Balloon Sinuplasty Technology and Treatments
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 through the Sinus Guide Catheter and gently advanced into the target sinus.
The Sinus Balloon Catheter tracks smoothly over the Sinus Guidewire and positioned across the blocked ostium. It is gradually inflated to gently restructure the blocked ostium.
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 lining.
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).
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.