NxStage in Ontario

[ciscochampion]

Hi, I'm new to the group and sorry if this topic has already been raised. I'm trying to find out if the NxStage Hemo machine is currently in Ontario. I know it's very popular in the USA. I am go a mission to try and bring this to Ontario...

Thanks,
Phil

[sunshine]

(06-14-2009 06:01 PM)ciscochampion Wrote:  Hi, I'm new to the group and sorry if this topic has already been raised. I'm trying to find out if the NxStage Hemo machine is currently in Ontario. I know it's very popular in the USA. I am go a mission to try and bring this to Ontario...

Thanks,
Phil

Hello ciscochampion Welome!

From what I have heard, NxStage has been approved for use
in Canada, but Canada has not approved it as of yet.
I'll try to dig out more info.

[Jester]

Well Champ....Here's a start for you....

Hello. My name is Jeff Smith. I work as General Manager for the Home Therapy Business at NxStage Medical in the U.S. Richard asked me to qualify information on NxStage and plans for Canada. His request was a follow up to our recent announcement regarding our recent distribution agreement for the UK.
NxStage is very interested in making our product available in Canada. Unfortunately the Canadian regulatory requirements differ from the US and the UK. In the US our dialysate solutions (whether premixed in 5 L bags or batch manufactured in the home using our PureFlow system) are considered "medical devices". In Canada they are consider drugs. The information to support a drug filing in Canada is significantly more than what is required to obtain clearance of a medical device. We are working on collecting the additional information to support the Canadian filing. I would like to provide an estimated time but the regulatory approval process introduces uncertainly and any date provided would be wrong.
We believe our product will be very well suited to the Canadian market. Home Hemo is more developed and appears to have good support from the government and physicians.
If anyone is looking for additional information please feel free to contact me via email at jlsmith@nxstage.com.

http://www.facebook.com/home.php#/topic....topic=9838

My name is Richard and from Sudbury Ontario...my e-mail add is in my profile...and at Canadian Kidney Connection on Facebook

[ciscochampion]

Hello Jeff, thanks for the reply. It seems to me that the Canadian relulatory dept needs to understand the dialysate solution is not considered a drug, but an aid to a medical device. My understanding is that a 'drug' is something which is consumed. If this is the only stumbling block, I am sure that it will be overcome. I am also going to write to my MPP and get this project underway...it's time for Canadians to see the benefit of the nxstage system...

Phil


If anyone is looking for additional information please feel free to contact me via email at jlsmith@nxstage.com.

http://www.facebook.com/home.php#/topic....topic=9838

My name is Richard and from Sudbury Ontario...my e-mail add is in my profile...and at Canadian Kidney Connection on Facebook
[/quote]

[Jester]

You do that Phil write your MPP.

Christine Elliott Whitby--Oshawa
Queen's Park
Room 445,
Main Legislative Building, Queen's Park
Toronto, Ontario M7A 1A8
Tel 416-325-1331
Fax 416-325-1423
christine.elliott@pc.ola.org
Constituency Suite 101
114 Dundas Street East
Whitby, Ontario L1N 2H7
Tel 905-430-1141
Fax 905-430-1840
christine.elliottco@pc.ola.org

You can also tell her husband her husband Jim Flaherty our Federal Minister of Finance to talk to the Federal Minister of Health of Canada

[newfiegirl]

Hopefully if nx stage becomes available in Canada it will be available in other provinces as well. We would LOVE to have a portable machine.

[M3Riddler]

I reallly hope NxStage makes it to Canada. It has changed the lives of many and has provided Dialysis Patients with a Choice.
Hopefully Canada will accept NxStage and bring it to your country. It has changed the lives and given many the Independence they would not have otherwise.....

///M3R

[sunshine]

Once Canada wakes up and see's the advantages NxStage has to
offer to patients in other countries, hopefully we will then have the
option to choose one of the most practical method of treatment too.


SS

[belle_starr]

YOU GUYS R SO GOOD

[angieskidney]

Ah yes I was going to quote Jeff Smith's email to me on here but I see you already beat me to it

Hopefully NxStage will come to Canada eventually because the interest is there on BOTH sides of the border.

The thing is .. before bringing NxStage to Canada the regulation on how meds are seen need to be changed so that the dialysis fluid isn't seen as a drug. I remember when I was on Peritoneal Dialysis each dialysis bag had a DIN (Drug ID number I believe it stands for) on them.

(06-15-2009 03:57 AM)Jester Wrote:  Well Champ....Here's a start for you....

Hello. My name is Jeff Smith. I work as General Manager for the Home Therapy Business at NxStage Medical in the U.S. Richard asked me to qualify information on NxStage and plans for Canada. His request was a follow up to our recent announcement regarding our recent distribution agreement for the UK.
NxStage is very interested in making our product available in Canada. Unfortunately the Canadian regulatory requirements differ from the US and the UK. In the US our dialysate solutions (whether premixed in 5 L bags or batch manufactured in the home using our PureFlow system) are considered "medical devices". In Canada they are consider drugs. The information to support a drug filing in Canada is significantly more than what is required to obtain clearance of a medical device. We are working on collecting the additional information to support the Canadian filing. I would like to provide an estimated time but the regulatory approval process introduces uncertainly and any date provided would be wrong.
We believe our product will be very well suited to the Canadian market. Home Hemo is more developed and appears to have good support from the government and physicians.
If anyone is looking for additional information please feel free to contact me via email at jlsmith@nxstage.com.

http://www.facebook.com/home.php#/topic....topic=9838

My name is Richard and from Sudbury Ontario...my e-mail add is in my profile...and at Canadian Kidney Connection on Facebook