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.
You may also be interested in...
Medtronic’s Renal Denervation System Will Get Parallel Treatment From FDA And CMS
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
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.
St. Jude Plans Trial To Study Renal Denervation Outcomes
Landmark trial will evaluate whether reductions in blood pressure caused by renal denervation translate to clinical improvements in patients with hard-to-treat hypertension.