Balloon Sinuplasty™ Technology

Sinusitis affects 37 million people each year,1,2,3 making it one of the most common health problems in the
U.S. It impacts a patient's quality of life4 and accounts for over $8 billion* in annual health care
expenditures.5

Two approaches have emerged for treating these patients:

1. Medical therapies
2. Endoscopic interventions

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™ technology extends the sinus surgery evolution by offering the surgeon additional tools
for endoscopic surgery. The Relieva Balloon Sinuplasty™ 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™ System

A trained otolaryngologist determines that it is appropriate to use the Balloon Sinuplasty™ system.

Steps in using these devices are:

To gain initial sinus access, the
Sinus Guide Catheter is introduced
into the target sinus under
endoscopic visualization. A flexible
Sinus Guidewire is introduced
The Sinus Balloon Catheter tracks
smoothly over the Sinus
Guidewire and positioned across
the blocked ostium. It is gradually
inflated to gently restructure the
The Balloon Sinuplasty™ system is
removed, leaving the ostium open
and allowing the return of normal
sinus drainage and function. There
is little to no disruption to mucosal
through the Sinus Guide Catheter blocked ostium. lining.
and gently advanced into the target
sinus.

The Balloon Sinuplasty™ system creates a durable opening and assists otolaryngologists to achieve the
goals of sinus surgery.6 Post-procedure, the size of the dilated opening is approximately that of the nominal
diameter of the selected Sinus Balloon Catheter (from 3.5mm to 7mm).

Applications
The Balloon Sinuplasty™ devices are effective endoscopic tools and may be used with other medical
therapies or FESS techniques. When applied in the same patient, the Balloon Sinuplasty™ 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™ system.

* Inflation adjusted
1. National Health Interview Survey, 2006.
2. US Census 2007.
3. Lusk, R., et al, Laryngoscope 2006; 116: 2099-2107.
4. Gliklich, R., et al, J. Allergy Clin Immunol 1999; 113: 104-109.
5. Ray, N., et al, J. Allergy Clin Immunol 1999: 103: 408-414.
6. Weiss, R., et al, Otolaryngol Head Neck Surg 2008; 139: S38-S46.