ST. PAUL, Minn., March 8, 2012 /PRNewswire/ -- Three articles have recently been published showing positive results from the Apnex Hypoglossal Nerve Stimulation (HGNS®) System clinical studies in the United States and Australia.
The most recent article by Dr. George Goding et al. was published online in February 2012 in the Otolaryngology Head Neck Surgery journal.(1) This study examined the acute effects of HGNS therapy using fluoroscopic imaging, and it showed that the HGNS System opened patients' airways not only at the base of the tongue, but throughout the airway in patients with obstructive sleep apnea (OSA). "Using fluoroscopy, we can clearly see that HGNS therapy has a positive effect in multiple parts of the airway in the majority of patients," said Dr. Goding, an Associate Professor of Otolaryngology at the University of Minnesota. "These findings are important because they indicate that the HGNS therapy has the potential to treat a broad range of patients with OSA, not just those with isolated tongue-based prolapse."
A second article was recently published online by Dr. Alan Schwartz et al. and became available in print in February of this year in the American Journal of Respiratory and Critical Care Medicine.(2) It showed the HGNS System increased airflow in all subjects without arousing patients from sleep. It also demonstrated that increases in airflow from the HGNS System provided substantial relief of upper airway obstruction during sleep in patients with a wide range of OSA disease severity.
A third article was published in Sleep by Dr. Peter Eastwood et al. in November 2011 on the 6-month results of the Australian feasibility study.(3) The HGNS System was found to have a favorable safety and efficacy profile. Patients had significant decreases in their OSA severity and reductions in their OSA-associated symptoms.
"At Apnex Medical, we are committed to building a strong body of clinical evidence to support the use of our HGNS system in appropriate patients with OSA. We are very pleased that the results from the Apnex feasibility trials have now resulted in three peer-reviewed publications in leading medical journals. These recent findings demonstrate how the HGNS System works and that the therapy can be effective in treating moderate-to-severe OSA," said Chas McKhann, Apnex Medical President and CEO. "We are focusing on further evaluation of the HGNS System in the Apnex® Clinical Study, a randomized clinical trial of the HGNS System that is enrolling patients in the United States, Australia and in select countries in Europe."
About Apnex Medical, Inc. and the HGNS System
Apnex Medical was founded in 2006 with a mission to pioneer medical innovations to improve the health of people with sleep disordered breathing. The company has developed a proprietary medical device for the treatment of OSA.
The Apnex HGNS System is an implantable therapy that is intended to work by activating the muscles in the upper airway to ensure that the airway remains open during sleep. During sleep, the system detects the patient's breathing and delivers mild stimulation to the hypoglossal nerve, the nerve that controls the muscles that keep the airway open. The stimulation is timed to a patient's own breathing pattern. The HGNS System is programmed to work only when the patient is asleep, or it can be turned on and off as needed through a handheld controller.
According to the World Health Organization approximately 100 million people worldwide have OSA. It occurs because the airway muscles fail to keep the airway open during sleep, despite efforts to breathe. This deprives OSA sufferers of deep restful sleep. In addition to excessive daytime drowsiness and fatigue, OSA sufferers are at an increased risk for a variety of health conditions, including high blood pressure, coronary artery disease, diabetes and stroke. Untreated OSA is also associated with an increased risk of death. Current OSA treatments are not always successful or well tolerated. The Apnex device is designed to provide an alternative treatment for OSA that addresses these problems.
About Apnex Clinical Study
Apnex Medical, Inc., received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to conduct a clinical study to evaluate the safety and effectiveness of its HGNS System in people who suffer OSA. Data from this clinical study is intended to support the Pre-Market Approval (PMA) application for the HGNS System to the FDA.
The Apnex Clinical Study is a prospective, randomized, multi-center clinical trial. It is being conducted in leading medical centers in the United States, Europe and Australia. The trial is designed to demonstrate the safety and effectiveness of the HGNS therapy in treating patients with moderate or severe OSA who have not received lasting benefit from continuous positive airway pressure (CPAP) and other OSA treatments.
For more information on the Apnex Clinical Study, including participation requirements, visit www.SleepApneaTrial.com or call 1-888-975-3370.
For access to the abstracts of the three publications described in this news release go to PubMed at:
1. Goding GS Jr, Tesfayesus W, Kezirian EJ. Hypoglossal Nerve Stimulation and Airway Changes under Fluoroscopy. Otolaryngol Head Neck Surg. 2012 Feb 3.
2. Schwartz AR, Barnes M, Hillman D, Malhotra A, Kezirian E, Smith PL, Hoegh T, Parrish D, Eastwood PR. Acute Upper Airway Responses to Hypoglossal Nerve Stimulation during Sleep in Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2012;185(4):420-426.
3. Eastwood PR, Barnes M, Walsh JH, Maddison KJ, Hee G, Schwartz AR, Smith PL, Malhotra A, McEvoy RD, Wheatley JR, O'Donoghue FJ, Rochford PD, Churchward T, Campbell MC, Palme CE, Robinson S, Goding GS, Eckert DJ, Jordan AS, Catcheside PG, Tyler L, Antic NA, Worsnop CJ, Kezirian EJ, Hillman DR. Treating obstructive sleep apnea with hypoglossal nerve stimulation. Sleep. 2011;34(11):1479-1486.
CAUTION: The Apnex HGNS System is an investigational device and is limited by Federal Law to investigational use.
FOR CLINICAL TRIAL USE ONLY.
Apnex Medical, Apnex and HGNS are registered trademarks of Apnex Medical, Inc.
© Apnex Medical, Inc. 2012 All rights reserved.
SOURCE Apnex Medical, Inc.