Sinusitis affects 37 million people each year,making it one of the most common health problems in the U.S. It is more prevalent than heart disease and asthma and has a greater impact on one’s quality of life than chronic back pain or congestive heart failure.

Sinusitis is defined as an inflammation of the sinus lining, and is commonly caused by structural issues such as ostial blockage, bacterial infections, viral infections or a combination of these. For many patients, symptoms vary and may include nasal congestion, facial discomfort, nasal discharge, headache and fatigue. Sinusitis is considered acute when symptoms last 4 weeks or less and chronic when it lasts 12 weeks or longer.

A Significant Unmet Clinical Need
Each year approximately 900,000 patients are left living with their sinus condition.These patients may not find adequate relief from medical therapy and are candidates for surgery, but for a variety of clinical or personal reasons choose not to undergo ESS using existing surgical instruments.

Treatment Options
The most common treatments for sinusitis aim to reduce mucosal swelling and relieve obstructions within the sinus ostium and ostio-meatal region, and include:

  • Medical therapy with antibiotics
  • Topical nasal steroid spray
  • However, at least 20 percent of patients do not respond adequately to medications.

For patients who have failed medical therapy, Endoscopic Sinus Surgery (ESS) is often the next step toward finding relief. During ESS, surgical instruments are used to remove small amounts of bone, tissue or growth blocking the sinus openings. Often, this removal of bone and tissue can require uncomfortable nasal packing after surgery and lead to post-surgery pain and scarring.

Balloon Sinuplasty

Balloon Sinuplasty technology contributes to the sinus surgery evolution by offering a 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.

The Balloon Sinuplasty System creates a durable opening and assists Otolaryngologists in achieving the goals of sinus surgery.

The following diagram outlines the Balloon Sinuplasty procedure:

Balloon Sinuplasty Benefits​:​

  • The Balloon Sinuplasty devices are endoscopic tools that may be used with other medical therapies or ESS techniques. Using these devices should not limit future treatment options for patients with progressive disease.
  • Balloon Sinuplasty is also available as a procedure conducted in the physician’s office under local anesthesia, allowing some patients to avoid the hassles of surgery in an operating room.

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Pediatric Balloon Sinuplasty

Pediatric rhinosinusitis is common but sometimes overlooked. Pediatric patients are often subject to other disease entities which may have a significant overlap with symptoms associated with pediatric Chronic Rhinosinusitis (CRS).

Symptom overlap examples include:

  • Allergic rhinitis
  • Recurrent viral URI
  • Chronic adenoiditis
  • ET dysfunction

​Currently there is a lack of evidence for antibiotic efficacy in chronic sinusitis.​ ​Adenoidectomy failure rate is 40-60% when used as a sole Chronic Rhinosinusitis (CRS) surgical treatment.

The result is a considerable loss of school time and accumulation of medical expenses, affecting children and their parents.

Balloon Sinuplasty, Safe and Effective for Children Suffering from Chronic Sinusitis

Adenoidectomy with Balloon Sinuplasty and lavage of the maxillary sinus may be an appropriate surgical therapy for children deemed to have failed medical treatment.

Multiple studies have demonstrated long-term success of 80-87% with adenoidectomy or after failed adenoidectomy.

In one study, a higher percentage of children’s SN-5 sinonasal symptoms were improved at 12 months, in the Balloon Sinuplasty and adenoidectomy group (80%) compared to the group that underwent adenoidectomy alone (53%).

*Patients were not randomized between the Balloon Sinuplasty and adenoidectomy group and the adenoidectomy alone group. Therefore, the results may be due to different patient characteristics rather than the procedure performed.

Acclarent’s Balloon Sinuplasty Systems (RELIEVA® SPIN, ULTIRRA®, and SOLO PRO™) are indicated for children aged 17 and under and are intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

Balloon Sinuplasty is an Effective Option After Failed Adenoidectomy
In a tertiary care, university affiliated pediatric institution, a side-by-side post-operative comparison of patients who underwent Balloon Sinuplasty with ethmoidectomy or ESS after failed adenoidectomy was conducted. Although the difference was not statistically significant, 62.3% of ESS patients and 80% of Balloon Sinuplasty patients reported improvement in their overall sinus symptoms post-operatively.​
​**Patients were not randomized between the Balloon Sinuplasty and ESS group. Therefore, the results may be due to different patient characteristics rather than the procedure performed.

Airway Stenosis

Airway stenosis is a congenital or acquired narrowing that obstructs the passage of air to the lungs. Symptoms include stridor, wheezing, hoarseness, shortness of breath and respiratory distress. Patients who have severe airway stenosis are often dependent on a tracheotomy tube to breathe.

The most common cause of acquired airway stenosis is endotracheal intubation, resulting in 90% of cases.1 Other causes include external trauma, thermal or caustic injuries, chronic inflammatory diseases, infection, and cancer.

Treatment Options
Treatment options range from endoscopic techniques to open surgical procedures. Open surgical procedures involve either increasing the diameter of the stenosed segment with a graft or stent (expansion surgery) or removal of the stenotic area (resection surgery).

Endoscopic techniques may involve the use of instruments to incise and dilate the stenosis. Traditional methods of airway dilation have involved rigid bougies that can impart shear forces and mucosal injury. The recent development of balloon technology for airway dilation enables controlled radial pressure to be applied at the site of stenosis.

INSPIRA AIR® Balloon Dilation System: A minimally invasive solution for airway management​.​

The INSPIRA AIR® Technology is designed to safely dilate airway strictures such as in the trachea and upper bronchi with minimal mucosal trauma. These devices are endoscopic tools and may be used with other endoscopic techniques or adjuvant therapies.

Unlike traditional rigid dilators, the INSPIRA AIR® Technology applies controlled radial pressure to a stricture through precise inflation and pressure regulation.

The low profile system and soft seeker tip provide a​​traumatic access.

The following diagram outlines the balloon dilation process:







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