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Cardio.>Arrhytmia. 3D NonInvasive Loca-lization System.
Intended>ACQuisition, Analysis, Display
& storage of cardiac electro-
physiology data and maps for
analysis by a physician.
Intended>Used as Pre-Procedure>Planning
tool for patients with structu-
rally normal hearts undergoing
ablation treatment for idiopa-
thic ventricular arrhythmias.
System Consists of a hand-held 3D came-
ra, & an off-the-shelf laptop
computer with proprietary soft-
ware.
System Uses MRI or CT Scan along with a
standard 12-lead ΕCG to computer-
generate color-coded 3D mapping
images of the heart to indicate
the area of earliest activation.
Using a 3D photograph of the pa-
tient s chest, an MRI or CT
(DICOM image), and a standard 12-
lead ECG, the system generates a
3D rendering of the patient s
heart with superimposed color
coding to indicate the area of
earliest activation.
EU Approval Year : 2017.
USA Approval Date: 2019. 06.26.
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2019. 07.07.




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