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Source: Ventus Medical
New Therapy Now Available in New York City Area for Patients With Obstructive Sleep Apnea
Leading New York City Sleep Specialist Treating Patients Who are Among the 50 Million Americans With Sleep Apnea

LAKE SUCCESS, N.Y. and BELMONT, Calif., Oct. 7, 2009 (GLOBE NEWSWIRE) -- North Shore Pulmonary Associates, PC, a leading New York sleep disorder treatment medical practice, and Ventus Medical Inc., a privately held medical device company, today announced the availability of a new therapeutic option for the treatment of Obstructive Sleep Apnea, or OSA, in the New York City area.

OSA is the most common type of sleep-disordered breathing. OSA is a chronic disorder characterized by pauses in breathing or shallow breaths during sleep. OSA occurs when the upper airway near the back of the mouth collapses during sleep, obstructing the airway, preventing air from entering the lungs. OSA has a number of potential serious side effects including excessive daytime sleepiness, increased risk of high blood pressure, heart attack, stroke, diabetes, obesity, increased or worsening risk of heart failure, and increased likelihood of driving or work-related accidents. An estimated 50 million people in the United States have OSA, but only 15 percent are diagnosed. In 2009 alone, an estimated 2.4 million people will be newly diagnosed with mild-to-moderate OSA.(1)

"OSA is one of the most common sleep disorders for which I treat patients, and if left untreated, can lead to serious health consequences related to cardiovascular disease, obesity and diabetes," said Jay Steven Berland, MD, FCCP, and Medical Director of North Shore Pulmonary Associates Sleep Apnea Program, Lake Success, NY and the Ultimate Health Sleep Disorders Center, New Hyde Park, NY. "While there are several effective treatments for OSA, the patients I treat are increasingly seeking therapeutic approaches that are more convenient, easy to use, and have minimal impact on their lifestyle. PROVENT Therapy is one of these options."

PROVENT Sleep Apnea Therapy is a simple, non-invasive treatment for OSA. PROVENT Therapy is a nightly-use prescription device attached with a hypoallergenic adhesive and placed over the nostrils. PROVENT Therapy works across mild, moderate, and severe OSA.

PROVENT Therapy utilizes a proprietary MicroValve technology developed by Ventus Medical. During inhalation, the valve opens allowing essentially normal airflow, and during exhalation, the valve closes, limiting airflow through two small openings, which increases expiratory pressure, helping to keep the airway open.

PROVENT Therapy has several advantages. It is easy to use, discreet and portable, powered by the patient's own breathing (no electricity required), simple, and disposable.

"I live an extremely physical and active lifestyle and when I was diagnosed with OSA in 2004, I was concerned about how treatment may limit my activities," said Maria Tonkiss-Jiminez, a resident of Middle Island, NY and patient of Dr. Berland. "I tried several treatment options, including a CPAP machine, which I found uncomfortable and made sleeping throughout the night difficult. I began using PROVENT Therapy in 2009, now have my OSA under control, and am enjoying my life's pursuits without interruption."

Currently, PROVENT Therapy is only available in limited locations in the United States, including Long Island, with the assistance and support of professional sleep physicians. PROVENT Therapy may not be appropriate for everyone. For more information, please call 1-866-542-8510 or visit www.ventusmedical.com/PROVENT.

About Sleep-Disordered Breathing

Sleep-disordered breathing broadly refers to a group of disorders characterized by abnormalities of breathing pattern (such as stopping breathing) or the abnormal reduction in the volume of breaths while sleeping. OSA is the most common type of sleep-disordered breathing. An estimated 50 million people in the United States suffer from OSA, which occurs when the upper airway (near the back of the mouth) collapses during sleep, obstructing the airway and preventing air from entering the lungs. OSA is caused by multiple factors, including sleep-induced relaxation of the throat muscles and tongue, enlarged tonsils and adenoids, an abnormally small airway diameter in the back of the mouth and throat, and extra soft tissue in and around the throat due to being overweight.

About Dr. Jay Berland

Jay Steven Berland, MD, FCCP is Medical Director of the North Shore Pulmonary Associates Sleep Apnea Program, Partner at the North Shore Pulmonary Associates, PC in Lake Success, NY, and Medical Director of the Ultimate Health Sleep Disorders Center in New Hyde Park, NY. Dr. Berland specializes in the diagnosis and treatment of patients with sleep related breathing disorders. Dr. Berland is board certified in Sleep Medicine, Pulmonary Medicine, Critical Care and Internal Medicine.

Dr. Berland is a Fellow of the American Academy of Sleep Medicine and the American College of Chest Physicians, and a Diplomate of the American Board of Sleep Medicine. Dr. Berland received his medical degree from the State University of New York Health Science Center in Syracuse, NY. He received subspecialty training in Sleep Medicine, Pulmonary and Critical Care Medicine at New York Presbyterian Hospital's Weill Cornell Medical Center in New York City.

About Ventus Medical

Ventus Medical is a medical device company focused on improving the lives of patients with sleep-disordered breathing. Located in Belmont, California, Ventus Medical has developed and markets PROVENT Therapy, an innovative, clinically-proven treatment for OSA. Existing OSA solutions do not always meet patients' needs. Through truly innovative technology, solid clinical evidence, and a focus on the patient, Ventus Medical seeks to deliver consumer-preferred, physician-recommended solutions. The company is privately-held and funded by De Novo Ventures, Mohr Davidow Ventures, and Johnson & Johnson Development Corporation.

Important Information About PROVENT Sleep Apnea Therapy

PROVENT Therapy is indicated for the treatment of obstructive sleep apnea. PROVENT Therapy is a prescription-only product and should be used only after consultation with a physician.

The PROVENT Nasal Device should not be used if you have any of the following conditions:


* A severe breathing disorder (including respiratory muscle weakness,
bullous lung disease, bypassed upper airway, pneumothorax,
pneumomediastinum, etc.)
* Severe heart disease (including heart failure)
* Pathologically low blood pressure
* An acute upper respiratory (including nasal, sinus, or middle ear)
inflammation or infection, or perforation of the ear drum

(1) Young T, Skatrud J, Peppard PE. Risk Factors for OSA in Adults. JAMA. Vol 291, No. 16, pp 2013-2016.

CONTACT: Lazar Partners
Erich Sandoval
805-667-8402
esandoval@lazarpartners.com

Views: 102

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I am still skeptical about this treatment.
Rock, what is it about this treatment that makes you skeptical? At first look, it seems like an exciting possible alternative for some people...having said that, I freely admit I don't know jack squat about any of this!!!!!! lol But it's extremely interesting to me.

I have CAD and one stent. Take a lot of cardiac meds. Would that disqualify me for this treatment?

Susan McCord
Since most new therapies that come along do not change the standard of care, I share Rock's skepticism. However, the general concept of self-generated resistance pressure makes sense to my little mind. Since this would be a much more cost-effective therapy if valid, I am hopeful.
It would be great if they work well, but I am very skeptical about them. I could see these working if the obstruction happened during exhale; but the obstruction happens during inhale -- it seems bass ackwards. I am also wondering how well the adhesive will work.
Hello All,

Has anyone tried this? I am very new to the universe of sleep apnea. I have just been diagnosed with severe OSA and will be starting CPAP, probably, next week. Having gained a really good overview through this forum, I have fortunantely become attuned to the dangers of OSA and am determined to be a compliant CPAP user.

However, prior to getting CPAP, I have been aware of how my breathing sounds and feels differently just as I am falling off to sleep. It becomes shallower in 5 steps, decreasing from reaching my abdomen, to finally only entering my throat. At that point, my throat would stayed closed for a while - I don't know how long - because I swallow to open my throat, but then the 5 step decreased breathing process begins again - right away! It was only 2 days ago that I got my sleep study report and I learned about my low oxygen level so it has only been 2 nights that I have been sensitive and recognizing my breathing pattern. Before I knew I had OSA, I was getting very little Stage 3 and REM, but once I did know, I wasn't able to go to sleep at all! So I tried to think of some way I would feel assured that I would swallow more frequently than the time it took for the full 5 step decrease 'til my throat was closed and had stayed closed for a little while - about 30 seconds - without my having to stay awake to swallow - otherwise I was not going to be able to go to sleep. And then about 4 AM, I got the idea to try using a Tic-Tac to promote swallowing for me. I know the sugar isn't a great idea, but it's small so there's less chance I'll choke if I accidentally swallow it, and I need to try to get some sleep. And it worked! And I tried it again last night and, thank goodness, it worked again. In case anyone wonders . . . no, I am not going to continue with Tic-Tacs, I am going to get CPAP.

But, I think, that anything, that will either keep the throat open, or open the throat every time it starts to close, could work. So back to the Provent device . . . Tim makes a good point that the obstruction happens during inhale - and Provent limits pressure during exhale - but IF - BIG "IF" - that exhale pressure occuring on each and every exhale works along the lines of my temporary "Tic-Tac remedy", that is, that Provent either keeps the throat open or opens the throat within, at least, 1 or 2 breaths - absolutely consistently and reliably - then wouldn't it be accomplishing a similar purpose as CPAP for those who are using only room air?

So, while skeptical, I am going to check it out with the company and will post what I find out.

Best to all,
Renee
I am always skeptical of new apnea stuff. I have to be it is my job. I don't think that you or anyone else in your position could use it. Also i worry about the negative pressure that it seems to build up. that whole warning about the eardrums has me thinking. it is to early to tell though. I have been watching this from a distance. I would really like to get some feedback from someone who has tried it.

susan mccord said:
Rock, what is it about this treatment that makes you skeptical? At first look, it seems like an exciting possible alternative for some people...having said that, I freely admit I don't know jack squat about any of this!!!!!! lol But it's extremely interesting to me.

I have CAD and one stent. Take a lot of cardiac meds. Would that disqualify me for this treatment?

Susan McCord
It does not work for mouth breathers, and it is not supposed to be used when you have a cold. This would mean that a CPAP would have to be used when you have a cold.

" Adverse reactions to Provent Professional Sleep Apnea Therapy may include mouth breathing which may worsen your snoring or OSA; nasal, sinus or middle ear discomfort; nose bleed; dry mouth; nostril pain or dilation; and headache."

http://www.proventtherapy.com/pdfs/pdf01_PatientInstructions.pdf

It also says:

Contraindications

The Provent nasal appliance should not be used if you have any of the following conditions:

• A severe breathing disorder (including respiratory muscle weakness, bullous lung disease such as emphysema, bypassed upper airway, pneumothorax, pneumomediastinum, etc.).

• Severe heart disease (including heart failure).

• Pathologically low blood pressure.

• An acute upper respiratory (including nasal, sinus or middle ear) infl ammation or infection, or perforation of the ear drum.


There is a web site with more information at http://www.proventtherapy.com/
Hello All,

I posted previously about this and mentioned that I was going to contact Provent and would get back with what I found out ... Well I left a phone message for Provent on an answering machine about a week ago and have not heard back and since I am going to be starting with CPAP next week, I am going to concentrate on that for now. But I thought it might be of interest that my request for info didn't receive a response.

Wishing you restful sleep,
Renee
Thanks Cindy

Cindy Brown said:
I just read (well I read it before I left for work) the abstract with the results of their study. This product doesn't look like it's not very effective at all. The results show an improvement of approximately 50% which isn't too bad when you have mild to moderate sleep apnea but if you have sever sleep apnea then you're still having significant symptoms. It also stated that sleep architecture was unchanged with and without therapy. Meaning if you had crappy sleep before using this device you'll have crappy sleep after. Isn't the sleep what we're all trying to get more of?

Cindy

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