Isolator Synergy - Electrode, electrosurgical, active, cardiac ablation, single-use

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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Download 공공 평가 보고서 (PAR)
16-11-2017

제공처:

AA-Med Pty Ltd

수업:

Class III

Manufactured by:

Atricure Inc 7555 Innovation Way, Mason, Ohio, 45040 United States Of America

치료 영역:

44661 - Electrode, electrosurgical, active, cardiac ablation, single-use

치료 징후:

The ISOLATOR is an electrosurgical instrument used for cardiac tissue ablation. When activated, the Ablation and Sensing Unit generator delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the ISOLATOR. ISOLATOR devices are configured as vascular clamps and feature clamping jaws of various lengths. The ISOLATOR Synergy Clamps feature two pairs of opposing dual electrodes, an in-line handle with syringe-type actuation and button release mechanisms. It is intended to be used to create lesions within the heart to eliminate or reduce cardiac conduction and treat cardiac arrhythmia using radio frequency energy, supplied by a separate generator. It can be used during pulmonary vein isolation and atrial connecting lesions for the Maze procedure for the treatment of cardiac arrhythmias including atrial fibrillation. It can also be used for lesions on soft tissue, such as the pulmonary vein.

승인 상태:

A

승인 날짜:

2009-07-20

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