A new player in the fast-emerging field of neurostimulation has completed development and is about to start human trials of its Targeted Hypoglossal Neurostimulation (THN) system for obstructive sleep apnea (OSA), a condition which causes snoring but, more importantly, can lead to health complications ranging from heart disease to stroke.
ImThera Medical's (San Diego) system provides a surgical option for patients who cannot or will not comply with continuous positive airway pressure (CPAP), the established therapy for OSA. It's estimated that half of the 800,000 patients diagnosed with OSA in the U.S. don't use CPAP, which requires the user to sleep with a face mask that delivers airflow.
"There are two types of apnea and obstructive affects 95% of these patients. The reasons are not fully understood, but we know the tongue just loses muscle tone like our limbs relax when we sleep," Marcelo Lima, chairman/president/CEO of ImThera told Medical Device Daily. "Our target population is the non-compliant CPAP patient, which is 50% of the people who have OSA and it's costing the U.S. economy $20 billion to $25 billion a year because of the complications of OSA. We hope to become the therapy of choice, although I think people should try CPAP first."
The new product, called the aura6000, will be unveiled Monday at the American Academy of Otolaryngology-Head and Neck Surgery (Alexandria, Virginia) annual meeting in San Diego.
Neurostimulation is a trendy approach these days to treat a variety of conditions because it offers a new level of efficacy coupled with low rates of complications and side effects compared with drugs and surgery to treat the same ailments. In fact, neurostimulation as a sector has been growing at an average rate of 16% per year since 2007 and a study by Scientia Advisors (Cambridge, Massachusetts) projects growth rates of 14% to 23% for certain technologies through 2012. This melding of neurobiology and a medical device is typically reversible too (MDD, August 21, 2009).
ImThera's aura6000 delivers neurostimulation to the hypoglossal nerve to control certain muscles of the tongue. Using a multi-contact electrode and a programmable implantable pulse generator, the system delivers muscle tone to key tongue muscles to prevent the tongue from collapsing into the upper airway.
External components include a patient's controller/charger and a physician's notebook PC which includes the aura6000 Clinical Manager THN Sleep Therapy physician software. Targeting multiple tongue muscles to deliver therapy; it operates in open loop, continuous mode during sleep.
The system, invented by ImThera Medical just three years ago, is designed to increase airway flow, permitting normal and restful sleep for OSA patients. Animal trials were conducted in 2008 and now prototypes are ready for a 12-patient clinical trial scheduled to begin within a month in Europe. ImThera has received Ethics Committee clearance to begin human clinical trials in Belgium and has received ISO 13485 certification of its quality system as a prerequisite for the future CE mark application for European commercialization of medical products. Results from this pilot study are set to be published during 1Q10.
"The surgery takes approximately 25 to 45 minutes," Lima said. "The surgeon places an electrode that self wraps around hypoglossal nerve at base of neck with an incision that's 3 cm to 5 cm. A 3 cm to 4 cm incision is also made in the chest and the surgeon guides a canula up the chest, under skin to the base of the neck to drop the lead wire and connects it to IPG and places over pectoral muscle. It's one of the smallest IPGs in the world at 11.5 cubic cm in volume."
The IPG he refers to is a multi-contact electrode and a programmable implantable pulse generator (IPG). About a week after the device is implanted, a pulmonary physician or sleep lab technician will turn on the device and program it to deliver tongue muscle tone that opens up the airway. During the trial, investigators will validate efficacy with nasal endoscopy while the patient is awake along with a follow-up in a sleep lab to evaluate how it's working.
"The patient experience is much like any other neurostimulation device ... a tiny tingling sensation," he said, adding that a couple of patients were already implanted with the device outside of the U.S. as part of engineering experiments. "So we know it works."
The trial in Europe, at the Catholic University of Louvain (Belgium), will gather safety and efficacy data and set the stage for submission to the FDA in the U.S., which Lima said will be occur during the first half of 2010.
Lima said ImThera Medical, a private company, is sufficiently funded with a $5 million investment that will take the company through 2010. With no partners, the new firm plans to produce its own devices, build a sales force in the U.S. and look for dealers and distributors in Europe.
"Our mission is to help moderate-to-severe OSA patients enjoy better lives while substantially reducing healthcare costs related to serious complications associated with OSA," Lima said.
In addition to heart disease and stroke, other potential complications of OSA include abnormal heart rhythm, excessive carbon dioxide levels in the blood, high blood pressure and sleep deprivation. A person with OSA basically stops breathing (apnea) for periods throughout the night. Resulting symptoms can include: abnormal daytime sleepiness, awakening unrefreshed, depression, lethargy, memory difficulties, morning headaches, personality changes, poor concentration and overall restless sleep which is riff with loud snoring.
Lynn Yoffee, 770-361-4789;