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Anonymous said:
This study says it breaks down at boiling water temperature. Duh! Not what I'd call a good simulation of vascular conditions.
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Aortech's patent calls Elasteon a biostable material... so it shouldn't degrade in any appreciable way in the body... otherwise you shouldn't call it biostable.
http://www.google.com/patents/EP2001923A1?cl=en

I haven't actually seen the study yet but the use of elevated temperature is common and sound way to perform stability testing and help to establish a shelf life. If the failure mechanism doesn't have anything to do with melting then the elevated temperatures will just serve to accelerate testing so that you can get to your end result quicker. The heat just accelerates the natural course of events by speeding up the molecular movement. Equating the time to failure in the testing to a time to failure under normal conditions is the tricky part.

100 C would not be unreasonable for this sort of testing.
 






Anonymous said:
This study says it breaks down at boiling water temperature. Duh! Not what I'd call a good simulation of vascular conditions.
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polyurethane and silicone do not break down at 100 C. (They do stretch more though). silicone's good to a couple hundred degrees C... polyurethanes tend to melt around 200 deg C
 












Anonymous said:
Aortech's patent calls Elasteon a biostable material... so it shouldn't degrade in any appreciable way in the body... otherwise you shouldn't call it biostable.
http://www.google.com/patents/EP2001923A1?cl=en
I haven't actually seen the study yet but the use of elevated temperature is common and sound way to perform stability testing and help to establish a shelf life. If the failure mechanism doesn't have anything to do with melting then the elevated temperatures will just serve to accelerate testing so that you can get to your end result quicker. The heat just accelerates the natural course of events by speeding up the molecular movement. Equating the time to failure in the testing to a time to failure under normal conditions is the tricky part.

100 C would not be unreasonable for this sort of testing.
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You are confused between shelf stability testing and the biostability testing that this study TRIES to address. I'm not going to go into the scientific details here, but 100 C is EXTREMELY unreasonable for testing biostability of a plastic which melts. Try to separate the BS from the science here.
 






We will just have to wait and see what is more credible, a peer reviewed paper in very credible journal or a bunch of hack posters (including me) on CafePharma. Here is what I know.I have been at Guidant / Boston for over 10 years. I lost a ton of business with the recalls 7 years ago. St. Jude reps were arrogant, nasty, and dishonest in how they took advantage of the situation. I always know there time would come. I stayed through all the tough times (thanks TG, MB, JR and others for the generous EA). I believe my decision will pay off. One of my customers who stopped using me in 2007 has come back slowly over the years. He was wined and dined by St. Jude and offered tons of "research," to do business with them. He has become more and more skeptical about Riata/Durata. A few weeks ago, he was at a meeting with some other doctors he has a lot of respect for and heard all about this paper coming on Optim. He has stopped using St. Jude since then and told me this is very real and will destroy St. Jude. I don't know the science well enough to tell the difference between all the testing variables, but my customer said they heard all the stuff St. Jude will come back with that shows why this is wrong. Again, I can't explain, but he said the science is very good and credible and St. Jude will try to deny this and muddy the waters -------gee, I can't picture that. He explained to me why there response is BS. He also told me that he plans on using a lot of SubQ devices once it is available. Scott O, please do not let any of these aholes who ran to st jude come crawling back now. They sold their soles. Screw em!
 






Yep, St Jude benefitted from our demise at Guidant in an arrogant way. Good luck whereever you are. As for the sub Q, it's a niche product right now. Infection rate during clinicals was 5.8% and that's with "good" implanters. Usual for an ICD implant is 0.7%. Longevity is 5 years versus 8-10 years for most others. We will see.
 






Anonymous said:
We will just have to wait and see what is more credible, a peer reviewed paper in very credible journal or a bunch of hack posters (including me) on CafePharma. Here is what I know.I have been at Guidant / Boston for over 10 years. I lost a ton of business with the recalls 7 years ago. St. Jude reps were arrogant, nasty, and dishonest in how they took advantage of the situation. I always know there time would come. I stayed through all the tough times (thanks TG, MB, JR and others for the generous EA). I believe my decision will pay off. One of my customers who stopped using me in 2007 has come back slowly over the years. He was wined and dined by St. Jude and offered tons of "research," to do business with them. He has become more and more skeptical about Riata/Durata. A few weeks ago, he was at a meeting with some other doctors he has a lot of respect for and heard all about this paper coming on Optim. He has stopped using St. Jude since then and told me this is very real and will destroy St. Jude. I don't know the science well enough to tell the difference between all the testing variables, but my customer said they heard all the stuff St. Jude will come back with that shows why this is wrong. Again, I can't explain, but he said the science is very good and credible and St. Jude will try to deny this and muddy the waters -------gee, I can't picture that. He explained to me why there response is BS. He also told me that he plans on using a lot of SubQ devices once it is available. Scott O, please do not let any of these aholes who ran to st jude come crawling back now. They sold their soles. Screw em!
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You are one of the more straight-forward posters here. Thanks for telling what you know and what you don't know. Probably the 100 C temperature came up from a STJ guy as a diversion.
When you do hear where the report will appear, please let us know.
 






Anonymous said:
He also told me that he plans on using a lot of SubQ devices once it is available. Scott O, please do not let any of these aholes who ran to st jude come crawling back now. They sold their soles. Screw em!
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It's so hard to understand why people would use the SubQ defib --- is it just worried patients? I just could never see how I'd could recommend it.
 






Elevated temperature testing is a commonly accepted practice in evaluating materials to provide accelerated life data. What I expect to see, based on what I have heard, is that the STJ material falls off much faster than other currently used materials in the same test setup. Since the industry has long term (10+ year) data on other silicone and polyurethane the model can be validated against that experience. When the co-polymer starts falling apart and - oh by the way it happens to mirror the problems seen in the field with the inner coils moving around as inner insulation degrades - it's hard to wave your hands and say "no problem, nothing to see here, keep moving".
 












Anonymous said:
Elevated temperature testing is a commonly accepted practice in evaluating materials to provide accelerated life data. What I expect to see, based on what I have heard, is that the STJ material falls off much faster than other currently used materials in the same test setup. . . ..
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You are using the wrong test to evaluate biostability. The elevated temperature test applies to shelf stability. Of course a plastic (as Optim is) is going to be softer at an elevated temperature, and degrade. But that doesn't simulate vascular conditions.
 






I think the prior poster is correct. Assuming the material is tested at an elevated temp is in a saline bath, a body fluid standard, the accelerated testing will bring on the hydrolysis reaction faster.

This is a good model for in vivo and it can simulate the chemical reactions the material is subjected to. Shelf life is not the issue. Also I hope there is comparative data on current materials so if Optim diverges from the others it is obvious.
 






Anonymous said:
It's so hard to understand why people would use the SubQ defib --- is it just worried patients? I just could never see how I'd could recommend it.
Click to expand...

If you had a failed fidelis/Riata/Durata you'd think differently. There are pts that refused endovascular implant that want this device. Also can you imagine if this had been around 7 or so years ago? Thousands of patients wouldn't be dealing with or wouldn't have dealt w these lead issues. that's just a couple of reasons. Once the next gen is released the acceptance will be even greater.
 




































Anonymous said:
This is a good model for in vivo and it can simulate the chemical reactions the material is subjected to. . . .. Also I hope there is comparative data on current materials so if Optim diverges from the others it is obvious.
Click to expand...


The problem with your judgement of this as a good model, is that the non-technical take it out of context. They look at the absolute rate of hydrolysis at the high temperature and think that the same thing will happen at body temperature. Not so.
You do have it right that it should be compared to the data on current materials AT THE SAME TEMPERATURE.
 






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