PROVENT(R) Therapy Shown to be Clinically Effective in Treating Mild, Moderate and Severe Sleep Apnea
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SAN ANTONIO, June 8, 2010 (GLOBE NEWSWIRE) -- Ventus Medical, a privately held medical device company focused on improving the lives of patients with obstructive sleep apnea (OSA), today announced additional data further confirming the clinical efficacy of its PROVENT® Sleep Apnea Therapy device. Results from two clinical trials were presented during the SLEEP 2010 24th Annual Meeting of the Associated Professional Sleep Societies (APSS), being held June 5-9 in San Antonio, Texas.
James K. Walsh, PhD, Executive Director of the Sleep Medicine and Research Center at St. Luke's Hospital in St. Louis, Missouri reported that patients using PROVENT Therapy had clinically meaningful and statistically significant decreases in the apnea-hypopnea index (AHI) – a measure of breathing disruptions during sleep. PROVENT Therapy was accepted by 80% of patients who had previously refused continuous positive airway pressure (CPAP) therapy or used CPAP fewer than three hours per night on average. The study also found that PROVENT Therapy use improved blood oxygen saturation, and resulted in less daytime sleepiness as measured by the Epworth Sleepiness Scale. "Current treatment options for obstructive sleep apnea are suboptimal. When used properly, CPAP essentially eliminates sleep apnea, but a large percentage of patients are non-compliant and express significant dissatisfaction with CPAP," stated Dr. Walsh. "These data provide evidence that PROVENT is a treatment option for many patients who were unable to tolerate or unwilling to try CPAP therapy."
Richard Berry, MD, from the University of Florida, reported results from a multi-center, randomized, controlled trial of PROVENT versus a placebo (or sham) device. This study also showed that PROVENT Therapy significantly reduced AHI, improved oxygen saturation in the blood as well as reduced daytime sleepiness when compared to the sham device. "Many OSA patients are inadequately treated due to adherence or efficacy issues with current therapy. Alternative effective treatments for OSA are needed," said Dr. Berry. "The results of the study suggest that PROVENT Therapy is an effective treatment alternative for a substantial percentage of OSA patients."
About PROVENT Sleep Apnea Therapy
PROVENT Therapy is indicated for the treatment of OSA. It is a simple, noninvasive prescription treatment that works across mild, moderate, and severe OSA. The treatment utilizes nasal expiratory positive airway pressure (EPAP) and has been clinically shown to treat sleep apnea. The device incorporates a valve design that is placed over the nostrils and secured with hypoallergenic adhesive. During inhalation, the valve opens allowing nearly unobstructed airflow, and during exhalation, the valve closes, directing airflow through two small openings, which increases expiratory airway pressure. PROVENT Therapy is commercially available in the United States.
About Ventus Medical
Ventus Medical is a privately held medical device company focused on transforming the treatment of sleep disordered breathing. Located in Belmont, California, Ventus Medical has developed and markets PROVENT, a new breakthrough therapy for OSA. Existing OSA solutions do not always meet patients' needs. Through truly innovative technology, solid clinical evidence, and a focus on the patient, Ventus Medical seeks to deliver consumer-preferred, physician-recommended solutions.
CONTACT: Lazar Partners
Media Contact:
Erich Sandoval
917-497-2867
esandoval@lazarpartners.com
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