Cardiac extracorporeal shock wave therapy system
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
04-11-2017
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Available from:
Intervene Medical Pty Ltd
Class:
Class IIb
Manufactured by:
Medispec Ltd 40 Hataasiya Street, Yehud, 56101 Israel
Therapeutic area:
47548 - Cardiac extracorporeal shock wave therapy system
Therapeutic indications:
Cardiospec Extracorporeal Shockwave Myocardial Revascularization (ESMR) system is indicated for treating patients with ischemic heart disease unsuitable for conventional methods of revascularization, treated with optimal medical management and who have documented myocardial segments with reversible ischemia and/or hibernation on the basis of echocardiography/single photon emission CT/SPECT/PET/MRI/.
Authorization status:
A
Authorization date:
2016-11-24
