Symplicity Spyral Multi-Electrode Renal Denervation Catheter

Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter

The Symplicity SpyralTMmulti-electrode renal denervation catheter is a minimally invasive, single-use renal denervation catheter for exclusive use with the Symplicity G3TM renal denervation RF generator. Built on Symplicity™ technology by Medtronic, this next generation device is designed to improve the renal denervation procedure and help bring patients with hypertension under control.

How does the Symplicity Spyralcatheter work?

The 4FrSymplicity Spyral catheter is delivered over a standard 0.014” guide wire via a rapid exchange system. A spiral distal tip is deployed by retracting the guide wire into the catheter lumen
Its multi-electrode design delivers energy to each quadrant of the vessel, thus maximizing damage to the sympathetic nerves around the renal vessel in a consistent four quadrant ablation pattern
The consistent and precise helical ablation pattern of the catheter delivers RF energy simultaneously to all four electrodes while independently monitoring temperature and impedance for 60 seconds per treatment

What are the benefits for using the Symplicity Spyralcatheter?

Low 4Fr profile catheter, flexible tip, and wire-based design allows exceptional deliverability
Offersfast, 60-second ablations with four electrodes delivering energy simultaneously and independently monitoring safety
Self-expanding helical design delivers consistent lesion pattern
Conforms to a wide range of artery shapes and sizes (3mm to 8mm in diameter), eliminating the need for multiple catheters per procedure

What is the role of the Symplicity G3 renal denervation RF generator?

The Symplicity G3 generator independentlymonitors safety for each electrode and the touchscreen interface allows customization of the electrodes activated
Applies power while simultaneously and independently monitoring temperature and impedance to prevent tissue overheating
Symplicity algorithms are capable of adjusting therapy within 20ms

What data supportsthe Symplicity Spyral catheter?

Data from the SYMPLICITY Spyral feasibility studyshowed that patients treated with the Symplicity Spyral catheter had an average office SBP reduction of19 mmHg at 12 months (n=48) and demonstrated excellent procedural safety[1]

[1]Whitbourn, R., et al. Renal artery denervation with a new simultaneous multi-electrode catheter for treatment of resistant hypertension: 12-month update from the first-in-man study. Abstract presented at: TCTconference; 2014;