February 27, 2009: Implantable Device Replaces CPAP

rested gal wrote:Your nickname... are you a vet?

mdpooch wrote:LOL.....no even thought a lot of people have asked the same question

rested gal wrote: ....... I've probably asked you before, myself.... and forgot I asked you.
and.....
I'll probably ask you again in a year or so, having forgotten that I asked you in September 2009.

mdpooch wrote:I have recently haved moved my mother from Montana back to Wyomin , She has done extremely well with the Gastric Stimulator -(Enterra Therapy) it was implanted on April 2,2009. See my previous posts. This Stimulator helps the food digest in her stomach-I would have never believed it. Once every three months her primary doctor receives the programmer from medtronics for her to be checked then they talk to a individual at Medtronics and they talk to Dr. Able while she is there and they decide if it needs adjusted-then they adjust it and at that time they know how much battery is left in the usage of the stimulator-this is a godsend for some people as in my mothers case. She also elected to have the Interstem implanted as well, this item is mostly made to help the bladder however has been proven to help the bowels, her lower bowel was not working either, so we implanted this, we have the programmer in our hands at all times, we can program this ourselves. This stimulator is a god send as well, she was having fecal incontinance before this and now with both stimulators food is moving thru her system and no incontinance of any kind. Remember my mother had absolutely no food digesting!! She now is "mom" again and it is wonderful, remember if theres a will there is a way, I had contacted medtronics today to get the programmer lined up for her appt in October and I had a conversation with the lady concerning the stimulator for the sleep apnea -she was going to check into it for me and get back with me, she give me her direct line number so I can reach her-I will be finding out more and passing it on, meanwhile we will go back to mississippi for her yearly checkup with dr Able in April on 2010 - hope this info helps someone. you can also go online to the website http://www.digestivedisease.com to also find out more -it is a really good website

Implanted Sleep Device Shows Promising Early Results
Data Presented at Late-Breaking Session at the American Thoracic Society (ATS) 2010
International Conference
St. Paul and New Orleans – May 17, 2010

Three- and six-month data from the Australian first-in-man study evaluating the safety and
efficacy of the HGNS System were presented today by Dr. Eastwood, as part of the session,
“New Treatment Approaches for Lung Disease: Late Breaking Abstracts”, at the American
Thoracic Society (ATS) 2010 International Conference. The findings show the HGNS System
reduced the severity of OSA by an average of over 50%, as measured by the apnea-hypopnea
index (AHI). AHI measures the number of times per hour during sleep that a person either stops
breathing or has restricted breathing. Patients also experienced significant improvements in
symptoms, as measured by multiple quality of life surveys. Patients tolerated the treatment well,
with an average of 6.5 hours of use each night. There were no device failures during the study.

http://www.apnexmedical.com/downloads/A ... 172010.pdf

We are learning a tremendous amount about this new
therapy, which we believe will lead to even better outcomes through therapy adjustment and
patient selection. We are excited about our on-going clinical trials in the United States and
Australia, the results of which will support future applications for commercial approval.

ImThera Medical Reports Interim Data from OSA Neurostimulation European Clinical Study

- ImThera Medical, Inc. today announced interim results from its OSA European clinical study. For the study, ten patients have been surgically implanted with ImThera's aura6000 hypoglossal nerve neurostimulation device for treating Obstructive Sleep Apnea (OSA). The target population for ImThera's neurostimulation device is moderate and severe OSA patients who are non-compliant with or cannot tolerate Continuous Positive Airway Pressure (CPAP).

ImThera is releasing information on data from six patients who have had their calibrations and multiple polysomnography (PSG) studies to date. These patients have used the Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy at home for three months or longer. Four additional patients were implanted in September and their results will be reported at a later date.

The six patients vary in age, body mass index (BMI), and OSA severity. All patients had a baseline apnea hypoponea index (AHI) of 30 or greater (range 32 to 80). Patients' Oxygen Desaturation Index (ODI) had a range of 12 to 76. The primary objectives of the European Clinical Study conducted at the Universite Catholique de Louvain were safety, 50% or better reduction in the AHI, and 50% or better improvement in the ODI.

Interim results of the study are clinically significant and very encouraging for short-term data. The interim data indicates that AHI has been reduced by an average of 73% and ODI has improved by an average of 77%. On average, arousals have been reduced by 50%.

"These early results are very promising. We have seen a significant reduction in sleep related disordered breathing (decreases in apneas and hypopneas), resulting in much higher oxygen levels during sleep, and in better sleep characteristics. Patients are using the treatment every night at home, and they seem happy with the daytime effects. We see continuous reduction of their AHI over time. In addition, they appreciate the freedom the system gives them during sleep compared to the constraints of CPAP. We are confidently awaiting final data towards the end of 2010, when we plan to report our findings," said Professor Dr. Daniel Rodenstein of the Universite Catholique de Louvain, Belgium; and principal investigator of the European clinical study.

More than 800,000 patients in the U.S. are diagnosed with OSA annually. Industry estimates that as many as 38 million Americans may suffer from OSA and that approximately 20 percent of this population is getting treatment today. While CPAP is the established therapy, studies show that only 46 percent of patients comply with CPAP. The aura6000 is based on ImThera's proprietary THN Sleep Therapy , delivering neurostimulation to key muscles of the tongue during sleep.

ImThera's aura6000 system takes, on average, seventy-five minutes to implant surgically. It offers one of the world's smallest implantable and rechargeable stimulators and does not require additional sensors to function.

"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. He adds, "After a relatively simple implant procedure, patients are experiencing a substantial reduction of obstructive sleep apnea events, sleeping better and achieving improved quality of life. All patients in the European trial are happy with the therapy and utilizing it every night at home. Physicians are pleased and we are very excited with the early results from these trials and are confident that our scientific, clinical and engineering work will lead to a viable therapy alternative."

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 nighttime upper airway flow, permitting normal and restful sleep for OSA patients.
http://newsblaze.com/story/201009210516 ... story.html

Breathe Jimbo wrote: According to the reported results of the clinical trials to date, the implants appear less effective than traditional CPAP and its variants. That would seem to make the implants appropriate only for special cases, with CPAP etc. remaining the first-line therapy for many, if not most. Over time, it would be nice to see the technology and its benefits improve.

I won't even consider an implant until at least 10,000 people have had them. I would also like to know more about whether they can be used in someone with a cardiac pacemaker or defibrillator.

"ImThera's mission is to provide a safe and effective alternative for OSA patients that will not or cannot comply with CPAP,"