CE mark for new Symplicity system


Medtronic has announced that it has received both CE-mark approval and Australian therapeutic goods administration (TGA) listing for a new Symplicity renal denervation system, consisting of a flexible 4 French multielectrode catheter (Symplicity Spyral) and a radio frequency generator (Symplicity G3). The company reports that the new system is designed to significantly reduce ablation time and provide ease of deliverability during renal denervation procedures for patients with uncontrolled hypertension.

According to a press release, the Spyral catheter features four electrodes that are able to deliver simultaneous or selective radiofrequency energy into the renal artery wall to disrupt the output of overactive sympathetic nerves. It is compatible with a 6 French guide catheter and is delivered over a 0.014 inch guidewire via a rapid exchange system.

The press release adds that the catheter is powered by the new G3 radiofrequency generator, which it says leverages the benefits of Medtronic’s proprietary Symplicity treatment algorithm with its built-in safety features. The system uniquely offers physicians control and flexibility with the ability to turn specific electrodes on and off to accommodate different anatomies. The G3 generator includes a new touch screen user interface compatible with the single-electrode Symplicity catheter.

“The multielectrode Symplicity system builds upon the single-electrode Symplicity system by helping significantly reduce ablation time,” said Michael Böhm, chairman, Department of Internal Medicine, University of Saarland, Homburg/Saar, Germany. “Further, the ease of use and exceptional deliverability help simplify the procedure.”