Optimizer Smart IPG - Cardiac contractility modulation system pulse generator

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

지금 구매하세요

공공 평가 보고서 공공 평가 보고서 (PAR)
02-11-2017

제공처:

Impulse Dynamics (Australia) Pty Ltd

수업:

AIMD

Manufactured by:

Impulse Dynamics (USA) Inc 50 Lake Center Suite 100, Marlton, NJ, 08053 United States Of America

치료 영역:

47468 - Cardiac contractility modulation system pulse generator

치료 징후:

The OPTIMIZER SMART IPG is an implantable device designed for subcutaneous implant in the upper chest. The IPG delivers Cardiac Contractility Modulation (CCM) signals to the heart via two standard pacing leads attached to the right ventricular septum. When delivering CCM therapy, the IPG continuously monitors the heart?s intrinsic activity via two ventricular sense amplifiers, and generates CCM signals in synchrony with the detected local electrical activity. The Optimizer SMART Implantable Pulse Generator (IPG) is indicated for use in patients who are older than 18 years of age with symptomatic heart failure due to systolic left ventricular dysfunction despite appropriate medical therapy. The Optimizer SMART IPG delivers non-excitatory CCM signals to the heart and has no pacemaker or ICD functions.

승인 상태:

A

승인 날짜:

2017-08-30

이 제품과 관련된 검색 알림