THE PILLAR® PROCEDURE

Pillar Implant

THE PILLAR® PROCEDURE
Frequently Asked Questions

What is the Pillar Procedure?

The Pillar Procedure is an effective, first-line palatal 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.

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 structure of the soft palate to help reduce both the vibration that causes snoring and the ability of the soft palate to obstruct the airway during sleep.

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.

How long does the procedure take?

The procedure takes one, short visit to the physician’s office.

How does the Pillar Procedure differ from other treatments?

There are several key differences:

Minimally invasive 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. Many patients report a noticeable improvement within 6 to 9 weeks, and because the implant is designed to be permanent they have the potential of experiencing a lasting effect.

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 snoring or sleep apnea and if you are a good candidate for the Pillar Procedure.

What kind of results can I expect?

Most patients report a noticeable and lasting reduction in snoring.
Some patients see improvement within 6 to 9 weeks, while others take up to three
months to realize the full benefit of the Pillar Procedure. In long-term (one year)
clinical studies, sleep apnea was reduced in 81% of patients; for patients suffering
from disruptive snoring, sleep partner satisfaction ranged from 67% to 100%.

Patients also experienced less daytime sleepiness.

How long does the effect last?

Is it permanent?

The inserts are designed to be permanent and to provide a long-lasting effect. Once in place the inserts cause a natural tissue response, which secures them within the palate. The stiffening of the palate changes its response to airflow. Our clinical studies show that patient and sleep partner satisfaction with the procedure remain high after one year.

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. The physician places each insert into the soft palate using a specially designed delivery tool. The palate tissue is not removed.

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.

Will I notice the inserts in my palate?

You should not be able to 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 should subside after a short time.

Will there be any change in my voice or
will I have any difficulty swallowing?

Physicians have not reported that patients have experienced and long-term changes in voice or difficulty swallowing.

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 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 fewer than 1% reported partial extrusions.

Can the inserts be removed?

Yes. An insert can be removed in the physician’s office with a simple procedure. A patient can also have a new insert placed at the time of removal.

How much does it cost?

The cost for the procedure includes both the physician’s fees as well as the cost of the three implants. Our office charges $2000 for the entire procedure.

Does my insurance cover the Pillar Procedure?

The treatment of snoring generally is not a condition that health insurance companies cover. Most health insurance policies cover certain procedures and treatments for obstructive sleep apnea. However, many health insurance companies do not yet cover the Pillar Procedure for the treatment of obstructive sleep apnea. Our office staff will review your insurance and help determine if the Pillar Procedure may be covered for you.

How many people are affected by disruptive
snoring and sleep apnea?

According to a report published in the April 2004 Journal of the American Medical Association, approximately 44 million people in the United States suffer from mild OSA and approximately 15 million people suffer from moderate or more severe OSA. In a separate report, the American Academy of Otolaryngology estimates that approximately 55 million people suffer from habitual snoring. Because most people who have OSA snore, the number of people with OSA overlaps significantly with the number of people who snore.

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 such as 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.

For additional information visit
www.pillarprocedure.com

For Questions or to Schedule an Appointment
Call:
Aaron Spingarn, M.D.
914.686.3950