Big Announcement Soon

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Anonymous said:
Quote (http://pubs.acs.org/doi/pdf/10.1021/ma301965y):

Of course, we recognize that these two commercial
polyurethanes are used in implantable biomedical devices that
must endure long-term exposure to physiological conditions. In
such aqueous and oxidative environments, degradation of molar
mass in such elastomers should be of principal concern when
evaluating and predicting long-term performance characteristics.
Our work here suggests that the mechanical integrity of
these PDMS-based PEUs may be compromised in such
applications (e.g., as insulation on pacemaker/defibrillator
leads) as a result of simple hydrolysis of the segmented
polyurethane macromolecules. Thus, while the oxidative
stability of these PDMS-containing elastomeric polyurethanes
is enhanced and the level of water uptake is reduced, our results
suggest that the hydrolytic cleavage of these polymers is not
eliminated and raises cause for concern in long-term
implantable biomedical devices.

Oops................................. Durata
Click to expand...


Just Durata? I thought ALL stj leads were Optim...
 






Anonymous said:
Quote (http://pubs.acs.org/doi/pdf/10.1021/ma301965y):

Of course, we recognize that these two commercial
polyurethanes are used in implantable biomedical devices that
must endure long-term exposure to physiological conditions. In
such aqueous and oxidative environments, degradation of molar
mass in such elastomers should be of principal concern when
evaluating and predicting long-term performance characteristics.
Our work here suggests that the mechanical integrity of
these PDMS-based PEUs may be compromised in such
applications (e.g., as insulation on pacemaker/defibrillator
leads) as a result of simple hydrolysis of the segmented
polyurethane macromolecules. Thus, while the oxidative
stability of these PDMS-containing elastomeric polyurethanes
is enhanced and the level of water uptake is reduced, our results
suggest that the hydrolytic cleavage of these polymers is not
eliminated and raises cause for concern in long-term
implantable biomedical devices.

Oops................................. Durata
Click to expand...

Don't forget:
"For simple chemical reactions that follow Arrhenius rate dependencies, the correlation between reaction rate and temperature is well established for myriad reactions (citation)."

Arrhenius: http://en.wikipedia.org/wiki/Arrhenius_equation
Myriad (adj): "having innumerable aspects or elements"
 






Anonymous said:
Quote (http://pubs.acs.org/doi/pdf/10.1021/ma301965y):

Of course, we recognize that these two commercial
polyurethanes are used in implantable biomedical devices that
must endure long-term exposure to physiological conditions. In
such aqueous and oxidative environments, degradation of molar
mass in such elastomers should be of principal concern when
evaluating and predicting long-term performance characteristics.
Our work here suggests that the mechanical integrity of
these PDMS-based PEUs may be compromised in such
applications (e.g., as insulation on pacemaker/defibrillator
leads) as a result of simple hydrolysis of the segmented
polyurethane macromolecules. Thus, while the oxidative
stability of these PDMS-containing elastomeric polyurethanes
is enhanced and the level of water uptake is reduced, our results
suggest that the hydrolytic cleavage of these polymers is not
eliminated and raises cause for concern in long-term
implantable biomedical devices.

Oops................................. Durata
Click to expand...

Good thing that Optim only comprises .003 inch thickness of the lead.
Now the real problem is actually inside-out abrasion -something totally independant of Optim.
 






Anonymous said:
Good thing that Optim only comprises .003 inch thickness of the lead.
Now the real problem is actually inside-out abrasion -something totally independant of Optim.
Click to expand...

I don't believe that's true of the brady and heart failure leads. I'm thinking those leads are made mostly of optim. Can anyone confirm or deny this?
 






























All current low voltage Brady leads are fully Optim insulated (Tendril and Optisense). That is the outer insulation around outer coil is Optim only. However, the inner insulation between inner and outer coil is still silicone.
 












Anonymous said:
I can neither confirm nor deny, but I think STJ kinda suspected hydrolysis, so they didn't allow it to be a major structural part of any lead.
Click to expand...

that's just stupid and uninformed. There's no way that STJ would have suspected hydrolysis unless they had done testing to indicate it. if they had done testing there's no way they would have put this on their lead. The conclusion of your argument, 'therefore they didn't allow it to be a major structural part of any lead,' is also false.

Medtronic, however, did do material testing. I bet you that they did this testing before St. Jude started working with the material. My guess is that they did an animal study many years ago, it failed, and they did this testing to determine why it failed. They're just publishing a paper and releasing the data to stick it to STJ.

It's possible that Aortech made changes based on the results of MDT's testing (if ti came before they started selling to STJ) if MDT did the testing as part of a material selection process. I doubt that, but if they did, STJ will be releasing a press release I am sure.
 












1) Stj publicly has claimed that inside out abrasions will be prevented by Optim.
2) there have been case studies showing optim break down
3) every lead stj sells today excluding durata is made entirely of optim. A fact that untill this week stj reps were very proud to admit.
4) accelerated testing of these leads to show their bio stability is an industry standard.
5) every one keeps saying that if there was a problem stj would have known about it. Don't u think that if stj were able to do good bench testing they would have never have released Riata, Riata st, quick flex?

Fact: stj has had a continuos series of lead failures. They have no quality department. They grew tachy market share from 5-25% since 2003 because they were willing to put profits ahead of patients over and over again.
Opinion: they have no choice but to continue to pretend to be other than what they are. They have no back up plan!
 


















Quartet. Distal cable has no redundant insulation.
Point 3 did not account for the fact that stj reps might believe that the etfe coating around cables is enough. I forgot that they have made the worlds first 2 fr lead conductor only.
 






Anonymous said:
Quartet. Distal cable has no redundant insulation.
Point 3 did not account for the fact that stj reps might believe that the etfe coating around cables is enough. I forgot that they have made the worlds first 2 fr lead conductor only.
Click to expand...

Well if there is only Optim (no silicone) on the distal portion of the Quartet, then why aren't we seeing any hydrolysis on that part of the Quartet?
 












Anonymous said:
What Starks knows and failed to reveal is that STJ engineers failed to prove to the FDA the material difference in lead design between Riata and Durata. This failure results in the FDA shutting down the release of future STJ products, including the continuation of selling Durata until measurable and proven enhancements have been made. FDA's view is that allowing a product, that does not significantly differ from a Recalled product should not be sold to the public and represents a health and safety hazard. STJ simply could not prove to the FDA a material difference between the 2 leads.
Click to expand...

Well, I'm back! Looking back on my thread over a month ago...it's a bit haunting and to those doubters, how far off am I? You do realize the next move by the FDA, and this will happen, is that STJ will be issued a letter that they will not be allowed to release any products over the next 2 years. Oh yeah,,,and this Durata issue will be forced down STJ's throat...RECALL cometh!!!!!

See you next month for another "Told ya so!!!"
 






Anonymous said:
Well, I'm back! Looking back on my thread over a month ago...it's a bit haunting and to those doubters, how far off am I? You do realize the next move by the FDA, and this will happen, is that STJ will be issued a letter that they will not be allowed to release any products over the next 2 years. Oh yeah,,,and this Durata issue will be forced down STJ's throat...RECALL cometh!!!!!

See you next month for another "Told ya so!!!"
Click to expand...

U speak the truth. This could very well take down their entire lead portfolio. This will surpass anything a med device company has ever faced and its 100% their fault. Sound as if the FDA is considering mdt's work in optim and calling stj out for not properly vetting optim.
 






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