Medtronic announced it has received CE Mark approval and Therapeutic Goods Administration (TGA) listing for the Symplicity Spyral Multi-Electrode catheter and Symplicity G3 Generator, a renal denervation system designed to improve deliverablity and speed-up the ablation process.This system builds on the predicate single electrode Symplicity device, which featured the Symplicity treatment algorithm and helical ablation pattern. Along with a compliant catheter shaft, the Symplicity Spyral will have four electrodes, with the ability to stimulate each one with a unique radio frequency or all four simultaneously. This provides physicians more precision in the renal denervation procedure.
The Symplicity Spiral is powered by the Symplicity G3 RF generator, featuring a touch screen interface that is also compatible with the previous Symplicity device.
Clinical trial results showed patients treated with the Symplicity Spyral had an average blood pressure reduction of 16/7 mmHg one month post-procedure and an average drop in heart rate of 4.3 beats per minute (BPM). Furthermore, the average procedure lasted 21 minutes as compared with 54 minutes observed in the original Symplicity HTN-2 clinical trials.
Symplicity and Symplicity Spyral are both currently available in the US for investigational use only.
The new 4 Fr catheter is compatible with a 6 Fr guide catheter and is delivered over a 0.014 inch guide wire 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 non-occlusive design ensures the catheter will not obstruct renal blood flow during the procedure.
Flashbacks: Flashback: Medtronic Symplicity Renal Denervation System Potentially Cost-Effective and May Reduce Clinical Events in Treatment-Resistant Hypertension; Medtronic Starts Trial with Symplicity Renal Denervation System for Chronic Heart Failure and Renal Impairment; Medtronic Gets FDA Nod for Renal Denervation Trial; Ardian’s Hypertension Treatment Outperforms Traditional Medical Treatment in Clinical Trial