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With Trial Approval, Medtronic Aims For Symplicity RF Catheter Launch In 2014

This article was originally published in The Gray Sheet

Executive Summary

With conditional FDA approval for its pivotal trial in hand, Medtronic says it is on track to launch its Symplicity renal nerve ablation catheter system for drug-resistant hypertension in the U.S. in 2014.

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The device is one the first, and perhaps the most high profile, to participate in the budding parallel review program, in which CMS can begin considering a national Medicare coverage policy for a new technology as FDA is reviewing its safety and efficacy for regulatory approval.

Medtronic’s Renal Denervation System Will Get Parallel Treatment From FDA And CMS

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