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

 
• By Reed Miller

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.

FDA and CMS have agreed to review Medtronic PLC’s Symplicity renal denervation hypertension treatment system concurrently as part of the agencies’ parallel review pilot program, the company announced March 6.

The device is one the first, and perhaps the most high profile, to participate in the program, in which CMS...

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