PLZEN, Czech Republic, October 7 /PRNewswire/ --
LENTE Clinic announced today that it had successfully treated its first patients with the third-generation Advance System implant for obstructive sleep apnea.
Dr.Václav Pavelec MD, the site principal investigator, commented, "The Advance System is unique in that it addresses a part of the airway -- the base of tongue -- that is currently not easily treatable with surgical procedures. The Advance System was very simple to implant, and only required a short time to complete. The patients who have received the Advance find it quite tolerable, which is revolutionary in sleep apnea surgery. We are looking forward to continuing this study of this groundbreaking device and important alternative to other treatments for obstructive sleep apnea."
The Advance Study evaluates the feasibility, safety and efficacy of the Advance System. The effect of the Advance System is evaluated by both objective and subjective measures including polysomnography (PSG), and patient questionnaires.
LENTE Clinic is expecting to enroll up to 15 additional patients in this study. All costs of the study are covered by the study sponsor. Requirements to be considered for the study include previously diagnosed obstructive sleep apnea with an apnea-hypopnea index (AHI) of between 15 and 50, and inability to continue using CPAP (continuous positive airway pressure), and airway obstruction primarily at the base of tongue.
Obstructive Sleep Apnea
Obstructive sleep apnea (OSA) is a major heath problem in the Czech Republic. Nearly 5% of the adult population of the Czech Republic have moderate to severe OSA, which is characterized by frequent awakening during sleep, heavy snoring and daytime sleepiness. If left untreated, OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure. Despite its prevalence and increased recognition as a cardiovascular risk factor, OSA remains largely under diagnosed.
The first line and most common treatment for OSA is continuous positive airway pressure (CPAP) treatment. However, CPAP is difficult for patients to use. Patients who fail CPAP therapy are often referred to surgical therapy.
The Advance(TM) System
The Advance System is used in a minimally invasive surgical procedure where the tongue is suspended forward with the intent of preventing collapse of the airway during sleep. The procedure is performed by ear nose throat (ENT) specialists/otolaryngologists and includes a device that is surgically implanted in the tongue and lower jaw. Once implanted, adjustments can be made to the Advance System at the time of the procedure or later to further advance the tongue in order to maintain an open airway during sleep.
About LENTE Clinic Plzen
The LENTE Clinic in Plzen is a specialized group of clinicians committed to high quality patient care with leading edge approaches to sleep disordered breathing, including snoring and sleep apnea. The Clinic has a research focus on the treatment of sleep apnea and its clinicians have been involved in a number of protocols involving devices for the treatment of obstructive sleep apnea.
About Aspire Medical
Aspire Medical, the manufacturer of the Advance System and study sponsor, is a US-based company, founded in 2004 and is a medical device company focused on developing minimally invasive treatments for obstructive sleep apnea (OSA).
For more information about Aspire Medical, please visit its website at http://www.aspiremedical.com.
Web site: http://www.aspiremedical.com
Dr. Václav Pavelec of LENTE Clinic, +420-604-243-945 pavelec@lente.cz; or Aspire Medical, Inc., +1-408-481-1100, ext. 102, info@aspiremedical.com
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