Medtronic’s Renal Denervation System Will Get Parallel Treatment From FDA And CMS
This article was originally published in The Gray Sheet
Executive Summary
The device is one of 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.
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Renal Denervation Downer: Medtronic’s Pivotal Trial Misses Efficacy Endpoint
The firm’s SYMPLICITY HTN-3 trial failed to meet its primary efficacy endpoint, scuttling Medtronic’s plans to earn a PMA for renal denervation this year. The primary investigator for the trial acknowledges in an interview that the finding raises serious questions for the future of renal denervation in hypertension.
Renal Denervation Downer: Medtronic’s Pivotal Trial Misses Efficacy Endpoint
The firm’s SYMPLICITY HTN-3 trial failed to meet its primary efficacy endpoint, scuttling Medtronic’s plans to earn a PMA for renal denervation this year. The primary investigator for the trial acknowledges in an interview that the finding raises serious questions for the future of renal denervation in hypertension.
CDRH Preps New Program To Streamline Approval-To-Reimbursement Path
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