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Exactly right. So tell me why a highly trained podiatric surgeon cannot make a choice to use a generic, non-FDA approved laser to do the same thing at a fraction of the cost? It's the doctor who decides treatment, not medical device manufactuers or drug companies. As long as the medical device does the EXACT same thing, why not use that? Like I mentioned earlier, it is a good idea to check with your state board and your malpractice insurance carrier first. That aside, I can't see spending a fortune, or for that matter, charging a fortune for a treatment that isn't consistent. From what I read, the laser treatment for onychomycosis isn't covered by insurance--so you don't even have to please the insurance company! It's a cash procedure. It's just between you and your patient.

Can't say I have the same level of poor results myself, my planimetry results indicate far better. I have been using a PinPointe for about a year and a half. One needs to understand the technique of use of hte equipment well and in my opinion have good debridement technique, patient educaton on footwear can be important for impact tissue vitality reasons too. A magic wand it is not.

My understanding of the use of the word TEMPORARY is for sound legal reasons and most companies have to incluse some degree of circumspection. If one was to claim permanent removal then it could/would imply the person could never contract an infection in that nail ever again.

As for the PinPonte device I think it is considered to be "optimised" for its use with onychomycosis so the laser energy chain burst is specific for its purpose and does not cause a burn to the tissues. As for the FDA thing, its lable state it is cleared for use on o/m not approved by FDA. I think for the time being it is th only device of its type that can make this claim within the FDA regulations.

PinPinte temporarily makes fungus infected nails clearer. The FDA document didn't mention whether PinPinte killed fungus that infected the toenails.

Following is a list of "fungal nail lasers" that have been used "successfully":

(1) Long pulsed Nd:Yag based laser (1064nm, this type of laser is usually used for hair removal and spider vein treatment):
- PinPointe (need proper debridement prior laser treatment)
- Fontona Podiatry Laser (35ms pulse width, 4mm spot size, 35-40J/cm2, no debridement required?)
- Palomar Lux
- Aerolase (0.65ms pulse width, 2mm spot, 223J/cm2 ???)

(2) Diode laser (infrared and near infrared):
- Cool Touch Cool Breeze (1320nm, spot size 3-10)
- K-Laser (970nm and 800nm, output power 0.5-12W, continueous wave, pulsed 1Hz-20kHz)

(3) short pulsed Nd:Yag laser (Q-switched, 1064nm, this laser is usually used for tattoo removal):
- Q-Clear Q-switched laser

(4) Misc:
- CO2 laser
- DIY home treatment: I've seen somebody claiming successful treatment using a magnifier to focus sun light on the fungal infected toenails.

It seems to me any laser that is able to produce sufficient power output and to penetrate through the nail plate may be used "successfully" in the treatment of fungal nails.

"No matter if it is a white cat or a black cat; as long as it can catch mice, it is a good cat. "

Right on! I agree with everything you said.
As I mentioned in an earlier post, the thing which made me skeptical about absurdly priced therapy devices are the companies who try to sell chiropractors grossly over-priced spinal decompression tables, with the highest ones being over $120,000.00. Not making this up. There are spinal decompression tables (used to treat disc herniations) which cost $6500.00 and do the EXACT same thing. However, the absurdly priced decompression table companies use different scare tactics. Instead of saying 'you must use an FDA approved device to avoid lawsuits', they try to entice the chiropractor into buying the expensive table saying, "Ours looks impressive. You can't charge $300.00 per treatment for 15 sessions with a cheap looking table even if it does do the same thing." In other words they're selling the 'WOW' factor. I was embarrassed to be in the company of that salesman who said that, knowing some of my colleagues lapped it up.

Hi, harmish, I wonder if you file down the nails that are not thickened as well before laser treatment in order to reduce fungal load.

I have no problem with using laser to treat fungal nails once i see the randomised studies. I also do not have any problem paying $15000:00 for the machine. I DO however have a problem with having to pay the company a monthly fee of at least $4000:00 or $200.00 per client before you put on your own fees. Lets not encourage ripping off the unfortunate people who have fungal nails to pay some greedy entrepenour. Lets get real - Someone else will bring out a similar laser and sell it for what it is worth and the people left with Pinpointe Laser will be left paying per patients .

I responded to the news of the "temporary clearing" of the Pin Pointe document with the word "crooks," so I think that's probably why it was censored.

I didn't make it clear that I was referring to the manufacturer/promoter/distributor of the product. Here in New Zealand I understand they are offering exclusive "territories." If you are the first to get a laser, you can have an exclusive in your area.

Charging a high monthly fee, or use fee, is just taking advantage, using a hard edged "business" model for medical care. If it were an essential service, it would be seen as heartless profiteering. Since it's cosmetic, I guess nobody cares.

All the lasers kill fungus. You only see mushrooms growing in the shade. (DUH!) The CO2 method makes pin holes in the nail plate for administering liquid antifungals.

You probably don't want to use this method. It's tedious, requiring several treatments for nail clearance. And it smells. Even with a large commericial vacuum exiting the smoke plume directly outside, your room still smells like burnt hair. You have to use a lot of aerosol scent.

Cheers

I'm not hear to get points from anyone, but I wish the chiropractic forums were as informative and as professional as this podiatry forum. The above poster from New Zealand gave excellent information and told it like it is.
There's nothing wrong with being flip once in a while, but the chiropractic forums I joined (then quit) are all jokes.
From my handle you know I'm a chiropractor and I came here to learn about the latest in podiatry. What a pleasure it is to come here.

Have had Omega LLR training seems useful for most podiatry problems.
Also impressive from a patients view.
Use it following nail surgery for good results not convinced on mycosis.
Don't mind parting with the fee!! oh technology is a wonderful thing!!!!

Dr. Chicago:

Forums for medical professionals, such as Podiatry Arena, are only as good as the members who contribute to the site. In addition, Craig Payne, the founder and administrator, along and his other "helpers", are the main reason that Podiatry Arena is what it is today....the best source for podiatry-related information on the internet in the world.

If you are to thank any one person for Podiatry Arena, thank Craig.

__________________
Sincerely,

Kevin

**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College

e-mail: kevinakirby@comcast.net

Private Practice:
107 Scripps Drive, Suite 200
Sacramento, CA 95825 USA
My location

Voice: (916) 925-8111 Fax: (916) 925-8136
**************************************************

Dear Colleagues:

Please see the new article in the Wall Street Journal, describing the Laser ToeNail Fungus market. The article is factual, and well done by the Health Writer Laura Johannes.

A couple of sections from the article are below:

In clinical practice, results have varied, according to doctors who have used the laser. New Jersey podiatrist Anas Khoury, who has no affiliation with any laser company, says he has been using Nomir's Noveon laser for toenails for about four months and says it works in about 80% of his patients. "My patients and I are very happy with it," he adds.

Philadelphia podiatrist Warren Joseph, who is a consultant for Nomir and a former consultant for PinPointe, says: "I think it is a really interesting, viable alternative but I want to see published data." His advice to patients: "Ask for the evidence—and not just before-and-after pictures."

So far only Nomir has published evidence of efficacy, but its study is small and short term. A company-funded study of 34 patients and 26 treated toes published last year in the Journal of the American Podiatric Medical Association found that after four laser treatments, 85% of the nails showed new growth without fungus. Of the total, 65% showed at least three millimeters of clear new nail and 26% had at least four millimeters.

Here is the link:

http://online.wsj.com/article/SB1000...LAURA+JOHANNES

Best Regards,

Eric Bornstein DMD
Chief Science Officer
Nomir Medical Technologies
www.noveoninternational.com
ebornstein@nomirmedical.com
Cell: 508-380-9866

That all sounds just fine. But what about much less expensive lasers like a ND YAG 1064/532nm? They cost only $2,000 to buy one, not lease. Or a low level laser at 808nm? Those cost under a thousand dollars to own. All would be used off label but aren't podiatrist licensed to use lasers off label, meaning not FDA approved? I already know podiatrists who are using them with at least as must success as the FDA approved lasers.

I know some that are, and are getting equal results as the FDA approved fungal lasers.

ChicagoChiro:

Unless it is published in a peer-reviewed journal, ALL data is simply anectdotal.

I am the author of 15 peer-reviewed publications in the last 10 years in the laser space, across multiple disciplines of medicine, photobiology and infectious disease.

I know you seem to be very high on the "mine is as good as yours" issue, but you simply need to further educate yourself.

Cold near-infrared lasers do not kill bugs. There is peer-reviewed literture to suggest that they actually stimulate microbial growth.

One Nd:YAG is not like other Nd:YAG's if the power and pulse times are different. One could be therapeutic, where the next could very well be dangerous.

I could go on, but would suggest some reading, before simply buying a laser, and using it on patients to treat an infectious disease, or any other medical issue.

Best regards,

Eric Bornstein DMD
Chief Science Officer
Nomir Medical Technologies
ebornstein@nomirmedical.com
www.noveoninternational.com
508-380-9866

I for one agree with Dr. Bornstein and have purchased a "podiatry approved" evidence based laser> I am much more comfortable knowing the technology and science for proper care of my patients. Relying on collegues accounts for results isnt and shouldnt be considered the standard in todays data driven society. I think that buying inferior products at your patients expense is not good medicine.

I have read dozens of reviews from podiatrists who have used both FDA approved fungal lasers and generic type lasers. All reviews are by nature, 'anecdotal'. I suppose manufacturers should pick out the ones that suit them best. Reviews are mixed for both types.
The bottom line is this: If you take just a minute to learn the specifications of an FDA approved laser, you can find a much cheaper generic model. MUCH CHEAPER.
Let's not surgarcoat this. It's all about money and territory. Now if a state licensing board or a malpractice carrier forbids the podiatrist from using an off label laser, that would be different.
I've been a practicing chiropractor for over 30 years. It didn't take me 30 years to sort out the abundance of bs equipment manufacturers try to pass off as fact.
In an earlier post I mentioned Decompresssion Tables used to treat disc herniations. Some claim FDA approval (the $120,00 table manufacturers) and some don't (the $8500 manufactuers). No shock here--they both work the same.
The common thread here is this: Spinal decompression, as performed by chiropractors on those tables to treat disc herniations is not covered by insurance. It is a cash business. So the chiropractor only has to be accountable to his patient and doesn't care what insurance companies say. Likewise, it is my understanding that laser treatment for onychomycosis is also not covered by insurance as a stand-alone treatment. Again, the podiatrist only needs to be accountable to his/her patient.
When making an informed decision about what makes the most fiscal sense, don't forget to use common sense.

ChicagoChiro:

Lasers are NOT decompression tables, they are energy radiating devices, each with their own nuances and specific abilities. Here is an example of why peer reviewed data and CORRECT manufacture settings for each laser and each disease are important.

First, what is the proper "pulse width" for a procedure, and does the device give that pulse width?

Time Conversion Factors for laser “pulse” Math

1 sec = 1,000 milliseconds (ms) (103 ms)
1 millisecond ms = 10-3 = 1/1000 second = 0.001 sec
0.001 sec = 1 millisecond (ms)

1 sec = 1,000,000 microseconds (µs) (106 µs)
1 microsecond µs = 10-6 = 1/1,000,000 second = .000001 sec
0.000001 sec = 1 microsecond (µs)

10 microseconds = 1/100,000 second
100 microseconds = 1/10,000 second

Second, what is the Power density and Energy Density that you are using for the procedure, and can the laser actually put out the correct dose?

Laser Math Calculations

The Output Power of a laser device, refers to the number of photons emitted from the laser at a given wavelength and is measured in Watts. 1(W) = 1000 mW

The Power Density of a laser beam measures the potential thermal effect of laser photons at the treatment irradiation site/area of tissue. Power Density is a function of Output Power and Beam Area, is calculated in (W/cm2), and is the value is obtained with the following equation:

1) Power Density = (W/cm2) = Laser Output Power (W) / Beam Diameter (cm2)

The Total Energy delivered into a tissue area by a laser system operating at a particular output power over a certain period of time, is measured in Joules, and is obtained with the following equation:

2) Total Energy (Joules) = Laser Output Power(Watts) x Time(Sec)

It is essential to know the distribution and allocation of the Total Energy (Joules) delivered into a given tissue area, in order to correctly measure tissue site dosage for maximal beneficial tissue response.

Total energy distribution will be measured as Energy Density in (Joules/cm2).

The Energy Density is a function of Power Density and Time (sec) seconds, is measured in (Joules/ cm2) and is calculated as follows:

3) Energy Density (Joules/ cm2) = Power Density (Watts) x Time (sec)

Usually to calculate the Treatment Time to deliver a dose of laser energy to a given volume of tissue, a clinician will need to know either the Energy Density (J/cm2) or Total Energy (J), as well as the Output Power (W), and Beam Area (cm2). Treatment time can then be calculated with the following equation:

4)Treatment Time (seconds)= Energy Density (Joules/cm2) / Power Density (W/cm2)


THIS IS QUITE A LOT OF MATH for a doc to figure out with an "Off Label" laser. Who is going to do this math before they begin a procedure?

With the brand name FDA lasers, this math and the dose is generally pre-programed in for a given procedure. That is a HUGE difference.

If you disregard my above discussion for an "off label" laser, to use on your patients, without fully understanding the energy and the dose, you do so at your own risk.


Best regards,

Eric


Eric Bornstein DMD
Chief Science Officer
Nomir Medical Technologies
ebornstein@nomirmedical.com
www.noveoninternational.com
508-380-9866

Even with the high tech 'math' for FDA approved fungal lasers the reviews are mixed and no better than off label lasers with similar specifications. At least that's what I read just in this thread alone.
Nothing speaks louder than clinical success, or for that matter, clinical failure.
Years ago I was convinced double-blind studies for any medical device or drug was the gold standard that measured reliability and safety. Now I'm not so sure. Drug studies are mostly funded by the same drug manufacturers who sell those drugs, of which the majority have been pulled off the market within five years due to FDA safety concerns. So who do you believe? I put more faith in experienced practitioners than I do in drug/device manufacturers.

ChicagoChiro:

You still completely miss the point.

This is not high tech 'math' we are talking about. The equations I listed above are simple algebra, with basic constants (power output and spot size) and basic variables (treatment time and pulses within the treatment time).

This is not magic math with money to be extracted from Dr's to let them in on the magic. It is however time, effort, and education.

Written into the algorithms for Correct Dose for these systems is years of data about all of the constants and variables that show Efficacy and not Damage for the treatments being performed.

If someone wanted to follow the equations I listed above (again simple algebra) and they understood the parameters of the device they were using, the tissues they were treating, and how laser energy interacts with these tissues, they would most likely be able to calculate an effective dose with trial and error.

I have met very few physicians with the skill and or inclination to attempt to calculate the correct dose for every patient in the middle of a busy day with a laser. They would rather push one button, and have tried and tested parameters already set in the device.

Please do not leave other Docs with the impression that this is an easy task, because it is not.

I see no further need to discuss this with you. I wish you success in your therapies.

Best regards,

Eric Bornstein DMD
Chief Science Officer
Nomir Medical Technologies
ebornstein@nomirmedical.com
www.noveoninternational.com
508-380-9866

I didn't know I was discussing this with anyone in particular. It's for all to see.
My analogy to Spinal Decompression should have been clearer. The $120,000 table manufacturers have a host of computers which, according to them, calculate the 'exact' amount of traction a specific patient should be getting based on dozens of parameters such as body type, weight, MRI findings, age, medications, scar tissue, and so on. The $8500 tables don't use computers. It's up to the practitioner to determine the angle of the patient on the decompression table, how long, etc. The bottom line is this: Both the expensive tables and the cheaper tables get the same results. According to the practitioners who have used both, the results are the same. Some patients enjoyed relief while others didn't. But the type of table didn't matter even though the more expensive manufacturer said it did.
From what I've seen here and by talking to podiatrists who have used lasers to treat onychomycosis, it doesn't seem to make a lot of difference as far as clinical outcome which laser they used, a generic model or an FDA approved model. The podiatrists who got the best results instructed their patients on home care (applying topical medications) and proper hygiene. Regular debridement was also a big part of their success. Any laser seems to be about half of the overall treatmenet for onychomycosis.
I realize my opinion is just that, an opinion, but from what I've seen almost any class IIIB or IV laser would work for fungal nails as long as it's used with the other procedures I mentioned above.

I dont mean to be disrespectful, but i DO feel the type laser you use is very important. Saving a few bucks is pound wise and penny foolish. I hope you never have a malpractice case against you because if you were using an unapproved laser the opposing council will rip you apart. Dont be naive, we live in a very litiginous society and you need to be SMART and protect yourself. If this isnt a reason than as I stated before evidence based medical practices is a great reason. Your playing devils advocate to the enth degree. It doesnt make sound sense to me.

Eric, I have a question for you here: was your laser used "off labal" until you received new FDA approval that extends its usage to fundal nails?

Frederick George:


Hope you and your family are OK.

It has been reported at least 65 were killed by yesterday's earthquake in Christchurch.

Questions for those of you providing laser treatment -

1) Do you debride all infected nails or only those that have thickened?

2) After laser treatment do you have the patient apply a topical antifungal and if so for what period of time?

3) If a patient has a susceptibility to onychomycosis then I would assume that a complete treatment should include a plan to address the infectious fungal material remaining in a patient's living environment.

For avoiding reinfection what do you suggest to your patient -

a) Shoes - Do you suggest that all existing shoes (even if they've only been used with socks) be discarded or do you suggest some method of killing the fungi in them?

b) Socks - In another thread a study was linked that showed that socks contain viable fungi even after machine washing therefore they remain a source of reinfection. Do you suggest all socks be discarded?

c) Bedding - If socks contain viable fungi after machine washing we can hypothesize that sheets and blankets that have come into contact with the feet would also contain viable fungus capable of reinfection. Do you suggest discarding all bedding or some form of killing viable fungi that remains on the bedding?

d) Floor surfaces in the home?

- Do you suggest the patient use bleach or another product on hard surfaces to kill fungus?

- Do you suggest a method to remove or kill fungi on and in carpets?

e) Nail clippers? Do you suggest the patient discard the old ones or some form of cleaning before resuse on the laser treated nails?

If you pay for an exclusive on an expensive machine, or if you are selling an expensive machine, certainly that is the ONLY machine. Ask any Mercedes owner.

Does anyone else care that 65% of nails had 3mm of clear growth? So what! That is not a cure. At $1200-$1500 per treatment, not many patients can afford follow up treatment to achieve a cure.

In order for me to effect a complete cure after that first 3mm of clear nail growth, I have to laser the nails again. And again, on a monthly basis until they are cured.

I couldn't afford do that if I was paying $4,000/month lease and $200 per treatment.

That's the difference.

To prevent recurrence, Lamisil cream, or similar, every day. The patient can't rid the world, or even their house of fungus.

We are doctors. We have no superiors, only peers. We are supposed to think for ourselves.

Cheers

Fred:

How did you all fare in the earthquake? Hopefully you and your loved ones are well and things are getting back to normal in that lovely city.

__________________
Sincerely,

Kevin

**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College

e-mail: kevinakirby@comcast.net

Private Practice:
107 Scripps Drive, Suite 200
Sacramento, CA 95825 USA
My location

Voice: (916) 925-8111 Fax: (916) 925-8136
**************************************************

I asked Hamish Dow the same question (see above), but I would appreciate feedback from anyone as well.

Thank you for your kind concern, Kevin. We live outside town, so we weren't directly affected.

The earthquake has displayed New Zealanders at their best. Everyone is concerned, and have helped anyway that they can, taking in strangers who have lost their homes, students shoveling silt on their (enforced) school holiday, cooking hot meals and flying them in by helicopter for strangers who don't have power and water.

I am proud to live here.

Cheers

I specifically registered for the Podiatry Arena to afford me the opportunity to post my personal experience with the PinPonte laser treatment. I've read, start to finish, the postings beginning two years ago when I underwent the treatment. The cost was high ($1100) but included four follow up examinations and a re-treatment after one year if needed (it wasn't). In spite of the high relative cost it was for me a no brainer. I am a 61 year old male who has fought the toenail fungus battle since my year in Viet Nam (1969). I have managed to eliminate the fungus in all nails save both big toes which have proven resistant to all treatments including nail lacquer and Lamisil tabs.

In 2008 I auditioned for a long term position (in my profession 2 years is long term) with an agency that represents a large discount mail order catalog in the fashion-ware industry. To my dismay I was not hired. When I pushed the issue, the talent coordinator told me I was a shoe in until the portion covering summer clothing was conducted. Apparently this man considered toenail fungus in the same arena as AIDS. He did however schedule me for the next modeling session, six months off with the admonition that it was contingent on ridding myself of the fungus.

The long and short of it is I underwent the treatment (and deducted it as a business expense) two years ago. One treatment, two followups and I was done. My toes have remained infection free and the only routine I follow is a daily topical over the counter treatment. It matters not to me why or how the laser works; just that it did. It cleared up my condition while allowing me to continue in a career that becomes very thin as one ages.

PS
Look for my toes in the Summer 2011 Blair catalogue!

Thank you for taking the time to post your experience and congratulations on your success!

What are you using and will you continue the over the counter topical permanently?

Did you do anything to address your shoes, socks, and living environment after the treatment?