Intended Use - Medtronic Symplicity Spyral Handbuch

Symplicity Spyral™
Multi-Electrode Renal Denervation Catheter
1. Product Description
The Symplicity Spyral™ multi-electrode renal denervation catheter is designed to be used with the Symplicity G3™ renal denervation RF generator. The Symplicity Spyral™ catheter
connects to the Symplicity G3™ generator using the integrated cable attached to the catheter handle. To function properly, the catheter requires the use of a 0.36 mm (0.014 in) guidewire
(preferably non hydrophilic coated). In addition, a standard dispersive electrode (also known as neutral electrode, return electrode pad, or grounding pad) must be placed on the patient
and connected to the Symplicity G3™ generator for the therapy to be delivered. Other ancillary devices include the Symplicity G3™ generator, optional foot switch, and cart. The
Symplicity Spyral™ catheter is 6 Fr guide catheter compatible and is designed for treating in vessels with diameters ranging from 3 to 8 mm. As shown in Figure 1, the catheter features
4 radiopaque electrodes at the spiral (helical) distal end. The electrodes are deployed into a spiral (helical) shape by partially retracting the guidewire into the Symplicity Spyral™ catheter.
The treatment length (distance between electrodes 1 and 4) of the Symplicity Spyral™ catheter changes with the vessel diameter (refer to Table 1 for the treatment length for each
diameter). A radiopaque tip marker is located 1 mm proximal from the Symplicity Spyral™ catheter tip and assists in the positioning of the Symplicity Spyral™ catheter using fluoroscopic
guidance. The catheter also features a straightening tool that facilitates safe insertion of the guidewire into the catheter (Figure 2). This tool is located near the handle, and slides along
the catheter shaft to straighten the distal end.
Vessel Diameter (mm)
3
4
5
6
7
8
Figure 3. Representative image of the Symplicity G3™ renal denervation RF generator displaying a ready state screen
The Symplicity G3™ generator is represented in Figure 3. The front panel touchscreen shows information such as temperature, impedance, ablation time, and messages (refer to
Symplicity G3™ generator user manual for additional details). The front panel also features an RF activation button. Electrode identifiers on the Symplicity G3™ generator screen
correspond to each electrode on the Symplicity Spyral™ catheter (refer to Figure 1 and Figure 3). The Symplicity G3™ generator touchscreen allows the user to select different options,
eg, selection/deselection of channels, viewing previous ablation data sets or selecting left or right kidney. The Symplicity G3™ generator uses an automated algorithm that controls the
power and time settings for use with the Symplicity Spyral™ catheter (refer to the Symplicity G3™ generator user manual for further information).

2. Intended Use

The Symplicity Spyral™ multi-electrode renal denervation catheter is intended to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human
kidney.
3. Indications for Use
The Symplicity Spyral™ multi-electrode renal denervation catheter is indicated for the treatment of uncontrolled hypertension.
4. Conditions for Use
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The Symplicity Spyral™ catheter is intended for single use only.
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2013/JUL/16 at 10:32 a.m. Doc number: M333565F001 Rev. 1A [28L(03)]
Printspec j - 8.5 x 11.0 inches
4
Figure 1. Symplicity Spyral™ multi-electrode renal denervation catheter electrode configuration
Table 1. Treatment length: Distance between electrodes 1 and 4 as a function of deployed diameter
Figure 2. Straightening tool used over the distal portion of the Symplicity Spyral™ catheter
3
2
1
Treatment Length (mm)
21
20
20
19
18
17
Instructions for Use English 3