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Medtronic announced Thursday that its Symplicity Spyral catheter and Symplicity G3 radio frequency (RF) generator received the CE mark and Australia's Therapeutic Goods Administration listing. The company said the system is designed to "significantly reduce ablation time and provide ease of deliverability during renal denervation procedures" in uncontrolled hypertension.
According to Medtronic, the new multi-electrode Spyral system is built upon the clinical success and safety profile of the single-electrode Symplicity renal denervation system. The device maker noted that the flexible 4 Fr multi-electrode system leverages the Symplicity treatment algorithm and helical ablation pattern of the single-electrode Symplicity renal denervation system. The catheter accommodates vessel diameters of three to eight millimetres and features four electrodes that are able to deliver simultaneous or selective RF energy into the renal artery wall to disrupt overactive sympathetic nerve output. The RF generator, which includes a new touch screen user interface, offers physicians the ability to turn specific electrodes on and off to accommodate different anatomies, Medtronic added.
Medtronic noted that the clinical evaluation programme of the system will involve more than 8000 patients globally, including the US, where the FDA recently approved the start of clinical studies, Europe and Japan, with more than 1200 of these patients participating in randomised trials. The Symplicity renal denervation system is available for investigational use only in the US.
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