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CADTH » Search All Products » Environmental Scanning » Health Technology Update » Issue 3, June 2006 » New Sinusitis Treatment May Be a Breath of Fresh Air

New Sinusitis Treatment May Be a Breath of Fresh Air

A minimally invasive procedure for opening blocked sinus passages uses techniques similar to those used in balloon angioplasty to unblock coronary arteries.

How it Works

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A flexible balloon catheter is inserted (Step 1), then inflated (Step 2), to widen the sinus passages.

Photo courtesy of Acclarent Inc.

Performed through the nostrils, a flexible balloon-tipped wire is threaded through the delicate twists and turns of the sinus passages under fluoroscopic guidance. An ear, nose and throat (ENT) surgeon or rhinologist inflates the balloon slightly to gently restructure and widen the sinus walls to restore normal drainage and function.

The procedure dilates the sinus passages by 3 mm to 7 mm, depending on the size of the sinus balloon catheter used.[1]

The one-time outpatient procedure is done under general anesthesia or conscious sedation and takes 30 to 120 minutes, depending on the number of sinus passages to be treated. The same catheter can be used on several sinuses in one patient. Patients can return to normal activities within a day.[1]

Prevalence and Symptoms

Six to seven per cent of Canadians report symptoms of chronic sinusitis,[2] which include:

  • nasal congestion, obstruction and postnasal drainage
  • facial pressure and pain
  • headache
  • fatigue
  • loss of smell and taste

Limitations

People are not candidates for balloon sinuplasty if they have extensive scarring from previous sinus surgery; cystic fibrosis; nasal polyps; sinonasal tumours or obstruction; or ciliary dysfuntion.[3]

Regulatory Status

The Balloon Sinuplasty™ System, manufactured by Acclarent Inc. (Menlo Park, CA), is not yet licensed for use in Canada. The US Food and Drug Administration granted approval in August 2005 for its use in diagnostic and therapeutic procedures of the sinus cavities.

Evidence

In a small feasibility pilot study, no adverse events occurred among 10 patients.[3] Evidence of long-term patency (openness) of the sinus passages is lacking. A multicentre registry (CLEAR) is prospectively collecting data on sinus passageway patency, adverse event rates and quality of life outcomes six months after balloon sinuplasty surgery in 115 patients.[4]

Other Sinus Surgeries

Functional endoscopic sinus surgery (FESS) to remove bone and tissue is the most common surgery for patients with sinusitis who do not respond to medical treatment. Tissue trauma and bleeding with balloon sinuplasty may be less than what is encountered during FESS.[1,3] Balloon sinuplasty may be combined with other sinus surgery techniques.

Cost

The disposable components of the Balloon Sinuplasty System cost approximately US$1,200 per procedure. The System includes the Relieva™ sinus balloon catheter, guide catheter, guidewire, lavage catheter, exchange catheter and the sinus balloon inflation device.

References

[1] Acclarent. Balloon Sinuplasty™ technology. Menlo Park (CA): Acclarent; 2005. Available: http://www.acclarent.com.

[2] Rapoport J, et al. Chronic Dis Can 2004;25(1):13-21. Available: http://www.phac-aspc.gc.ca/publicat/cdic-mcc/25-1/c_e.html.

[3] Brown CL, et al. Ann Otol Rhinol Laryngol 2006;115(4):293-9.

[4] Clinical evaluation to confirm safety and efficacy of sinuplasty in the paranasal sinuses (CLEAR). In: ClinicalTrials.Gov [database online]. Bethesda (MD): National Institutes of Health; 2005. NCT00231062. Available: http://clinicaltrials.gov/show/NCT00231062.