Why Were These Mechanisms Not Discovered Before Market Release

5 Why Were These Mechanisms Not Discovered Before Market Release  

We were criticized for not discovering subclavian crash in animal experiments. A plaintiff s expert claimed that if we had implanted 500 dogs for 3 years prior to clinical use, it would have been obvious. The expert making this claim, however, did not apparently realize that dogs, cats, sheep, etc., do not have clavicles, so detection of subclavian crash would be impossible in animal tests, no matter how many were used. 

We were also criticized for implanting materials, but not devices for 2 years prior to clinical use. In fact, it seemed quite reasonable at that time that a biocompatible and biostable material would make a biocompatible and biostable lead. In fact, we now know that even 2-5-year implants of devices in canines may or may not necessarily produce measurable ESC or MIO (depending on the lead model). Nonetheless, lead failure due to ESC, MIO, and crash in humans was reported in 

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