After paying $800M for Ardian and spending way more in US clinical trials, when will this procedure be FDA approved? Is it making any money OUS. Since it appears no more effective than or-l generic dr-gs (last US pivotal) will insurance companies cover it?
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Medtronic invested in RDN for 15+ years with a series of failures with the clinical studies. First major pivotal study failed to deliver on primary and secondary end points, 9 years back. All other companies which were pursuing Renal Denervation bolted with this epic failure!
Medtronic kept investing more millions $ with revised clinical study objectives and the results were announced last year with another gigantic miss on the primary end points on performance.
All in all, the great promise of ‘Cure for Hypertension’ was fake as the leadership promise of turning the new leaf and panacea of MIP!
Don’t base your future on the failed product called Renal Denervation!
It didn’t meet its efficacy goal. It has to go to panel. Even with approval reimbursement will be tough . It’s a tu-d.
Well this year will be the key. I think FDA will eventually approve it. It's a question of adoption by the market and how patients see it.