Vibralung® Acoustical Percussor receives FDA 510(k) Clearance

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mmcpeck

New member
Hi everyone,

I don't want to be overly commercial and will keep this as brief as possible, but I just wanted to announce that Westmed, Inc. received FDA 510(k) clearance to market for its Vibralung® Acoustical Percussor on May 23, 2014. The official press releases will occur soon and the product launch will take place in late summer. The Westmed website is being modernized and updated and the new web site will also be relaunched soon along with a comprehensive family of web pages devoted to the Vibralung. I'll make an announcement when those sites are up and running.

The operating theory of the Vibralung Acoustical Percussor is to vibrate the "column" of air in the tracheobronchial tract, using sound waves, which also vibrates the different airways and the mucus at their specific Resonant Frequencies (RFs). This is called "sympathetic resonance," and a good real-world example is when a car pulls up next to yours with its stereo system pumping out at such extremely high volume that it causes your car to rattle and vibrate. This is what is accomplished in the lungs during therapy with the Vibralung.

In short, the Vibralung Acoustical Percussor is an acoustic airway clearance device that applies sound waves directly to the airway opening through a mouthpiece during both inspiration and exhalation while the subject is breathing normally. A veterinary version has been in use for many years to clear the lungs of race horses and now Westmed has developed a version of that device that is suitable for humans. The sound waves that are generated include "random noise" between 5 and 1,200 Hz plus 3 different modes of sequential tone pulses that are applied in different frequency ranges during a 10 minute timed treatment session: Low 5 - 200 Hz, Medium 5 - 600 Hz, and High 5 - 1,200 Hz. Simultaneous aerosol therapy can also be given via the Westmed Circulaire II high-efficiency aerosol drug delivery system.

The device consists of 2 components: an ergonomically shaped Hand-Held Transducer (HHT) connected with a tiny wire to a small, portable battery-operated Treatment Control Unit (TCU).

The reason for the different ranges and sequential frequency progression during the treatment is because each airway segment has its own RF, determined in part by its length and diameter. Treating the lung with a single frequency is likely to be effective on some airways but bypass many others that have different sizes and therefore different RFs. Treating the lung with a progression that includes hundreds of discrete frequencies will eventually expose virtually the entire airway system to acoustic vibration at some point during the treatment.

We will make additional announcements in the future and will also formally communicate with the CFF as the launch date becomes set. So please watch for the announcements this summer and stay tuned for further information.

Thank you for allowing me this brief announcement.

Mike

Michael McPeck, RRT FAARC
Director of Clinical Education
Westmed, Inc.
Tucson, AZ
 
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ecsnut

New member
Hi there...as interesting as this is...I have a problem with companies coming on this site and soliciting. I do not see any other companies coming to give their information...just saying. I would have appreciated a link to check out...but this is our site. ECS
 
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Joe2007

Guest
ecsnut said:
Hi there...as interesting as this is...I have a problem with companies coming on this site and soliciting. I do not see any other companies coming to give their information...just saying. I would have appreciated a link to check out...but this is our site. ECS
Click to expand...

i welcome their announcement. This sounds like a legitimate beneficial and FDA approved device. I have not seen announcements about it elsewhere. Probably took time and money to get through approval process. It's not like some snake oil pitch like negative ionized water which has appeared on this board.
 
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politicaljules

New member
I think it is great news!!

I have been following the Vibralung device for awhile now, and I welcome their announcement here as well. I saw that it uses sound waves that break up the mucus, and can help people who do not understand the need, or the correct way to huff cough during the vest and breathing treatments. My kid has an intellectual disability, and it is hard teaching her to cough correctly. This device is supposed to help with that, as well as break up the mucus.

As I understand it, certain sound wave frequencies are very effective at breaking up mucus, and this device directs the sound waves into the airways rather than through the chest wall.

It is a different kind of a device unlike one that is held onto the chest, like the Frequencer. Don't get me wrong, I liked the Frequencer a lot, but when I tried to get more information about it, I could never get them to call me back. I had an old brochure, and one number was disconnected, so I looked them up on the internet and tried to contact the Frequencer people, but was unsuccessful.

The only thing I could ascertain about the Frequncer is that it is a company in Canada, and very hard to get approval here in the states. I kinda gave up on it and thought that company was either very small, or not selling enough units to expand, or was not even going to continue in the Cf market.

However, when I first heard about the Vibralung, I contacted them by email, (I wanna say it was a year ago or so, but don't quote me on that), they wrote me back immediately saying they were still trying to get FDA approval. I was disappointed because I knew how the FDA worked, & I thought it would be many many years before I heard from them again. My hopes of sound wave technology helping my kid were dashed.

But now I am excited again, and I think this is great news. I really hope our family gets a chance to try it out very soon!

And if it works, it can be a device that will help people like my kid.

If it does not work, obviously it wont make it very far, but I think we should be open to new technology to help combat this disease that is attacking lungs, bodies, and shortening lives.
 
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cfgf28

Guest
Is this device the same as the metaneb? My fiance was just admitted for a tune up and they have him alternating the vest withe a machine called the metaneb and it is one that works when you are breathing in and out. The respiratory tech has him use it with hypertonic. He likes it better. The the vest and says it's faster but was told it hasn't been approved for home use yet..
 
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Liza

New member
Thank you, Usual Suspect, for the link. I either missed that it was actually put in your mouth or it wasn't mentioned in the initial post.

This is quite interesting though. My first thoughts came after the video said that it takes 30 minutes to complete the therapy, wondering if there are breaks in treatment. I know my daughter would not be able to breath just through her mouth for half hour straight.

I think it's kinda good that they came on here to let the community know about this new FDA approved device. Sometimes, the word doesn't get out soon enough from clinics. Many of them get fixated on just one type of CPT and "everyone" should be doing that one kind. I speak from my girls having been seen at many different CF clinics, due to moving around in the military. Once the vest became popular, they were always asking us why we didn't use it, that we should use it, try it, try it, again and again at each different clinic. So, they tried it a few different times/ places before we finally said, no more.

I don't feel this was a sales pitch, just a FYI. I, myself, hadn't heard anything about this prospective new product. I think this was the perfect spot, Airway Clearance Technique. Now if they were posting repeatedly or in a different forum folder, that'd be def. wrong.
 
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UsualSuspect

New member
Liza,

After reading the statement by Mr. McPeck again, it says the treatment sessions were 10 minutes. However, with vest therapy, the amount of time people spend doing it seems to be all over the map. What sounds really intriguing to me is the range of 5-1200Hz, and not having to manually position it.
 
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Rosie55

New member
This does remind me of the metaneb, which my daughter has used in the hospital and likes a lot! I'm just finding out about it, does anyone know if insurance is covering it? Or what it costs? I like the fact that it can be done simultaneously with aerosol therapy.
 
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mmcpeck

New member
I will try to briefly answer your questions. Although all airway clearance devices vibrate the boundary between secretions and the airway surface, the mechanisms used to do so vary widely, thereby offering clinicians and patients many choices to find what works best for individuals. The Vibralung Acoustical Percussor differs from the MetaNeb in a number of ways. It does not require a powerful air compressor to operate by itself, without aerosol. However, when simultaneous aerosol therapy is desired, its optional Circulaire II aerosol delivery device can operate effectively from any air compressor because it uses a reservoir to conserve aerosol that would be wasted and allow it to be inhaled instead. The Vibralung effectively vibrates airways and secretions gently, with sound waves applied directly to the airways, rather than with forceful airway pressure spikes. Aerosol delivery is much better owing to the interface with the Circulaire II high-efficiency aerosol delivery system and the fact that aerosol particles are not accelerated and "slammed" into the back of the throat. Instead, the reservoir system delivers more drug in each breath. The Vibralung is battery-operated and extremely portable. Because it is relatively new, it is not yet widely covered by insurance although a number of patients have been successful at achieving coverage. As with all new devices, insurance coverage will improve over time. The Vibralung readily transitions from hospital to home. I hope you find this brief overview and information helpful. Please visit the Vibraung web site for further information.

Michael McPeck, RRT FAARC
Director of Clinical Education
Westmed, Inc. Tucson, AZ
www.vibralungACT.com

 
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believingjesus

Banned
Does anyone know anything about the Vibralung percussor? Is anyone getting it approved through insurance especially if you already have a Vest system? I have tried to click on the links but they do not work! Mmcpeck - your links do NOT work. I was wondering the cost and also the size as it sounds portable. We have the Vest (the newer smaller version) and the Flutter Valve. We really need something smaller that will pass through customs easily as my son has to fly internationally with his job.

Also: (The Flutter Valve is small but really is not effective at least for my son).
 
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believingjesus

Banned
I too would like to know if anyone is using the Vibralung? Can it be sterilized between uses? Is it effective like the Vest? I was looking for something portable and this is and is also small (battery-operated). If anyone knows about this I would appreciate your input. I have called the number and visited but am confused about if it can be cleaned properly. Also does insurance cover any of it if you already have a vest?
 
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wpierson7

New member
believingjesus: I came here to gain info and joined the board just to answer your question. My dad just received the device earlier today. The nurse who provided training said the mouth piece only needs to be sterilized about once a week. I believe she said to use peroxide or alcohol. There is another detachable part that only needs to be rinsed off with water if saliva or mucus happens to get on it. I think that can be done as needed. She stated that studies showed no significant difference in effectiveness between the vest and Vibralung. However, the Vibralung is apparently much easier to use and maintain. I don't have an answer to your last question, but she did state that every device she has issued thus far has been approved. The company is starting people on 30-day trials before submitting to insurance. My dad has only taken one treatment since receiving it this morning, so I'm not sure how effective it is for him yet. Hopefully this info helped!
 
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believingjesus

Banned
Thank you wpierson! I really wanted to hear from someone who is using it so I appreciate your response. Can you please keep us posted as to how it is working since he just got it? I called but the representative is no where near where we live and I didn't want them to have to travel to show me the device and then I decide not to get it. I didn't feel comfortable just looking at it online as the representative suggested. He also told me it retails for $4,000 but if insurance would not pay they could sell for $2,000 so it is a lot of money. I really have difficulty with how they say to clean it. I know that maybe it is standard but it says you can clean with Clorox wipes and that makes me nervous as I know wipes have been found to sometimes contain bacteria that was unknown when it is sold but later found after people have used them. I also am unsure about only cleaning the mouthpiece once a week as the representative also told me over the phone. Does your dad have cystic fibrosis? I just feel so more comfortable being able to boil things for sterilization. I really do like the Vibralung though as it looks like it would really work effectively and would be portable and small. Please keep me updated about how it is going. I really appreciate you logging on and letting me know about the Vibralung! Thanks so much!
 
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