cmf ol1000

Exogen has a special strap that can be used for femoral neck fractures. Weight and height is not an issue.

 

Great place for medical advice - CP
a fcking GOSSIP website!!
do you get your investment tips off FB too?

 

"Under the Food, Drug, and Cosmetic Act (FDAC) at U.S.C. 21 §§301-97, manufacturers are prohibited from directly marketing for a use other than the FDA approved indication. The Food and Drug Administration Modernization Act of 1997 created an exception to the prohibition of off-label marketing. "

Manufacturers are now able to provide medical practitioners with off-label information in response to an unsolicited request."

Well the DJ rep in my area promotes to use Off Label and doesn't wait for any unsolicited requests! She is promoting her bone stim as a tool post non-union revision surgery! According to my clinic insiders, she does not include the OR report, just the last note that states, NON-Union. Including MEDICARE orders.

Technically you are suppose to wait 90 days post OP, even post non-union revision. And you are not suppose to withold the recent OP Note.

So when the DOJ starts pulling charts, beware!

 

If that is true and you can get proof of this, open up a whistle-blower case and you could make big bucks off of DJ. Look at what just happened with Ortho-fixx. A rep turned them in for similar infractions and made 9 million dollars just from being the whistle-blower. DJ is known to be the dirties player out there so this is most likely already in the works.

 

Patient here again
boy you reps are pretty dumb:



"Under the Food, Drug, and Cosmetic Act (FDAC) at U.S.C. 21 §§301-97, manufacturers are prohibited from directly marketing for a use other than the FDA approved indication. The Food and Drug Administration Modernization Act of 1997 created an exception to the prohibition of off-label marketing. "

Manufacturers are now able to provide medical practitioners with off-label information in response to an unsolicited request."

"The FDA does not have the legal authority to regulate the practice of medicine, and the physician may prescribe off label. Contrary to popular notion, it is legal in the United States and in many other countries to prescribe off label"



My physician prescribed my device because he said it was the best to heal my non union
and he was right!!
and I had a cast on my foot
dumbass



EXOGEN SUCKS!!!!

 

You are an idiot and are obviously drunk from the Koolaide. If a physician inquires about an off lable use, you are suppose to refer the physican to your Medical Director or an appointed official with your company. You cannot discuss off lable use.

You people continue to push the envelope meeting patients in the Recovery Rooms after they have had a non-union, revision. Technically, you are suppose to wait 90 days after any ORIF. The product should be used in the clinic setting, 90 days post op or 90 days after conservative measures have failed.
Surgeons are spilling the beans on how you people market. Your day in the spotlight will soon be here.

 

"Under the Food, Drug, and Cosmetic Act (FDAC) at U.S.C. 21 §§301-97, manufacturers are prohibited from directly marketing for a use other than the FDA approved indication. The Food and Drug Administration Modernization Act of 1997 created an exception to the prohibition of off-label marketing. "

Manufacturers are now able to provide medical practitioners with off-label information in response to an unsolicited request."

"The FDA does not have the legal authority to regulate the practice of medicine, and the physician may prescribe off label. Contrary to popular notion, it is legal in the United States and in many other countries to prescribe off label"


REREAD DUMBASS


"Under the Food, Drug, and Cosmetic Act (FDAC) at U.S.C. 21 §§301-97, manufacturers are prohibited from directly marketing for a use other than the FDA approved indication. The Food and Drug Administration Modernization Act of 1997 created an exception to the prohibition of off-label marketing. "

Manufacturers are now able to provide medical practitioners with off-label information in response to an unsolicited request."

"The FDA does not have the legal authority to regulate the practice of medicine, and the physician may prescribe off label. Contrary to popular notion, it is legal in the United States and in many other countries to prescribe off label"

 

The physican can certainly PRESCRIBE OFF LABLE, but that does NOT mean you can PROMOTE off LABLE or PAY them to use your Product. Keep drinking the KOOLAIDE that your training department Pours. Your ship will go down and nobody in corporate will protect you.

 

Label.....L-A-B-E-L...LABEL!!!

 

Yeah, I am sure that person is the first one on the planet, who has typed in a wrong key. Don't you have better things to do than to correct peoples spelling? Typical over hyped DonJoy rep whose product suxs, so you have to play Bully.

It's widely known that the only way you guys can get your product to work, is to place the unit on patients who have just had a revision. Most of them are going to heal just fine anyway. Try using a cmf ol1000 on a non-union femur (without ORIF revision) or a scaphoid. The purpose of payers paying for bone stimulators is to AVOID revisional surgery. This is one reason why carriers are AUDITING Files.

 

Patient here again
boy you reps are pretty dumb:



"Under the Food, Drug, and Cosmetic Act (FDAC) at U.S.C. 21 §§301-97, manufacturers are prohibited from directly marketing for a use other than the FDA approved indication. The Food and Drug Administration Modernization Act of 1997 created an exception to the prohibition of off-label marketing. "

Manufacturers are now able to provide medical practitioners with off-label information in response to an unsolicited request."



"The FDA does not have the legal authority to regulate the practice of medicine, and the physician may prescribe off label. Contrary to popular notion, it is legal in the United States and in many other countries to prescribe off label"



My physician prescribed my device because he said it was the best to heal my non union
and he was right!!

 

Pretty dumb physician who is probally getting some sort of kick back. Efficacy for cmf ol1000 is the lowest of all the stimulators. 67% efficacy right on your Web Site.

Many of your reps get the business by doing a Buy and Bill Scheme with clinics. Which violates many payer contracts as well as the Stark Law.

So of course, a physican, who buys and bills your product, is going to tell the patient it is the Best. Because he is profiting from it.

 

jail time for DJ reps.

 

No. He prescribed it because he buys and bills your device exclusively and makes over a $1,000.00 bucks profit per unit! Of course he is going to tell his patients, "it's the best". It's the best for his Wallet!

 

Actually, the heal rate is even lower: 60.7% for non-unions. By far the lowest heal rate for any bone stim on the market. From DJ's own web site:

https://www.djoglobal.com/products/cmf/cmf-ol1000

 

Two studies, both by Emami et al., were cited: one was published in the Journal of Orthopaedic Trauma and one, in Clinical Orthopaedics and Related Research.

The first states that Exogen Inc. provided the ultrasound devices used in this study. The authors have received nothing else of value. The second article provides no information about financial support of the study.

Both studies by Emami et al. were prospective, randomized, blinded, and placebo-controlled.

Both showed NO difference in healing between the patients who were treated with ultrasound and those who were not.

reread that again ok..........

Both showed NO difference in healing between the patients who were treated with ultrasound and those who were not.



EXOGEN = PLACEBO!!!

 

The one, single study that DJ has for its stim showed 60% healing for non-unions. What is even worse is that two patients from the failure group had to undergo AMPUTATIONS of their limbs!!!!
Why on earth would a physician prescribe it? Purely money and greed, it has absolutely no benefit to the patient.

 

That study has so many flaws it's ridiculous! Keep up with the new Data, AHole!

 

Yep. Any surgeon who uses this product is using it out of greed or laziness. Who in their right mind would use a product that is 60.7% effective over products that are 86% effective. Greed!

 

Two studies, both by Emami et al., were cited: one was published in the Journal of Orthopaedic Trauma and one, in Clinical Orthopaedics and Related Research.

The first states that Exogen Inc. provided the ultrasound devices used in this study. The authors have received nothing else of value. The second article provides no information about financial support of the study.

Both studies by Emami et al. were prospective, randomized, blinded, and placebo-controlled.

Both showed NO difference in healing between the patients who were treated with ultrasound and those who were not.

reread that again ok..........

Both showed NO difference in healing between the patients who were treated with ultrasound and those who were not.



EXOGEN = PLACEBO!!!