Table 1.
Device type | Connectora | Device models |
---|---|---|
Pulse generator | ||
Single-chamber ICD | DF-1 or DF-4 | Ilesto 5, Ilesto 7, Iforia 5, and Iforia 7 (VR-T)b |
Dual-chamber ICD | DF-1 or DF-4 | Ilesto 5, Ilesto 7, Iforia 5, and Iforia 7 (DR-T)b |
ICD DX | DF-1 | Ilesto 5, Ilesto 7, Iforia 5, and Iforia 7 (VR-T DX)b |
CRT-D | DF-1 or DF-4 | Ilesto 5, Ilesto 7, Iforia 5, and Iforia 7 (HF-T)b |
CRT-P | — | Evia and Entovis (HF-T)b |
Lead categoryc | ||
ICD lead with DF-1 | DF-1 | Linoxsmart ProMRI S (65, 75)d |
Linoxsmart ProMRI SD (65/16, 65/18, 75/18)e | ||
fLinoxsmart ProMRI S DX (65/15, 65/17)e | ||
ICD lead with DF-4 | DF-4 | gProtego ProMRI SD (65/16, 65/18, 75/18)e |
hProtego ProMRI S (65, 75)d | ||
Solia | — | Solia S (45, 53, 60)d (atrial and ventricular leads) |
Corox | — | Corox ProMRI OTW (75 BP, 85 BP)d |
Corox ProMRI OTW-L (75 BP, 85 BP)d | ||
Corox ProMRI OTW-S (75 BP, 85 BP)d |
aDF-4 connector (four-pole inline) is a new standard since 2010, gradually replacing the bulkier DF-1 connector (bi- or trifurcated) in ICDs/CRT-Ds17.
bSuffix “-T” in pulse generator name indicates Biotronik Home Monitoring® function.
cFor the primary endpoint 1, leads were grouped into these four categories. ICD and Solia leads were screw-in. Corox coronary sinus leads for CRT-D/-P devices (in addition to atrial lead and ICD or ventricular lead) have a pre-shaped distal section and are positioned by an over-the-wire or stylet-driven technique.
dLength of the lead in cm.
eLength of the lead in cm/ distance of proximal shock coil to lead tip in cm.
fLead for the ICD DX.
gPreviously labeled as Linoxsmart ProMRI DF4 SD (65/16, 65/18, 75/18).
hLead added to the study by later protocol amendments and available for European sites only.
BP: bipolar; CRT-D/-P: cardiac resynchronisation therapy defibrillator/pacemaker; DX: ICD lead allowing atrial sensing via floating dipole16; ICD: implantable cardioverter-defibrillator; MRI: magnetic resonance imaging; ProMRI: MRI-conditional.