if necessary or may repeat Balloon Sinuplasty in the future.^[9] Not all patients qualify for this procedure. As with all invasive sinus procedures, there is a small risk of damage to the brain because of its close proximity to the sinuses. In the five years since Balloon Sinuplasty was first used on humans, more than 65,000 patients have been successfully treated with the technology.^[5] Currently, there are more than 4,000 physicians trained on the technology in more than 45 countries, including United States.

[edit] References

[edit] Additional Reading

1. Brown, CL, et al; Safety and Feasibility of Balloon Catheter Dilation of Paranasal Sinus Ostia: A Preliminary Investigation; Annals of Otology, Rhinology & Laryngology April 2006, Vol. 115(4): 293-299

2. Bolger, WE, et al; Catheter Based Dilation of the Sinus Ostia: Initial Safety and Feasibility Analysis in a Cadaver Model; American Journal of Rhinology May-June 2006, Vol. 20, No. 3, P. 290-294

3. Benninger, M., Otolaryngology Head and Neck Surgery 2003; 129S: s1-S32

4. Gliklich, R., et al, Journal of Allergy Clin Immunol 1999; 113: 104-109

5. Ray, N., et al, Journal of Allergy Clin Immunol 1999; 103: 408-414