Apnex Medical, Inc., has received CE Mark approval for its Hypoglossal Nerve Stimulation (HGNS®) System for use by people who suffer from obstructive sleep apnea (OSA). The system was approved for sale in Europe based on the positive results of two clinical studies conducted in the United States and Australia. In those studies, the majority of patients demonstrated a significant reduction in their obstructive sleep apnea as well as substantial improvements in the quality of their sleep, quality of life, and overall health.
“CE Mark approval is an important confirmation of the substantial benefits that patients receive from our HGNS therapy for obstructive sleep apnea and is a key milestone for our company,“ said Chas McKhann, Apnex Medical President and CEO. “We are excited to bring this innovative new therapy to Europe. We are also 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 of the tongue, to 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.
Many patients who suffer from OSA are unable to tolerate existing therapies such as CPAP. The HGNS System provides a fundamentally new approach to the treatment of OSA. This study will help us further understand the potential role this device will have in treating the millions of people who suffer from OSA.
Source: Apnex Medical Inc