Source: Restore Medical Incorporated
Tuesday, January 28, 2003
Patented Implant System Offers One-Time Minimally Invasive Procedure For
Snorers
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Restore Medical Incorporated
(formerly Pi Medical, Inc.) has received 510(k) marketing clearance from the
U.S. Food and Drug Administration for its Pillar(TM) Palatal Implant System.
This breakthrough minimally invasive treatment is designed to permanently
treat socially disruptive snoring, a serious health and lifestyle problem
afflicting more than 27 million Americans and their bed partners. The company
is planning a general commercial release of the Pillar system in the second
quarter of 2003, initially focusing on otolaryngologists (ear, nose and throat
physicians) who treat snoring patients.
"For the first time, patients and their physicians have a minimally
invasive snoring treatment option that is designed to produce lasting results
after a single, brief, virtually painless procedure," said Restore Medical
President and Chief Executive Officer, Susan L. Critzer. "Our clinical
studies have shown that when our Pillar implants are placed in the patient's
soft palate, they alter the palate's dynamic response to airflow and
substantially reduce the severity of snoring in many individuals."
The highly engineered, cord-like Pillar device is less than one inch long.
It is woven from a polyester material that has been used for many years in
implantable medical products. The implant procedure is conducted in a
physician's office using local anesthesia. In clinical trials of more than
100 patients, the entire procedure lasted an average of less than 10 minutes.
Most patients reported that the procedure was virtually painless and that they
were able to resume normal activities and diet the same evening. Unlike
previous treatments, the Pillar implant stiffens the soft palate without
heating or removing tissue.
Most existing snoring therapies have involved stiffening the palate by
scarring and removing tissue. In 2002, an estimated 140,000 such procedures
were performed in the United States. These therapies can be effective for
some patients, but many have to undergo multiple procedures to maintain any
benefit and others see no sustainable benefit at all. The inconsistency in
results can be attributed to a variety of factors, including the
unpredictability of scarring responses among patients and the body's natural
tendency to remodel scars over time.
"Because of these drawbacks, only about one-third of patients who see a
physician about snoring treatment currently elect to have surgery," said
Critzer. "Physicians and their patients need a better solution. With our
strong clinical results and a one-time procedure with minimal discomfort, we
are offering that solution."
Restore Medical believes that its patented implant technology may also be
applied in the future to the treatment of Obstructive Sleep Apnea (OSA), a
condition that repeatedly disrupts sleep. The company is conducting research
in this area. In addition, Restore Medical has begun research efforts for the
treatment of other upper airway disorders.
About Restore Medical
Restore Medical is a privately held company based in St. Paul, Minn., that
develops and markets innovative devices designed to treat upper airway
disorders, such as snoring and sleep apnea. 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. Restore currently employs a team of approximately
35 professionals, including a dedicated sales team.