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Has the low voltage machine been FDA approved for US yet?

Posted by Beverly on 11/16/01 at 18:03 (064885)

I can't remember the name of the low voltage machine that is used in Canada. But I recall about six months ago seeing a foot/ankle orthopedic specialist who said that when it gets approved and becomes available in the US, it will be dramatically less expensive than the current EWST treatments although it may require multiple zaps.

I am primarily interested in this for my achilles tendonitis. With it, I can point to 'the spot.' I also have PF, but I've been told I'm not as good a canidate for EWST on the PF because the pain is diffused across my heel and sometimes arch... not in one spot.

So, what is the scoop on the low voltage machine becoming available in US?
Thanks,
Beverly

Re: Has the low voltage machine been FDA approved for US yet?

BrianG on 11/17/01 at 22:44 (064920)

Hi Beverly,

Only one ESWT machine has been approved by the FDA for heal pain treatment in the US, the Ossatron. I think (and hope) that we'll see more machines within the next year. Hope you can hold out that long. Good luck

BCG

Re: Has the low voltage machine been FDA approved for US yet?

Dr. Zuckerman on 11/18/01 at 06:43 (064929)

The ossatron is an approved Class three devide for plantar fasciitis. It isn't approved for achilles tendonitis or will there be any machine in the near future going thru FDA trials for Achilles Tendonits. We use the orbasone ESWT machine for chronic achilles tendonitis which is a very effective ESWT treatment . We have found the use of ESWT very effective for chronic Achilles achilles just as it has been shown in Europe and Canada.

As far as additional ESWT machines that would be great, but I doubt there will be any available for achilles tendonitis

Re: Has the low voltage machine been FDA approved for US yet?

Beverly on 11/18/01 at 13:49 (064951)

Dr. Z,

Thank you for answering my question. Now that I've reviewed treatment locations, it was the Dornier machine that the doctor's office said they hoped to get when it becomes available here. Has that been used for achilles tendonistis? I'm not aware of the Orbasone machine being available anywhere in Texas.

In the meantime, besides gentle stretches, massage, rest, shoes with at least a one inch heel height, wrapping with activity, and custom orthodics ( all of which I am doing), do you have any other suggestions for the achilles tendonitis? I've been hesitant to use the nightsplint since getting the AT since it pulls on it, but would it be helpful? Also, I've seen an add for achilles support called 'Pro-Tec Achilles' Tendon support.' I think it was developed at Mayo's. It is a small/light. strap that goes around the ankle and then under the heel. (Footsmart.com)
Thanks,
Beverly

Re: Question just above is for Dr. Z. Thanks

Beverly on 11/18/01 at 13:49 (064952)

eom...

Re: Has the low voltage machine been FDA approved for US yet?

DR. Zuckerman on 11/18/01 at 21:16 (064967)

Hi Bev,

You have covered all that I can think of short of surgery or ESWT. I will let you know about the Dornier ESWT as I have been in contact with them.
The only problem I see is that the Dornier has applied and will recieve FDA class three for plantar fascia treatment . The use for Achilles tendonitis will depend on the company . Most companies should allow the doctor to use the machine for any condition that he has experience in and feels comfortable. I have no idea what the position will be Dornier

Re: Has the low voltage machine been FDA approved for US yet?

BrianG on 11/17/01 at 22:44 (064920)

Hi Beverly,

Only one ESWT machine has been approved by the FDA for heal pain treatment in the US, the Ossatron. I think (and hope) that we'll see more machines within the next year. Hope you can hold out that long. Good luck

BCG

Re: Has the low voltage machine been FDA approved for US yet?

Dr. Zuckerman on 11/18/01 at 06:43 (064929)

The ossatron is an approved Class three devide for plantar fasciitis. It isn't approved for achilles tendonitis or will there be any machine in the near future going thru FDA trials for Achilles Tendonits. We use the orbasone ESWT machine for chronic achilles tendonitis which is a very effective ESWT treatment . We have found the use of ESWT very effective for chronic Achilles achilles just as it has been shown in Europe and Canada.

As far as additional ESWT machines that would be great, but I doubt there will be any available for achilles tendonitis

Re: Has the low voltage machine been FDA approved for US yet?

Beverly on 11/18/01 at 13:49 (064951)

Dr. Z,

Thank you for answering my question. Now that I've reviewed treatment locations, it was the Dornier machine that the doctor's office said they hoped to get when it becomes available here. Has that been used for achilles tendonistis? I'm not aware of the Orbasone machine being available anywhere in Texas.

In the meantime, besides gentle stretches, massage, rest, shoes with at least a one inch heel height, wrapping with activity, and custom orthodics ( all of which I am doing), do you have any other suggestions for the achilles tendonitis? I've been hesitant to use the nightsplint since getting the AT since it pulls on it, but would it be helpful? Also, I've seen an add for achilles support called 'Pro-Tec Achilles' Tendon support.' I think it was developed at Mayo's. It is a small/light. strap that goes around the ankle and then under the heel. (Footsmart.com)
Thanks,
Beverly

Re: Question just above is for Dr. Z. Thanks

Beverly on 11/18/01 at 13:49 (064952)

eom...

Re: Has the low voltage machine been FDA approved for US yet?

DR. Zuckerman on 11/18/01 at 21:16 (064967)

Hi Bev,

You have covered all that I can think of short of surgery or ESWT. I will let you know about the Dornier ESWT as I have been in contact with them.
The only problem I see is that the Dornier has applied and will recieve FDA class three for plantar fascia treatment . The use for Achilles tendonitis will depend on the company . Most companies should allow the doctor to use the machine for any condition that he has experience in and feels comfortable. I have no idea what the position will be Dornier