EnligHTN™ Multi-Electrode Renal Denervation System RF Ablation Generator
CARDIOVASCULAR
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EnligHTN™

Multi-Electrode Renal Denervation System RF Ablation Generator

The EnligHTN™

DESCRIPTION

The EnligHTN™ RF ablation generator is intended to deliver RF energy to the EnligHTN™ renal artery ablation catheter.


PRODUCT HIGHLIGHTS

  • The touch screen RF ablation generator is a component of the EnligHTN™ renal denervation system and facilitates control and monitoring of the ablation process
  • Temperature-controlled system with four independent monitoring channels
  • Pre-programmed default settings for use with the EnligHTN renal artery ablation catheter
  • Proprietary algorithm designed to produce consistent, transmural renal artery ablations
  • Automatic safety shutoff at ablation completion and in the event temperatures or impedance exceed the pre-set or safety limits
  • Ability to selectively disable EnligHTN™ ablation electrodes if desired
  • Report summary of the procedure available via USB download. It is not necessary to ablate both arteries to get a report

ORDERING INFORMATION


Reorder Number Description
ENL-GEN2 EnligHTN™ Multi-Electrode Renal Denervation System RF Ablation Generator
ENL-LG-01 Ablation catheter required for use with the EnligHTN RF ablation generator.
ENL-SM-01 Ablation catheter required for use with the EnligHTN RF ablation generator.
ENL-8F55 Guiding catheter facilitates percutaneous introduction of the EnligHTN renal artery ablation catheter.

Reorder Number Description
ENL-CC-02 Reusable cables to connect the ablation catheter with the adapter cable. See the ENL-CC-02 Electrophysiology Cable Instructions for Use for resterilization instructions. Replacement connector cables may be ordered separately.
ENL-ADAPT Reusable adapter cable to connect the electrophysiology cable with the generator. Replacement connector cables may be ordered separately.
RETURN-02 Patient return electrodes used with the EnligHTN renal denervation system must be IEC 60601-2-2 compliant. Replacement patient return electrodes must be ordered separately.
POLE-02 The mounting pole supports positioning and placement of the RF generator during treatment.
ENL-FP-01 The EnligHTN Footswitch is used to activate or deactivate the EnligHTN RF Ablation Generator.
DRAPE-02 The sterile drape provides a sterile cover for the RF generator touchscreen while allowing adequate ventilation for the back side of the RF generator under description.
ENL-PC-02 EnligHTN Power Cord: Medical-grade power supply approved by international safety agencies. This power supply can be used for various line voltages and frequencies without any modifications. Replacement power cables may be ordered separately.

Rx Only

 

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

 

Product referenced is approved for CE Mark.

SJM-HTN-0616-0023

Last Updated: January 02, 2019

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