>> Sinus Surgery and Balloon Sinuplasty
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| Sinus Surgery and Balloon Sinuplasty |
Sinus Surgery is commonly performed in those patients who suffer from recurrent or chronic sinus disease (usually infections) who have not responded to medical treatment.
Currently almost all sinus surgery is performed using minimally invasive techniques commonly referred to as FESS which stands for functional endoscopic sinus surgery. FESS is performed with the patient asleep under general anesthesia using endoscopes (small rigid telescopes) to access the sinuses through the nose without the need for external incisions. Utilizing this approach all the sinuses can opened and the normal drainage pattern restored with minimal disruption of normal tissue. This minimalist approach shortens healing time and postoperative discomfort. In the last few years an even less invasive technique has been developed which utilizes a tough micro balloon placed across the sinus opening to dilate and open the sinus. Aside from infectious problems these techniques can also be used to remove some nasal tumors and repair blocked tear ducts.

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| Relieva Balloon Sinuplasty™ Overview |
Sinusitis Overview
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 arthritis and hypertension and has a greater impact on quality of life than diabetes or congestive heart failure. Symptoms may significantly affect people physically, functionally, and emotionally.1,2,3
1. National Institute of Allergy and Infectious Diseases.
2. National Academy on Aging Society.
3. Benniger, M. Otolarngoly Head Neck Surg 2003; 1295: 51-532.
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Facts About Sinusitis
• Sinusitis affects approximately 16% of the adult U.S. population.
• Sinusitis affects 21% of women and 16% of men each year.
• Chronic sinusitis (not including acute sinusitis) results annually in an estimated 18-22 million physician office visits.1
• Patients with chronic sinusitis have twice as many visits to primary care doctors and five times as many pharmacy fills as patients who do not have it.
• Direct healthcare expenditures due to sinusitis cost are well over $8 billion each year.*
• Total restricted activity days due to sinusitis are well over 73 million per year.
1. National Institute of Allergy and Infectious Diseases.* Inflation Adjusted
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The Role of the Sinuses
To understand sinusitis, it is important to first learn about your sinuses and their role with your health.
• The sinuses are air spaces behind the bones of the upper face, between the eyes and behind the forehead, nose and cheeks. The sinuses are covered with a mucus layer and cells that contain little hairs on their surfaces called cilia. These help trap and push out bacteria and pollutants.
• Each sinus has an opening that allows mucous to drain – this drainage is essential to keeping your sinuses working well and you healthy. Anything that obstructs that flow may cause a buildup of mucus in the sinuses.
• Experts agree that healthy sinuses are a key to a good quality of life and that unhealthy sinuses may cause some unwanted complications

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What Are My Treatment Options?
• Chronic sinusitis symptoms can make you miserable and impact your quality of life. In order to get relief, you need to make the right treatment decision with your doctor.

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Medical Therapy
• Sinusitis is typically treated first with medication. Treatment with antibiotics or topical nasal steroid sprays is often successful in reducing mucosal swelling, fighting infection, and relieving obstructions of the sinus opening (ostium). Inhaling steam or use of saline nasal sprays or drops can also help relieve sinus discomfort. However, an estimated 20-25% of patients do not respond adequately to medications.1
1. Hamilos, J Allergy Clin Immunol 2000; 106: 213-27.
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Conventional Sinus Surgery
• The goals of sinus surgery are to clear blocked sinuses restoring normal sinus drainage and function and to preserve normal anatomy and mucosal tissue. Conventional sinus surgery is called Endoscopic Sinus Surgery (ESS). With ESS, specialized instruments are placed into the nose along with a small endoscope to help the surgeon see inside the nose and nasal cavities.
• The procedure works by removing bone and tissue to enlarge the sinus opening. The removal of bone and tissue may lead to post-operative pain, scarring, and bleeding. Uncomfortable nasal packing may be required to control the bleeding. ESS procedures result in an 80-90% success rate in relieving patient symptoms.1,2
1. Levine and Clemente, Sinus Surgery - Endoscopic and Microscopic Approaches, Thieme 2005, p. 260.
2. Josephson JS, Med Clin of North Amer 75: 1293-1309; 1991.
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Relieva Balloon Sinuplasty™ Technology
The Relieva Balloon Sinuplasty™ Technology: Novel, Endoscopic, Catheter-Based Devices
• This technology utilizes a small, flexible, sinus balloon catheter that is placed into the nose to reach the sinuses. The sinus balloon catheter is gradually inflated to gently restructure the previously blocked nasal passage, maintaining the integrity of the sinus lining and restoring normal sinus drainage and function. There is minimal bleeding, and many patients have been able to return to normal activities within 24 hours.1 Clinical studies have indicated that the Relieva Balloon Sinuplasty™ system is a safe and effective tool in dilating blocked sinuses. 2
1. Data on file at Acclarent, Inc.
2.Bolger, W. et al. “Safety and outcomes of balloon catheter sinustomy: a multi center 24-week analysis in 115 patients.” Otolaryngology – Head and Neck Surgery. 2007, 137: 10 – 20.
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Relieva Balloon Sinuplasty™ 3D Animation
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Technology Overview
• Relieva Balloon Sinuplasty™ devices provide an endoscopic, catheter-based system for patients suffering from sinusitis. Recently published data in the leading ENT journal shows that the technology is safe and effective: study participants experienced no adverse events and received significant relief from their symptoms. 1
• Relieva Balloon Sinuplasty™ technology is used by qualified Ear, Nose, and Throat (ENT) physicians and involves the use of tiny balloons to open blocked sinuses similar to how angioplasty uses balloons to open blocked coronary arteries.
1. Bolger, W. et al. “Safety and outcomes of balloon catheter sinustomy: a multi center 24-week analysis in 115 patients.” Otolaryngology – Head and Neck Surgery. 2007, 137: 10 – 20.
The diagram below shows an inflamed left frontal and maxillary sinus
• In order to improve symptoms of chronic sinusitis, an ENT physician will use Relieva Balloon Sinuplasty™ devices to open the blockage that is preventing sinus drainage.
• The following picture summarizes the steps associated with using the Relieva Balloon Sinuplasty™ technology in the frontal sinus:

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Relieva Balloon Sinuplasty™ Benefits
The benefits of Relieva Balloon Sinuplasty™ technology for treating chronic sinusitis symptoms include: • Safe and Effective
While use of any surgical instrument involves some risk, clinical studies have indicated the Relieva Balloon Sinuplasty™ system to be safe and effective in relieving symptoms of sinusitis.
• Minimally Invasive
The technology uses small, soft, flexible devices that enter entirely through the nostrils. These devices gently open blocked sinus openings, and in many cases, without tissue or bone removal.
• Reduced Bleeding
Because in many instances no tissue or bone is removed when using this technology, there may be reduced bleeding associated with the procedure.
• Improved Recovery Time
While recovery time varies with each patient, many people can return to normal activities within 24 hours.
• Does Not Limit Treatment Options
This technology is an endoscopic tool and may be used with other medical therapies or sinus surgery techniques. It does not limit future treatment options if you have progressive disease.
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How Do Patients Feel? Video
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