The End of CPAP?

What do yo guys think?
ImThera Medical Successfully Implants First Patients with Neurostimulation Device to Treat OSA

SAN DIEGO--(BUSINESS WIRE)--ImThera Medical, Inc. today announced that two patients have been surgically implanted with ImThera’s aura6000™ neurostimulation device for treating tongue-based Obstructive Sleep Apnea (OSA). Patients are being enrolled in ImThera’s pilot clinical investigation in Belgium with the first results expected to be published in the first half of 2010.

The patients were implanted with the aura6000, during which the hypoglossal nerve was briefly stimulated to verify system and nerve integrity. One week post- surgery, the patients underwent an in-laboratory Polysomnography (PSG) titration process during which stimulation parameters were determined in order to maintain proper tongue position and to provide an open airway during sleep.

“The surgical procedures went smoothly, taking approximately 90 minutes to complete. There were no surgical complications; minor surgical issues were quickly resolved. At one week, patients were not disturbed by the implanted stimulator, lead or electrode,” said Dr. Philippe Rombaux, Head of Otolaryngology Surgery at the Université Catholique de Louvain, Belgium.

“Speech, swallowing and tongue sensibility were not disturbed by surgery. Stimulation resulted in effective and painless tongue movement during wakefulness. During sleep, stimulation at sufficient levels was not perceived by the patients and did not interrupt sleep. Although this was not at all an outcome planned for the analysis at one week after surgery, sleep apnea severity was improved during electrical stimulation. Clinical benefit can only be appreciated in the future, therefore we are looking forward to the results of this pilot study,” said Professor Dr. Daniel Rodenstein of the Université Catholique de Louvain, Belgium; and principal investigator of the European study.

The physicians observed substantial improvement in upper airway opening and flow measured by normal sleep and a reduced AHI during the post surgery PSG.

Dr. Terence Davidson, ImThera’s Chief Medical Officer, was impressed with the ease of the surgery and the performance of the aura6000 components. “It is rare that an initial clinical trial proceeds so well and with such an impressive start.”

More than 800,000 patients in the U.S. are diagnosed with OSA annually. While Continuous Positive Airway Pressure (CPAP) is the established therapy, studies show that only 54 percent of patients comply with CPAP. The aura6000 is based on ImThera’s Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy™, delivering neurostimulation to the tongue during sleep.

“ImThera’s mission is to provide a safe and effective alternative for OSA patients that will not or cannot comply with CPAP,” said Marcelo G. Lima, Chairman, President and CEO of ImThera Medical. “With a simple implant procedure, patients are expected to sleep better, without obstructive apnea events, which will ultimately help them achieve a better quality of life, while reducing the effects of the many serious comorbid consequences of OSA. We are very pleased with the first successful implantations and we look forward to the early results from these trials.”

CAUTION: The aura6000 is not for sale in the U.S.A.

About ImThera Medical, Inc (http://www.imtheramedical.com)

Based in San Diego, ImThera Medical is a privately funded, early-stage company developing a patent-pending, neurostimulation medical device for the treatment of Obstructive Sleep Apnea (OSA).

ImThera’s Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy delivers neurostimulation to the hypoglossal nerve to control certain muscles of the tongue. Using a multi-contact electrode and a programmable implantable pulse generator (IPG), the system delivers muscle tone to key tongue muscles to prevent the tongue from collapsing into the upper airway during sleep. This innovative technology is designed to increase airway flow, permitting normal and restful sleep for OSA patients.

Thanks for the updated news, Mac.

For background, here's a topic rooster started:
viewtopic.php?p=343232#p343232

Hi All

Thanks for reminding me of this possibility.

When I go travelling I like complete freedom to go anywhere and be anywhere. This has often meant that I sleep out. Also I did most of my travelling in the US and Canada by Greyhound , often travelling overnight. That is now no longer possible.

Having to use a cpap machine has totally ruined my way of travelling, so I welcome this news, and look forward to it really working before I die. That is, if the vested cpap interests don't divert it into obscurity.

I really hope it works.

cheers

Mars

I heard it fixes that embarrassing snort when you laugh too!


Worked for Homer!

Mars,
CPAP is really something from the Stone Age. I was shocked what the treatment was to the point where I wish I never got tested. There are two other companies racing to get similar devices to market so I doubt the CPAP makers will squash this What will happen they will buy one of these companies.

Any independent figures on how many OSA patients have "tongue-based" OSA, and then what percentage of those would just have another part of their airway collapse after the tonque was pulsed out of the way?

Seems to me this would only help the same people who would be cured with positional therapy, to keep the tongue out of the throat, if all it treats is the tongue--or are they eventually gonna wire up the entire airway?

Then again, it is my job is to be critical and negative.

Quick Facts

* Obstructive Sleep Apnea (OSA) is a debilitating, often life-threatening sleep disorder.
* OSA is extremely common: 24% of adult men and 9% of adult women.
* Prevalence is similar to diabetes or asthma.
* Mild OSA becomes more severe with time.
Mild: AHI 5–15
Moderate: AHI 15–30
Severe: AHI >30
AHI = Apnea Hypopnea Index, number of such events per hour of sleep
* An estimated 38 million Americans have OSA, with 15 million moderate to severe OSA.
* Approximately 20% are being treated.
* 800K+ patients being diagnosed per year in the USA.
* Loss of tongue muscle tone during sleep causes the obstruction in 85% of patients with OSA.
* Continuous Positive Airway Pressure (CPAP) device is the established therapy.
* Approximately 3 million patients have CPAP machines in North America.
* Studies have shown that more than 46% do not comply with CPAP.

"Although the velopharynx was the most common site of obstruction (in 89% of patients), most patients (72%) had multiple sites of obstruction. . . . These data are in agreement with modeling the upper airway as a Starling resistor. In physiology, the Starling resistor model of collapsible tubes suggests that collapse can occur in various different portions of the collapsible segment, making a targeted approach based on a single observation of narrowing unlikely to be successful."-- Curr Opin Pulm Med. 2008;14(6):519-524. © 2008 Lippincott Williams & Wilkins
http://www.medscape.com/viewarticle/584505_2

The upper airway begins at the entrance of the nose and continues to the hypopharynx. Each part of this tract can cause obstruction, and sometimes, obstruction is found in several areas in varying degrees. The structures forming the upper airway are the nose and the pharynx with its 3 divisions (ie, nasopharynx, oropharynx, hypopharynx). Each of these areas has different pathologies . . . The velum of the palate is particularly important for the pathology of airway obstruction. A long velum or a flaccid velum can produce obstruction. The soft palate frequently is elongated, increasing the possibility of snoring. Many patients have pharyngeal and palatal edema after sleep because of the snoring-induced trauma. . . . The uvula generally is larger than that of the normal population. This is due to edema and thickening of the covering epithelium. . . . . . . Perhaps the most important factor in OSA is the collapsibility of the pharynx. Most persons with OSA have a decreased tone of the pharyngeal muscles. This allows the pharynx to collapse even with small levels of intrapharyngeal negative pressure (see Müller maneuver). . . . . . . Superior airway resistance measurement and manometry were developed to evaluate the difference in pressure in the areas with high possibility of collapse (ie, hypopharynx, oropharynx, the region of the velum of the palate). The relative pressures in these areas are compared with the pleural pressure measured through the esophagus. This test may be performed during polysomnography; however, this test is not commonly used because of its complexity.-- Snoring and Obstructive Sleep Apnea, Upper Airway Evaluation, David Núñez-Fernández, MD, PhD, Updated: Jun 16, 2008 http://emedicine.medscape.com/article/868925-overview

I guess this would be kind of like Viagara for the togue ha?

On a lighter note, I don't think I could sleep restfully without my mask and machine on. I have become so comfortable with it on that I don't sleep well without it and I don't just mean adding the OSA back in.

For one the filter on the machine cleans the air better than just a room filter. I wake up with my sinuses cleared than before I went to sleep.

Gerry