Sinusitis/Sinus, Allergy Care, Facial Plastic Surgery - Fort Lauderdale/Broward/South Florida

About Balloon Sinuplasty

As in other medical fields, sinus surgery has evolved from open to less invasive surgical techniques. As recently as the 1970's, sinus surgery required external facial incisions and resulted in extensive removal of tissue and mucosa. It was hypothesized that diseased mucosa was the primary cause of the condition and should be removed.

With the advent of Functional Endoscopic Sinus Surgery (FESS), sinus treatment took an evolutionary leap forward. This procedure pioneered the use of endoscopes and surgical instruments, allowing sinus surgery to be performed through the nostrils. During this time, it was discovered that blocked sinus passageways disrupted normal mucociliary flow and were the disease culprit. FESS not only changed how sinus surgery is performed, but defined the goals of sinus surgery that still exist today:

Clear blocked sinuses, restoring normal sinus drainage and function
Preserve normal anatomy and mucosal tissue

While current FESS techniques were a major advancement, the first goal of sinus surgery is sometimes achieved at the expense of the second. Stainless steel tools used in the procedure may make it difficult to access the delicate, tortuous sinus anatomy without removal of tissue and bone.

Balloon Sinuplasty^TM Technology: Novel, endoscopic, catheter-based devices lead to further surgical evolution
Balloon Sinuplasty^TM products are endoscopic, catheter-based devices specifically designed to navigate the tortuous sinus anatomy. The Sinus Balloon Catheter is used to dilate blocked paranasal sinus ostia, and in many cases, without tissue or bone removal. The design of these devices gives the surgeon the opportunity to use novel, endoscopic instruments that achieve both of the goals of sinus surgery.

Overview of the 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:

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 under fluoroscopic guidance.

The Sinus Balloon Catheter tracks smoothly over the Sinus Guidewire and positioned across the blocked ostium. Using fluoroscopy, the position of the Sinus Balloon Catheter is confirmed. It is gradually inflated to gently restructure the blocked ostium.

The Balloon Sinuplasty^TM 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 opening attained by the Balloon Sinuplasty^TM system is durable and achieves the goals of sinus surgery(1). Post-procedure, the size of the dilated opening is approximately that of the nominal diameter of the selected Sinus Balloon Catheter (from 3mm to 7mm).

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.

(1) Data on file at Acclarent, Inc.