2013-02-27 19:02:29 -
Authors Reach Conclusions After a
Meta-Analysis of 7 Clinical Studies for Snoring, and 7 Studies for OSA
MINNEAPOLIS - Feb. 27, 2013 - In a meta-analysis of seven studies published in
the January issue of Laryngoscope, Ji Ho Choi, M.D., Ph. D., and coauthors
conclude that the Medtronic Pillar Procedure significantly reduced snoring
loudness and mild-to-moderate obstructive sleep apnea (OSA).
The Medtronic Pillar Procedure was cleared by the Food and Drug Administration
(FDA) as a treatment for snoring in 2002 and for mild-to-moderate OSA in 2004.
A minimally invasive, tissue-sparing procedure, doctors perform the Pillar
Procedure as an alternative to more invasive surgical procedures to remove
obstructive tissues in the upper airway that contribute to snoring and OSA.
Choi and his colleagues write, "Various surgical procedures
on the upper airway
have been attempted for snoring and OSA. Yet their effect remains equivocal.
This is mainly because of a shortage of evidence on the surgical results and the
absence of definitive criteria about surgical success."
For their analysis of the effect of the Pillar Procedure on snoring, Choi and
his colleagues used seven case-controlled studies, with a total enrollment of
174 subjects. These studies all used the post-procedure Visual Analogue Scale
(VAS) score compared to the pre-procedure score as their primary outcome
measure. VAS is a measure of snoring intensity. The meta-analysis results
indicate that the Pillar implant reduced snoring sound significantly as compared
to preprocedure values with a standardized mean difference of -0.591 (p<0.001).
Study authors also analyzed the efficacy of the Pillar procedure as a single
surgical procedure for the treatment of mild to moderate OSA. The seven
selected studies included five case series and two placebo-controlled trials.
The total number of subjects enrolled in the seven studies was 363, of which 76
were in placebo control groups.
The primary OSA outcome measures for the seven selected studies included the
Epworth Sleepiness Scale (ESS), and the Apnea-Hypopnea Index (AHI).
The ESS is a questionnaire completed by each person who self-identifies his or
her likelihood of falling asleep during the day in eight different situations.
AHI is a measure of the mean number of times a person experiences an episode of
apnea or hypopnea (partial or complete blockage of the airway) during an hour of
sleep. The results of the meta-analysis indicate that the Pillar implant
significantly reduced ESS as compared to preprocedure values with a standardized
mean difference of -0.481 (p<0.001), and significantly reduced AHI as compared
to preprocedure values with a standardized mean difference of -0.378 (p=0.002).
The authors' study, "Efficacy of the Pillar Implant in the Treatment of Snoring
and Mild-to-Moderate Obstructive Sleep Apnea: a Meta-Analysis," can also be read
online at www.laryngoscope.com.
About The Medtronic Pillar Procedure
The Pillar(®) Procedure is a method for stiffening the soft palate to address
tissue vibration and collapse that can block the upper airway and contribute to
snoring and mild to moderate OSA. A specially trained surgeon places small
implants into the soft palate. Over time, the implants work with the body's
natural fibrotic response to add structural support (stiffen) the soft palate.
This structural support helps to reduce the tissue vibration that can cause
snoring. In July 2012, the FDA cleared new labeling information for the Pillar
Palatal Implant system that allows surgeons to use up to five Pillar Implants
specifically for snoring. For more information, visit www.PillarProcedure.com
About Medtronic Surgical Technologies
The Surgical Technologies business develops products and procedural solutions
for surgical applications that include: neuro spine, cranial and orthopedics;
ear, nose and throat; and surgical oncology. Surgical Technologies designs,
develops, manufactures and supports healthcare providers with advanced surgical
navigation and imaging solutions, powered surgical tools and systems,
intraoperative nerve monitoring devices, advanced energy-based devices for
hemostatic sealing and tissue dissection, and implantable devices for
Medtronic, Inc. (NYSE: MDT) (www.medtronic.com), headquartered in Minneapolis,
is the global leader in medical technology - alleviating pain, restoring health,
and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from anticipated
- end -
Natalie St. Denis
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Source: Medtronic, Inc. via Thomson Reuters ONE