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What is the Pillar System procedure and how does it work? What is the Pillar System procedure and how does it work? The procedure, called Palatal Restoration, takes about 10 minutes in the office. After first numbing the area with a local anesthetic, the doctor embeds three tiny Pillar™ System inserts in your soft palate using a specially designed delivery tool. The inserts are designed to be permanent; they cause a stiffening effect in the palate tissue that reduces the vibration that causes most palatal snoring. Back to Top How does the treatment reduce snoring? As throat muscles relax during sleep, unsupported tissues in the back of the mouth and the throat may stretch and collapse. This reduces the size of the airway and causes the soft palate to vibrate or undulate, causing snoring sounds. Studies estimate that up to 90% of all snoring may be caused either entirely, or in part, by the soft palate. The Pillar inserts stiffen the soft palate, reducing its vibration during sleep, much like struts in an airplane wing. Back to Top Because tissue is not removed or damaged, discomfort is minimal. Some patients use an over the counter pain reliever after the procedure and most are able to resume normal activities and diet the same day. Back to Top How long does the procedure take? The total procedure takes approximately 10-15 minutes in the office. Back to Top Since you are not removing tissue why does it work? The procedure restores the physical integrity of the palate; reducing its vibration during sleep, much like struts in an airplane wing. Back to Top How many patients have been treated in the US? More than 600 patients were treated in the US in 2003, and this number continues to grow each day. Back to Top What clinical trials have been done on the product? We conducted clinical trials treating over 120 patients in 3 countries for two years before launching the product in the U.S. in early 2003. Back to Top Will the Pillar System work for me? The Pillar System works by stiffening the palate and reducing palate tissue vibration during sleep. Palatal vibration is often a major contributor to snoring. The doctor will do an exam to determine if your palate is the likely cause of your snoring and if you are a good candidate for the Pillar™ treatment. Back to Top What kind of results can I expect? Short term results show that most patients experience a reduction in their snoring within 4 to 6 weeks and see continued improvement up to 90 days. Back to Top How long does the effect last? Is it permanent? The insert is designed to be permanent and the effect of the treatment is designed to be long-lasting because the insert causes a long-term effect of fibrosis, or scarring. This effect stiffens the palate and changes its response to airflow. Our clinical studies show that patient and bed partner satisfaction with the procedure remain high after 1 year. Back to Top How will I feel after the procedure? Patients report that the procedure causes minimal discomfort. Some take a mild pain reliever after the anesthetic wears off, and most are able to resume normal diet and activities the same day or the following morning. Back to Top Will I notice the inserts in my palate? You will not see the inserts in your palate. A small percentage of patients report feeling a minor foreign body sensation after the procedure. This sensation is temporary and subsides after a short period of time. Back to Top Will there be any change in my voice or will I have any difficulty swallowing? No. Patients have not reported any changes in voice or difficulty swallowing. Back to Top What kind of complications have you seen? Since the procedure does not involve removing or damaging tissue, the risk of complications is extremely low. We have had no reported major adverse events. Minor complications have consisted of partial extrusions that have been readily resolved by the physician simply removing the insert. A partial extrusion occurs when the tip of the insert can be felt or seen through the surface of the palate tissue. Most patients request to have the insert replaced because they were pleased with the results. Since launching the product in the U.S., there have been less than 1% reported partial extrusions through 90 days. Back to Top How does Palatal Restoration differ from other treatments? There are several key differences: 1. Simple treatment - The treatment is done in one brief office visit; some other treatments require a series of visits or an operating room procedure. 2. Minimal Discomfort -Palatal Restoration does not require chemical agents, heating or removing tissue. Therefore the procedure causes minimal discomfort and most patients resume normal diet and activities the same day. 3. Results- Most patients report a noticeable improvement in snoring within 4-6 weeks, and because the implant is designed to be permanent they have the potential of experiencing a lasting effect. Back to Top How are the inserts placed in the soft palate? Each patient receives 3 Pillar inserts. The Pillar inserts are preloaded into a specially designed hollow needle portion of the delivery tool. Each insert and its delivery tool are provided in a sterile package to the physician. To place each insert, the physician inserts the needle into the soft palate. The Pillar insert is left embedded in the soft palate tissue and the needle is removed. The palate tissue is not cut or removed. Back to Top How big is the insert? What does it look like? Each highly engineered, tiny woven Pillar insert is approximately 18.0 mm (0.7 inches) in length and has an outer diameter of 2 mm (0.08 inches). The inserts are woven from a polyester material that has been used for many years in implantable medical products. During the Palatal Restoration procedure, each patient receives three inserts embedded in the soft palate. Back to Top Can the inserts be removed? How? Yes. An insert can be removed in the physician's office with a simple procedure with no special surgical tools. A patient can also have a new insert placed at the time of removal. Back to Top Can it be used on people with sleep apnea? Current FDA clearance is for snoring only, however clinical trials are underway to assess the Pillar System's effectiveness in treating patients with obstructive sleep apnea. Back to Top What is the reimbursement for the procedure? The Pillar System is currently indicated for the treatment of snoring only. Insurance companies and Medicare currently do not reimburse for any snoring procedures. Back to Top Is snoring really such a bad problem? Snoring can affect bedroom harmony and may cause daytime sleepiness and irritability. And it is a common problem. Everyone knows friends and loved ones with snoring problems, and the issues it causes in their relationships. Furthermore, there is an increasing body of evidence linking sleep disorders (both snoring and sleep apnea) to long-term health problems such as hypertension and stroke. Back to Top Is snoring merely an inconvenience or a real health problem? We believe it is both. Snoring can affect bedroom harmony and may cause daytime sleepiness and irritability. Furthermore, recent studies have begun to see a link between snoring and long-term health issues such as hypertension and risk of stroke. Back to Top How many people are affected? It is estimated that more than 40 million Americans suffer from some form of sleep-disordered breathing. Of these, over 20 million are primary snorers, and the balance suffers from some form of sleep apnea. Back to Top Who makes the Pillar System and developed the procedure? The Pillar Palatal Implant was developed by Restore Medical. Established in 1999, Restore Medical is a privately-held company focused on becoming the primary resource for doctors specializing in sleep and breathing disorders. Restore Medical has developed and markets proprietary implant technology which addresses such disorders as snoring and sleep apnea. The company's first product based on this technology, the patented Pillar System, received market clearance from the Food and Drug Administration in late 2002 and is currently available throughout the United States. Located in St. Paul, Minnesota, Restore Medical manufactures the Pillar System in its onsite state-of-the-art Class 100,000 Clean Room. The company is ISO 9001 certified and utilizes an intranet-based quality and product development system. BACK TO MAIN PAGE ABOUT SNORING ©2004 Reproduced with the permission of Restore Medical. |
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