Medtronic's Symplicity Spyral Multielectrode Catheter and Symplicity G3 Generator Approved in Europe and Australia

December 5, 2013—Medtronic, Inc. (Minneapolis, MN) announced European CE Mark and Australian Therapeutic Goods Administration listing for the company's highly flexible, 4-F multielectrode Symplicity Spyral catheter and Symplicity G3 radiofrequency (RF) generator.

According to the company, the new system is designed to significantly reduce ablation time and provide ease of deliverability during renal denervation procedures for patients with uncontrolled hypertension. The system offers physicians control and flexibility with the ability to turn specific electrodes on and off to accommodate different anatomies.

The multielectrode Spyral system is powered by a new RF generator that leverages Medtronic's Symplicity treatment algorithm with built-in safety features and the Symplicity helical ablation pattern. The G3 generator includes a new touchscreen user interface compatible with the single-electrode Symplicity catheter. The Symplicity renal denervation system is available for investigational use only in the United States, advised Medtronic.

The Symplicity Spyral catheter features four electrodes that are able to deliver simultaneous or selective RF energy into the renal artery wall to disrupt the output of overactive sympathetic nerves. The new 4-F catheter is compatible with a 6-F guide catheter and is delivered over a 0.014-inch guidewire via a rapid exchange system. The Symplicity Spyral catheter is highly conformable to artery shape and size and accommodates vessel diameters of 3–8 mm. Its nonocclusive design ensures the catheter will not obstruct renal blood flow during the procedure.

In Medtronic's press release, Michael Böhm, MD, who is Chairman of the Department of Internal Medicine at University of Saarland in Homburg/Saar, Germany, commented on the new system. Dr. Böhm stated, “The multielectrode Symplicity system builds upon the single-electrode Symplicity system by helping significantly reduce ablation time. Further, the ease of use and exceptional deliverability help simplify the procedure.”