Health Canada has granted license to Medtronic's Symplicity Renal Denervation system used to reduce treatment-resistant high blood pressure in patients unresponsive to three or more anti-hypertensive medications.
The Symplicity system comprises a 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 of the catheter delivers low-power radio-frequency energy according to a proprietary algorithm, or pattern, to ablate the surrounding sympathetic nerves.
Results from the Symplicity HTN-1 trial has shown safety and effectiveness of renal denervation with the Symplicity Renal Denervation system out to three years.
The Symplicity HTN-2 trial results showed safe, and statistical reduction of blood pressure (-33 mg Hg systolic blood pressure) at six months following the procedure and sustained to 12 months.
Medtronic said the Symplicity Renal Denervation system has received CE mark and Australia’s Therapeutic Goods Administration (TGA) approval.
The Symplicity Renal Denervation system is under investigational use in the US.
Peter Munk Cardiac Centre medical director Barry Rubin said decreasing a patient’s systolic blood pressure from 160 to 130 mm Hg over a period of six months, which renal denervation has been shown to do, could prevent many heart attacks and strokes from ever happening.
"Our multidisciplinary renal denervation program, which includes interventional radiologists, vascular surgeons, cardiologists, hypertension and kidney specialists will treat many eligible patients in the months ahead," Rubin added.