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Frequently Asked Questions

What is the Pillar Procedure?
How does the treatment work?
Is it painful?
How long does the procedure take?
How does the Pillar Procedure differ from other treatments?
How do I know if the Pillar Procedure will work for me?
What kind of results can I expect?
How long does the effect last? Is it permanent?
How are the inserts placed in the soft palate?
How big is the insert? What does it look like?
Will I notice the inserts in my palate?
Will there be any change in my voice or will I have any difficulty swallowing?
What kind of complications have you seen?
Can the inserts be removed?
How much does it cost?
What is the reimbursement for the procedure?
How many people are affected by sleep apnea and disruptive snoring?
What are the risks if I choose not to have my sleep apnea treated?

 
What is the Pillar Procedure?
The Pillar Procedure is a simple, effective, first-line treatment for obstructive sleep apnea (OSA) and socially disruptive snoring. Known by the medical term “palatal restoration,� the procedure only takes a single, brief visit to the physician’s office. After first numbing the area with a local anesthetic, your physician embeds three tiny inserts in your soft palate using a specially designed delivery tool. The inserts cause a stiffening effect in the palate tissue to prevent vibration (snoring) and obstruction (OSA) of the airway during sleep. top



How does the treatment work?
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 obstructs breathing. It can also cause the soft palate to vibrate or undulate, causing snoring sounds. (Studies estimate that nearly 80% of all sleep apnea and snoring may be caused either entirely or in part by the soft palate.) The inserts stiffen the soft palate, reducing its vibration and ability to obstruct the airway during sleep. top



Is it painful?
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. top



How long does the procedure take?
The procedure takes one, short visit to the physician’s office.top



How does the Pillar Procedure differ from other treatments?
There are several key differences:

Simple treatment. The treatment is done in one brief office visit. Some other treatments require a series of visits or an operating room procedure.
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.
Results. Most patients report a noticeable improvement within 4 to 6 weeks, and because the implant is designed to be permanent they have the potential of experiencing a lasting effect. top


How do I know if the Pillar Procedure will work for me?
Success with the Pillar Procedure can be influenced by tongue position, tonsil size and other factors. Your doctor will do a physical exam to determine if your palate is the likely cause of your sleep apnea or snoring and if you are a good candidate
for the Pillar Procedure. top



What kind of results can I expect?
Short-term results show that most patients experience an improvement within 4 to 6 weeks. Most patients report a noticeable and lasting reduction in snoring. In nearly 80% of patients in a clinical study, the severity of sleep apnea was reduced. More than 80% of sleep apnea patients—and their bed partners—would recommend the Pillar Procedure. top



How long does the effect last? Is it permanent?
The inserts are designed to be permanent and the effect of the treatment is designed to be long-lasting because of the effect of fibrosis. This natural tissue response stiffens the palate and changes its response to airflow. Our clinical studies show that patient and sleep partner satisfaction with the procedure remain
high after one year. top



How are the inserts placed in the soft palate?
Each patient receives three Pillar inserts. The inserts are preloaded into a specially designed 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 delivery tool into the soft palate. The Pillar insert is left embedded in the soft palate tissue and the delivery tool is removed. The palate tissue is not cut or removed. top



How big is the insert? What does it look like?
Each highly engineered, tiny woven Pillar insert is approximately 18 mm (0.7 inches) in length and has an outer diameter of approximately 2 mm (0.08 inches). The inserts are woven from a polyester material that has been used for more than 50 years in implantable medical products. 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 time. top



Will there be any change in my voice or will I have any difficulty swallowing?
Physicians have not reported that patients have experienced any long-term changes in voice or difficulty swallowing. top



What kind of complications have you seen?
Since the procedure does not involve removing or damaging tissue, the risk of complication is extremely low. There have been 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 US, there have been fewer than 1% reported partial extrusions. top



Can the inserts be removed?
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. top



How much does it cost?
The physician establishes the procedure cost to the patient. You can locate physicians who offer the Pillar Procedure by using the Find a Physican feature of our web site. top



What is the reimbursement for the procedure?
The diagnosis and treatment of sleep apnea is traditionally reimbursed. Restore Medical, the manufacturer of the Pillar Procedure, is actively working with both government and private payers (insurance companies and others) to secure coding for the Pillar Procedure. Currently, insurers will make a case-by-case decision whether or not to cover the procedure. top



How many people are affected by sleep apnea and disruptive snoring?
It is estimated that more than 40 million Americans suffer from some form of sleep-disordered breathing. Of these, more than 12 million suffer from some form of sleep apnea. top



What are the risks if I choose not to have my sleep apnea treated?
Because of the serious disturbances in their normal sleep patterns, people with sleep apnea often feel very sleepy during the day and their concentration and daytime performance suffer. The consequences of untreated sleep apnea range from annoying to life-threatening. They include symptoms suggesting depression,
irritability, sexual dysfunction, learning and memory difficulties, and falling asleep while at work, on the phone, or driving. Untreated sleep apnea patients are at least 3 times more likely to have automobile accidents. Additionally, it has been estimated that up to 50% of sleep apnea patients have high blood pressure. Also, risk for heart attack and stroke may also increase in those with sleep apnea.