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Medtronic receives FDA nod for Symplicity Catheter System clinical trial

Medtronic has received the US Food and Drug Administration (FDA) approval to initiate SYMPLICITY HTN-3 clinical trial of renal denervation with the Symplicity Catheter System to treat resistant hypertension.

SYMPLICITY HTN-3 is a controlled, randomized, single-blind trial designed to evaluate the safety and effectiveness of renal denervation with the Symplicity Catheter System.

The Symplicity Catheter System consists of a proprietary generator and a flexible catheter which is introduced through the femoral artery in the upper thigh and is threaded up into the renal artery near each kidney.

The tip delivers low-power radio-frequency (RF) energy according to a proprietary algorithm, or pattern, to modulate the surrounding sympathetic nerves.

The study will enroll 500 patients who will be randomized to receive either renal denervation and treatment with anti-hypertensive medications or treatment with anti-hypertensive medications alone.

The primary endpoints of the study are the change in blood pressure from baseline to six months following randomization and incidence of major adverse events one month following randomization.