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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

The device center is in the very early stages of launching the “CDRH Reimbursement Program,” planning to go beyond its current parallel-review collaboration with CMS to work with device firms, CMS and private payers to streamline the pathway from market approval to reimbursement.

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