Sinusitis affects 39 million people each year^1,2, making it one of the most common health problems in the U.S. It impacts a patient's quality of life³ and accounts for over $8 billion* in annual healthcare expenditures⁴.

Two approaches have emerged for treating these patients:


Advancing Sinusitis Treatment
Medical therapies have advanced from basic remedies to an array of specialized drugs and sophisticated delivery methods. These treatments are often effective in reducing sinusitis symptoms. However, for many patients, these medications are inadequate and surgery may be their next step in finding relief.

Sinus surgery has also evolved from open to less invasive surgical techniques. With the advent of FESS in the 1980s, surgery took an evolutionary leap forward with the elimination of open surgery, the introduction of endoscopic tools, and the discovery that blocked sinus ostia may be the primary culprit of this disease.

Achieving the Goals of Sinus Surgery
Balloon Sinuplasty^TM technology extends the sinus surgery evolution by offering the surgeon additional tools for endoscopic surgery. The Relieva Balloon Sinuplasty^TM products are catheter-based devices designed to assist otolaryngologists in further meeting their surgical goals of clearing blocked sinuses, restoring normal sinus drainage and function, and preserving normal anatomy and mucosal tissue.

Utilization Overview: The Relieva Balloon Sinuplasty^TM System
A trained otolaryngologist determines that it is appropriate to use the Balloon Sinuplasty^TM system.

Steps in using these devices are:

Gain Access to the Sinus. To gain initial sinus access, a sinus guide catheter is introduced into the nasal cavity to target the sinus ostia under endoscopic visualization. A sinus guidewire or a sinus illumination system is introduced through the sinus guide catheter and gently advanced into the target sinus.		Inflate Balloon Across Ostium. The sinus balloon catheter is introduced over the sinus guidewire or sinus illumination system and positioned across the blocked ostium. The position of the sinus balloon catheter is confirmed and the balloon is gradually inflated to open and remodel the narrowed or blocked ostium.		Deflate and Remove Balloon. The sinus balloon catheter is then deflated and removed, leaving the ostium open allowing the return of normal sinus drainage and function. There is little to no disruption to mucosal lining.

The opening attained by the Balloon Sinuplasty^TM system is durable and achieves the goals of sinus surgery.⁵

Applications
The Balloon Sinuplasty^TM devices are effective endoscopic tools and may be used with other medical therapies or FESS techniques. In a patient, the Balloon Sinuplasty^TM products can be used on several sinuses. Additionally, using these devices should not limit future treatment options for patients with progressive disease.

Each patient suffering from sinusitis is different. Only after thorough examinations and discussions between the patient and a qualified otolaryngologist can it be determined whether a patient may benefit from the Balloon Sinuplasty^TM system.

* Inflation adjusted

1. National Health Interview Survey, 2005.

2. Benninger, M. Otolaryngol Head Neck Surg 2003; 129S: S1-S32.

3. Gliklich, R., et al, J. Allergy Clin Immunol 1999; 113: 104-109.

4. Ray, N., et al, J. Allergy Clin Immunol 1999: 103: 408-414.

5. Bolger, W., et al, Otolaryngol Head Neck Surg 2007; 137: 10-20.