SHC 0.00% 2.5¢ sunshine heart, inc.

minnetronix development deal, page-7

  1. 3,312 Posts.
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    they discussed changes that dont affect the way the device operates. They discussed this in terms of minor software upgrades and in terms of an extra inch of cord sticking out of the body at the exit site.

    I believe that changing the entire way the battery pack works would be a major change to the device itself and they would probably end up having to do a completely new study. Hopefully I'm wrong and the FDA allows for this to be incorporated. With a fully implantable, the most common side effect (exit site infection) would be completely removed, as there would be no exit site. This could only improve the results.

    Also, the device would look a lot more attractive to patients if they didnt need to have cord sticking out their body.
 
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