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Dornier FDA approved for PF today

Posted by DR Zuckerman on 12/02/01 at 07:23 (065892)

Just received a phone call from Dornier . They are FDA approved for pf
Hope this is helpful

Re: GREAT !!!!!!!

BrianG on 12/02/01 at 18:23 (065933)

This sounds GREAT to me. So, now we have 2 machines in the US approved for treating PF, the Ossatron and the Dornier. Do you happen to know if it was the Epos Ultra machine? This is the one that had trials in Boston, Atlanta, Detriot, Canada and Germany a couple years ago. Now, if only the insurance companies come on board also!!!!

This is progerss, slow but sure.

BCG

Re: GREAT !!!!!!!

DR Zuckerman on 12/02/01 at 19:03 (065935)

It was the epos. Only time will time, how great class three classification
approval will be, and the cost of the treatment is the only thing that will bring insurance on board. Will inform this board when I I know details that I can vertify.

Re: GREAT !!!!!!!

Pauline on 12/02/01 at 19:54 (065937)

Brian,
This is the one you were waiting for and the one sitting in my Orthos office. The big guys have this one so it will be interesting to see if they get the insurance coverage now. I think it will take a while, but it will come. I know my doc is waiting to use it on some sports figures because he treats several teams here. Of course they (the
teams) can cover their costs pretty well.

I can't see them turning down places like Mass General, U of M. UCLA, Henry Ford, Emory. They do the big kidney stuff so if they are already using Dornier for I think they will push for this new Dornier to be covered too.

It's a waiting game now. These hospitals can't afford to have Dornier's machine just sitting in their centers with no money coming in collecting dust. I personally think they will lead the way for insurance coverage. That would be wonderful for many PF sufferers.

Re: GREAT !!!!!!!

BrianG on 12/02/01 at 21:11 (065948)

I went to the FDA site, but couldn't find anything. Maybe it will take a few days for it (the site) to be updated? Mass General was in on the last trials. I called, but was too late. They, MGH, probably had enough of their own PF patients to fill the study.

Outside of a miracle, this is my last chance.
BCG

Re: GREAT !!!!!!!

DR Zuckerman on 12/02/01 at 21:23 (065950)

Lets hope they keep it out of the surgical centers and into the office. Now that would keep the cost down and maybe bring in the insurance companies.

Most of the big insurance companies want long term outcome studies not FDA trials. This can take years

Re: For Dr Z: Maybe, maybe not !

BrianG on 12/05/01 at 22:35 (066287)

Hi Dr Z,

Could you please check your sources for the Dornier. I contacted someone from the FDA, and they are not aware of it being approved.

Thanks
BCG

Re: For Dr Z: Maybe, maybe not !

DR Zuckerman on 12/05/01 at 23:03 (066292)

It isn't finalized but they are going to get it within the next few weeks.
The final labeling process isn't done

Re: GREAT !!!!!!!

Pauline on 12/10/01 at 20:31 (066670)

Well it sure took long enough. I've been petting that machine for over
18 months and now I don't need it. But at least I know it's ready to go when my next PF case appears.

Brian, sounds like your on your way to Mass General when and if insurance coverage comes through. I hope it does the trick for you so you can close this chapter in you life and move on to one pain free.

I'll try calling my doctors office to see if they are getting insurance coverage after the first of the year. I don't know if he has used it on anyone yet since I haven't been back to see him.

Dr. Z if they keep the machine in these hospital medical centers would physicians have to be on staff to use it or would it be open to any physician?

Re: GREAT !!!!!!!

DR Zuckerman on 12/10/01 at 21:48 (066675)

I would have to say yes to the on staff question. That is the way it worked for the ossatron at the Healthsouth surgical center that I belong to in my area. It would be wise to re-consider that position . It takes a lot of doctors to make the ESWT machine profitable.

Re: I think they have got the numbers

Pauline on 12/10/01 at 22:58 (066680)

These two large medical centers purchased almost all of the smaller hospitals in our area and have built at least 20 satellite buildings also housing large Orthopedic staffs. At the campus I visit there must be at least 20 Orthopedic physicians on staff not counting residents etc. The numbers vary but I think they have the numbers on staff right now to make money pretty easily. If they get insurance coverage they are home free.
One center treats 3 professional sport teams. They come for everything
pre season checks, mid season checks, after season checks any kind of checks. They get treatments just in case something might go wrong. They must have huge files for the teams themselves. Then there are their families. I saw Joe Dumars and his mother in for their checks. Nicest people you would ever want to meet. I asked him for his autograph and got him mom's too. Now how many people have Joe Dumars mother's autograph. Joe still looks like kid, wearing his base ball cap backward and carring a back pack. His hugh shoes gave him away. He is very easy to talk to and he laughed when I told him his mother made him what he is today. His mom smiled. I love the set up they have at their Center for Sports Medicine.

Re: I think they have got the numbers

RACHAEL T. on 12/10/01 at 23:09 (066681)

I assume you must be from Michigan - Detroit? Cause I think Joe Dumars plays for Pistons?? Is that correct location of where you are?

Re: I think they have got the numbers

Dr. Zuckerman on 12/11/01 at 10:48 (066707)

I am not from Detroit but he had alot to do with a championship in Detroit. He is one great Basketball player. I think he played with Dennis Rodman before Dennis decided to look and act like Madonna and play for the Bulls

Re: GREAT !!!!!!!

BrianG on 12/02/01 at 18:23 (065933)

This sounds GREAT to me. So, now we have 2 machines in the US approved for treating PF, the Ossatron and the Dornier. Do you happen to know if it was the Epos Ultra machine? This is the one that had trials in Boston, Atlanta, Detriot, Canada and Germany a couple years ago. Now, if only the insurance companies come on board also!!!!

This is progerss, slow but sure.

BCG

Re: GREAT !!!!!!!

DR Zuckerman on 12/02/01 at 19:03 (065935)

It was the epos. Only time will time, how great class three classification
approval will be, and the cost of the treatment is the only thing that will bring insurance on board. Will inform this board when I I know details that I can vertify.

Re: GREAT !!!!!!!

Pauline on 12/02/01 at 19:54 (065937)

Brian,
This is the one you were waiting for and the one sitting in my Orthos office. The big guys have this one so it will be interesting to see if they get the insurance coverage now. I think it will take a while, but it will come. I know my doc is waiting to use it on some sports figures because he treats several teams here. Of course they (the
teams) can cover their costs pretty well.

I can't see them turning down places like Mass General, U of M. UCLA, Henry Ford, Emory. They do the big kidney stuff so if they are already using Dornier for I think they will push for this new Dornier to be covered too.

It's a waiting game now. These hospitals can't afford to have Dornier's machine just sitting in their centers with no money coming in collecting dust. I personally think they will lead the way for insurance coverage. That would be wonderful for many PF sufferers.

Re: GREAT !!!!!!!

BrianG on 12/02/01 at 21:11 (065948)

I went to the FDA site, but couldn't find anything. Maybe it will take a few days for it (the site) to be updated? Mass General was in on the last trials. I called, but was too late. They, MGH, probably had enough of their own PF patients to fill the study.

Outside of a miracle, this is my last chance.
BCG

Re: GREAT !!!!!!!

DR Zuckerman on 12/02/01 at 21:23 (065950)

Lets hope they keep it out of the surgical centers and into the office. Now that would keep the cost down and maybe bring in the insurance companies.

Most of the big insurance companies want long term outcome studies not FDA trials. This can take years

Re: For Dr Z: Maybe, maybe not !

BrianG on 12/05/01 at 22:35 (066287)

Hi Dr Z,

Could you please check your sources for the Dornier. I contacted someone from the FDA, and they are not aware of it being approved.

Thanks
BCG

Re: For Dr Z: Maybe, maybe not !

DR Zuckerman on 12/05/01 at 23:03 (066292)

It isn't finalized but they are going to get it within the next few weeks.
The final labeling process isn't done

Re: GREAT !!!!!!!

Pauline on 12/10/01 at 20:31 (066670)

Well it sure took long enough. I've been petting that machine for over
18 months and now I don't need it. But at least I know it's ready to go when my next PF case appears.

Brian, sounds like your on your way to Mass General when and if insurance coverage comes through. I hope it does the trick for you so you can close this chapter in you life and move on to one pain free.

I'll try calling my doctors office to see if they are getting insurance coverage after the first of the year. I don't know if he has used it on anyone yet since I haven't been back to see him.

Dr. Z if they keep the machine in these hospital medical centers would physicians have to be on staff to use it or would it be open to any physician?

Re: GREAT !!!!!!!

DR Zuckerman on 12/10/01 at 21:48 (066675)

I would have to say yes to the on staff question. That is the way it worked for the ossatron at the Healthsouth surgical center that I belong to in my area. It would be wise to re-consider that position . It takes a lot of doctors to make the ESWT machine profitable.

Re: I think they have got the numbers

Pauline on 12/10/01 at 22:58 (066680)

These two large medical centers purchased almost all of the smaller hospitals in our area and have built at least 20 satellite buildings also housing large Orthopedic staffs. At the campus I visit there must be at least 20 Orthopedic physicians on staff not counting residents etc. The numbers vary but I think they have the numbers on staff right now to make money pretty easily. If they get insurance coverage they are home free.
One center treats 3 professional sport teams. They come for everything
pre season checks, mid season checks, after season checks any kind of checks. They get treatments just in case something might go wrong. They must have huge files for the teams themselves. Then there are their families. I saw Joe Dumars and his mother in for their checks. Nicest people you would ever want to meet. I asked him for his autograph and got him mom's too. Now how many people have Joe Dumars mother's autograph. Joe still looks like kid, wearing his base ball cap backward and carring a back pack. His hugh shoes gave him away. He is very easy to talk to and he laughed when I told him his mother made him what he is today. His mom smiled. I love the set up they have at their Center for Sports Medicine.

Re: I think they have got the numbers

RACHAEL T. on 12/10/01 at 23:09 (066681)

I assume you must be from Michigan - Detroit? Cause I think Joe Dumars plays for Pistons?? Is that correct location of where you are?

Re: I think they have got the numbers

Dr. Zuckerman on 12/11/01 at 10:48 (066707)

I am not from Detroit but he had alot to do with a championship in Detroit. He is one great Basketball player. I think he played with Dennis Rodman before Dennis decided to look and act like Madonna and play for the Bulls