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FDA Clears First Implantable Medical Device Treatment for 12 Million Americans Who Suffer with Sleep Apnea.



ST. PAUL, Minn. -- Pillar(R) Procedure offers less painful, less risky, first-line alternative for treating this serious medical condition; Helps patients get a good night's sleep

Imagine if you stopped breathing in the middle of the night. Now, imagine doing that hundreds of times a night. According to the American Sleep Apnea Association The American Sleep Apnea Association (ASAA) is a non-profit organization founded in 1990 by persons with sleep apnea and concerned health care providers and researchers. ASAA Mission , that's what more than 12 million Americans suffer from each evening. It's called sleep apnea sleep apnea, episodes of interrupted breathing during sleep. Obstructive sleep apnea is a common disorder in which relaxation of muscles in the throat repeatedly close off the airway during sleep; the person wakes just enough to take a gasping breath. , a serious health condition causing constant interruptions from sleep and depriving sufferers from the benefits of deep sleep. For the first time, patients with sleep apnea can avoid painful surgery and uncomfortable, life-long treatment options such as CPAP CPAP
abbr.
continuous positive airway pressure


Continuous positive airway pressure (CPAP)
A ventilation device that blows a gentle stream of air into the nose during sleep to keep the airway open.
 through a simple, one-time, minimally-invasive, in-office procedure.

Restore Medical today announced that it has received U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) 510(k) clearance to market the company's Pillar Procedure, the first FDA-cleared implantable treatment for Obstructive Sleep Apnea Obstructive sleep apnea (OSA)
A potentially life-threatening condition characterized by episodes of breathing cessation during sleep alternating with snoring or disordered breathing.
 (OSA 1. OSA - Open Scripting Architecture.
2. OSA - Open System Architecture.
).

OSA, the most common form of sleep apnea, is caused by a blockage of the airway, often when the soft tissue in the rear of the throat collapses and closes during sleep. As a result, people with untreated sleep apnea stop breathing repeatedly and may wake up 20 to 30 times per hour during the night. The most common symptoms for sufferers are snoring snoring, rough, vibratory sounds made in breathing during sleep or coma. The noisy breathing is the result of an open mouth and a relaxation of the palate; it is frequently induced by lying on one's back.  and fatigue. They are also often less productive at work and are actually three times more likely to have automobile accidents. In addition, sleep apnea is a serious health disorder that has been linked to heart disease, high blood pressure, stroke, memory problems, weight gain, impotency and headaches.

As the first FDA-cleared implantable treatment for mild to moderate sleep apnea, the Pillar Procedure is designed to restore or stiffen the palate, a contributor in nearly 80 percent of patients suffering from sleep and breathing disorders. The procedure places three inserts in the patient's soft palate soft palate
n.
The movable fold, consisting of muscular fibers enclosed in mucous membrane, that is suspended from the rear of the hard palate and closes off the nasal cavity from the oral cavity during swallowing or sucking.
, causing the palate to stiffen. The stiffening helps to prevent or lessen blockages of the airway - effectively treating sleep apnea. Pillar inserts are less than one inch long and made from a woven soft polyester material that has been used for many years in implantable medical products. The Pillar Procedure is conducted in a single, short, in-office setting using local anesthetic and is completely reversible. Most patients report that the procedure is virtually painless and that they are able to resume normal activities and diet the same day.

"The Pillar Procedure offers an incredible advance for the treatment of OSA. For the first time, physicians are now able to provide patients with a one-time, minimally-invasive, in-office procedure to effectively treat sleep apnea," said Restore Medical President and Chief Executive Officer Susan L. Critzer. "We've already experienced great success with Pillar for treating snoring and are confident we will expand this success as we continue to deliver physicians and patients innovative sleep and breathing disorder therapies."

"Individuals suffering from sleep apnea often go untreated, as they're either unaware they have the condition, or have misgivings about traditional treatments available," said Michael Friedman, MD. "New breakthrough therapies like the Pillar Procedure offer patients a promising first-line treatment option with minimal pain, recovery-time and risk. If apnea is treated early-on, like any other disease, the chance for recovery from negative health consequences increases. The Pillar Procedure is helping not only provide an attractive alternative treatment, but is also helping to increase overall awareness of sleep apnea and the seriousness of the condition."

Pillar Delivers Effective Treatment with Less Risk, Pain and Recovery Time

Existing palate-related OSA conditions have been treated through a "life-long" therapy approach of wearing an air mask that applies continuous positive airway pressure continuous positive airway pressure
n.
Abbr. CPAP A technique of respiratory therapy for individuals breathing with or without mechanical assistance in which airway pressure is maintained above atmospheric pressure throughout the
 (CPAP), the irreversible surgical removal of tissue (uvulopalatopharyngoplasty, laser-assisted uvulopalatoplasty) or scarring and burning of tissue (radiofrequency ablation), both of which require ongoing treatments. The more invasive surgical treatments or therapies have historically shown variable success rates, low compliance rates, increased risks associated when used with general anesthetic, increased post-operative pain, and unwanted side effects. When compared to existing palatal pal·a·tal
adj.
Palatine.


palatal (pal´t
 treatment options, The Pillar Procedure offers:

--A less invasive, fully-reversible treatment approach with satisfaction ratings equivalent or better than surgical treatment options

--Low complication rates - less than one percent

--Less recovery time, with fewer follow up visits

--Lower overall treatment costs

"The science behind the study of sleep - and its impact on overall health - is starting to receive the attention that it deserves. As a result, doctors and patients are now coming to terms with the serious health issues associated with sleep apnea and the universe of people affected by this condition," said Rochelle Goldberg, MD, president of the American Sleep Apnea Association. "It's wonderful to see that time and resources are being applied to bring innovative sleep apnea treatments to patients who are searching for alternate ways to treat this condition."

The Pillar Procedure is designed as a first-line treatment option for palate-related mild-to-moderate sleep apnea and can be used in combination with other treatment options. It was developed based on a scientific, research-oriented approach, combined with an in-depth understanding of physiology and anatomy.

The Pillar Procedure has achieved comparable results to those of more aggressive surgical procedures like UPPP UPPP uvulopalatopharyngoplasty.

UPPP
abbr.
uvulopalatopharyngoplasty


Uvulopalatopharyngoplasty (UPPP) 
 and LAUP LAUP Laser-assisted uvulopalatoplasty A surgical alternative to UPPP–uvulopalatopharyngoplasty for treating obstructive sleep apnea and other sleep disorders, in which throat and palate tissues are removed to open the airway. See Sleep apnea. , with very low complications. Most patients soon report a noticeable reduction in snoring. In nearly 80 percent of patients in an obstructive sleep apnea clinical study, sleep apnea was reduced. More than 80 percent of these clinical trial patients and their partners would recommend the Pillar Procedure. Using a combination of sleep testing and physical exams, physicians can determine which options are appropriate for individual patients.

"When I was diagnosed with mild sleep apnea, the doctor explained that there were essentially two treatment options, wearing a CPAP machine for the rest of my life or surgery. I didn't think either option was the one I wanted to have to choose," says Phyllis Gernhardt. "Then I heard about the Pillar Procedure. I was in and out of the doctor's office in no time, had very little pain, and more important than any of this, I was actually able to get a good night's sleep and recently experienced my first dream in years."

Restore Medical will be demonstrating the Pillar Procedure at the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF AAO-HNSF American Academy of Otolaryngology-Head and Neck Surgery Foundation ) annual meeting taking place at the Jacob K. Javits Convention Center Jacob K. Javits Convention Center is a large convention center on the west side of Manhattan in New York City. It was designed by architects I. M. Pei and partners. The revolutionary space frame structure was built in 1986 and named for New York Senator Jacob K.  in New York City New York City: see New York, city.
New York City

City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S.
 on September 19-22, 2004 at booth number 1400. A series of presentations will also be conducted. (See press release, "New Research on Restore Medical Pillar Procedure to be Presented at American Academy of Otolaryngology-Head and Neck Annual Meeting.")

To learn more about Restore Medical and the Pillar Procedure, or to find an ear, nose and throat physician (ENT ENT ears, nose, and throat (otorhinolaryngology).

ENT
abbr.
ear, nose, and throat



ENT

ear, nose and throat.

ENT Ears, nose & throat; formally, otorhinolaryngology
) in your area, visit www.restoremedical.com.

To learn more about sleep apnea, visit the web site of the American Sleep Apnea Association at www.sleepapnea.org.

About Restore Medical

Restore Medical, a privately held company privately held company

A firm whose shares are held within a relatively small circle of owners and are not traded publicly.
 based in St. Paul, Minn., develops and markets innovative devices designed to treat upper airway disorders, such as sleep apnea and snoring. Restore Medical manufactures the Pillar system in its on-site, state-of-the-art Class 100,000 Clean Room. The company is ISO (1) See ISO speed.

(2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI.
 9001 certified and utilizes an intranet based quality and product development system. For more information about the Pillar system and physicians who offer the treatment, visit the company's Web site at www.restoremedical.com.

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Date:Sep 14, 2004
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