Healthcare Industry News: obstructive sleep apnea
News Release - September 18, 2007
New U.S. Multi-Center Clinical Study Affirms Efficacy and Benefit of Restore Medical's Pillar(R) ProcedureResults of Double-blind, Placebo-controlled OSA Clinical Study Reported at the 111th AAO-HNS Annual Meeting
ST. PAUL, Minn.--(HSMN NewsFeed)--Restore Medical, Inc. (NASDAQ:REST ), developer of the innovative Pillar® Palatal Implant System - a simple, minimally-invasive treatment to help individuals suffering from snoring and mild-to-moderate obstructive sleep apnea (OSA) - today announced the presentation of positive results from the first U.S. multi-center Level 1 evidence based medicine clinical study of its Pillar palatal implants, which affirmed the efficacy observed in earlier studies in the treatment of mild to moderate OSA. David Steward, M.D., Associate Professor and Director of Clinical Studies, University of Cincinnati Medical Center, and his colleagues, presented their findings, "Palate Implants for OSA: Multi-Institution, Randomized, Placebo Controlled Study," yesterday at the 111th Annual Meeting & OTO EXPO of the American Academy of Otolaryngology - Head and Neck Surgery Foundation in Washington D.C.
One hundred adults with mild to moderate OSA were enrolled in this clinical study and randomized into two groups. Patients in the treatment group underwent a procedure in which they received three Pillar palatal implants, and patients in the control group underwent an identical procedure, but did not receive Pillar palatal implants. The investigators evaluated and compared objective and subjective outcomes of patients in both groups, and reported statistically significant differences in the primary and several secondary outcome measures favoring the group receiving Pillar palatal implants as compared to the placebo control group.
Bob Paulson, President and CEO of Restore Medical, stated, "The reported outcomes from this U.S. multi-center Level 1 clinical study are consistent with the U.S. single center Level 1 placebo-controlled clinical data reported by Dr. Michael Friedman at the 2006 AAO annual meeting. Pillar palatal implants add structural support to and stiffen the soft palate, eliminating or minimizing the soft palate flutter or collapse that can cause or contribute to chronic snoring and OSA. While people with OSA generally suffer from obstruction of more than one level of the upper airway, the soft palate is a contributing factor in approximately 80 percent of cases, and Pillar palatal implants can effectively treat the soft palate alone, or as part of a combination procedure to treat multi-level upper airway obstruction. The findings from these clinical studies demonstrate that the Pillar Procedure is a simple, office-based procedure with minimal pain or complications, which can effectively treat the soft palate component of mild to moderate OSA and significantly improve patients' quality of life."
About Restore Medical
Restore Medical develops, manufactures and markets innovative medical devices to treat sleep-disordered breathing. The Company's proprietary Pillar Palatal Implant System is the only implantable palatal device to treat snoring and mild-to-moderate obstructive sleep apnea to be approved by the U.S. Food and Drug Administration and Health Canada, and to have received the CE Mark for sale in the European Union. The Pillar Palatal Implant System is sold throughout the U.S. and Canada, and in various countries in Asia Pacific, Europe, South America and the Middle East.
For more information about Restore Medical, the Pillar Procedure and physicians who offer the Pillar Procedure, visit the Company's website at www.restoremedical.com or www.pillarprocedure.com.
Except for historical information, this press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements included in this press release that address activities, events or developments that Restore Medical expects, believes or anticipates will or may occur in the future, including, particularly, statements about actual or anticipated outcomes of clinical studies, are forward-looking statements. All forward-looking statements are based on assumptions made by Restore Medical's management based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the Company's control, and which could cause actual results or events to differ materially from those expressed in such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, market demand and acceptance of the Company's products, competitive factors, pricing and third-party reimbursement for the Company's products, expansion and rate of success of the Company's sales force, completion and results of clinical studies, ongoing regulatory compliance, success of new product development, general economic conditions and seasonal trends, and other risks and factors that are discussed in documents filed by Restore Medical with the Securities and Exchange Commission from time to time, including its Annual Report on Form 10-K for the year ended December 31, 2006. Forward-looking statements represent the judgment of the Company's management as of the date of this release, and Restore Medical disclaims any intent or obligation to update any forward-looking statements.
Source: Restore Medical
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