System Overview - BIOTRONIK Idova 7 Manual Tecnico

We recommend observing the indications published by the German Cardiac Society
(Deutsche Gesellschaft für Kardiologie, Herz- und Kreislaufforschung) and the ESC
(European Society of Cardiology). This also applies to the guidelines published by the
Heart Rhythm Society (HRS), the American College of Cardiology (ACC), the American
Heart Association (AHA), and other national cardiology associations.
Single-chamber and dual-chamber
Single-chamber and dual-chamber ICDs are indicated for patients with the following
risk:
• Sudden cardiac death caused by ventricular arrhythmias
Triple-chamber
Triple-chamber ICDs are indicated for patients with the following risks:
• Sudden cardiac death caused by ventricular arrhythmias
• Congestive heart failure with ventricular asynchrony
Also indicated for primary prophylaxis in congestive heart failure patients isIdova.
Contraindications
Known contraindications:
• Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning, elec-
trolyte imbalance, hypoxia, sepsis or acute myocardial infarction
• Such frequent VT or VF that the therapies would cause an unacceptably rapid
depletion of the device batteries
• VT with few or without clinically relevant symptoms
• VT or VF treatable by surgery
• Concomitant diseases that would substantially limit a positive prognosis
• Accelerated idioventricular rhythm

System Overview

Device family
The complete Idova 7 device family consists of several device types with a DF-1/IS-1 or
DF4/IS-1 connection.
Single-chamber: VR-T and VR-T DX (only devices with a DF-1/IS-1 connection); dual-
chamber: DR-T; triple-chamber: HF-T. Not all device types are available in every
country.
en • English
Device
The device's housing is made of biocompatible titanium, welded from outside and thus
hermetically sealed. The ellipsoid shape facilitates implantation in the pectoral muscle
area. The connections for bipolar pacing and sensing (and unipolar connections for the
triple-chamber device) as well as for shock delivery are found in the device header. The
housing serves as a potential antipole during shock delivery or in the case of unipolar
lead configuration.
DF-1/IS-1 or DF4/IS-1
BIOTRONIK provides ICDs with headers for different standardized lead connections:
DF-1/IS-1 and DF4/IS-1.
Note: The device type DX can only be connected using a DF-1/IS-1 connector.
DF-1/IS-1 lead connection
The device labeling provides information pertaining to possible lead connections
depending on the device type and pertaining to connection assignment:
VR DX
DF-1
DF-1
SVC
SVC
DF-1
DF-1 IS-1
RV RV RV
Connector Lead Configuration
port connector
RV DF-1 Shock coil
SVC DF-1 Shock coil
RA IS-1 Bipolar
(R)V IS-1 Bipolar
LV IS-1 Unipolar, bipolar
3
DR HF
IS-1 DF-1 IS-1
SVC RA
RA
DF-1
IS-1 DF-1 IS-1
SVC
RV RV
RV
DF-1
RV
Implantation site Device type
Right ventricle VR, DX, DR, HF
Superior vena VR, DX, DR, HF
cava
Atrium DX, DR, HF
(Right) ventricle VR, DX, DR, HF
Left ventricle HF
IS-1
LV
IS-1
RA
IS-1
RV