Medtronic’s Renal Denervation System Will Get Parallel Treatment From FDA And CMS
This article was originally published in The Pink Sheet Daily
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.
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Exact Sciences, one of the first companies to volunteer for a pilot program launched in 2011 testing FDA-CMS parallel review, says its experience with the process so far is very positive. Agency officials are planning to review experiences with the program to make improvements.
Landmark trial will evaluate if reductions in blood pressure caused by renal denervation translate to clinical improvements in patients with hard-to-treat hypertension.
Deal gives Boston Scientific access to the V2 radiofrequency energy-based renal denervation catheter system for drug-resistant hypertension.