Friday, January 10, 2014


Medtronic International, the maker of the Symplicity catheter for Renal Denervation ( RDN ), has just announced that the preliminary results of Symplicity - HTN 3 failed to achieve its primary endpoint.
Symplicity - HTN 3 is probably the largest RDN trial to date that has a sham arm, to try and exclude the placebo part of the procedure. The study population of 535 strong ( a large enough number ), underwent RDN and there was a control arm and these patients underwent a sham operation. The primary endpoint was office reduction of blood pressure, and well as a reduction in major adverse events at 1 - 6 months. Medtronic announced that early review of the data showed that there was no significant reduction in the major adverse events, although there were no safety concerns. Dr G Bakris ( U of Chicago ) and Dr Deepak Bhatt ( Brigham and Women Hospital, Boston ) said that they will be reviewing the large amount od data, before publishing the results.
Looks like all is not so well with Renal Denervation ( RDN ) and Symplicity - HTN 3.

I do not have all the data, so we need to take a closer look and see what happened and where was the shortcoming.
Do we need a Symlicity - HTN 4?
There are at least 4 other companies with catheters ready for marketing ( some are already slightly in the market ).

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