<b>Edora ProMRI<b>

Edora 8 SR-T ProMRI

SMALLEST¹ MR CONDITIONAL PACEMAKER WITH MRI AUTODETECT

Edora 8 SR-T ProMRI^®. a 10 cc single chamber pacemaker, is designed with patient comfort in mind. This miniaturization is expected to be advantageous for smaller patients or varying patient anatomies. Compared to its predecessor, Edora’s reduced form factor has no negative effects on its battery, still boasting an impressive 13 years² of longevity in the single-chamber variant. Consistent with BIOTRONIK’s long-standing MRI leadership, Edora offers MRI AutoDetect, a revolutionary feature that is designed to improve efficiency for providers by eliminating the post-scan reprogramming requirement. It also aims to improve the patient experience by reducing the length of time the device is in MRI mode and the added benefit of flexibility in scheduling.

Key Facts

• Small Size: Improves patients’ comfort through a reduced device volume.
• MRI AutoDetect: Simplifies workflows through automatic detection of MRI environment and minimizes patients’ time in MRI mode.
• Closed-Loop Stimulation (CLS) is the only rate adaptation algorithm that is FDA-approved to respond to physiologic demands and acute mental stress, on a beat-to-beat basis.
• ProMRI^®3: Allows patients to undergo MR scanning under specific conditions
• Capture Control: Extends device longevity by automatically adjusting the pacing amplitudes.
• BIOTRONIK Home Monitoring^®: Effective remote monitoring of heart failure and system integrity based on automatic and wireless daily transmissions. BIOTRONIK Home Monitoring has been shown to extend the time between routine, scheduled in-office follow-ups of BIOTRONIK devices by the US Food and Drug Administration (FDA).
• SafeSync RF Telemetry: RF telemetry for wandless, time-saving and reliable data transmission at implantation and follow-up.
• Event-triggered wireless IEGM transmissions within 24 hours: Enable prompt evaluations for fast and better informed therapy decisions.

1 10 cc SR-T volume

2 AAI(R) @ 2.5 V, 0.4 ms, 60 ppm, 100% pacing, 500 Ω, RF-Telemetry: OFF

3 For combination of MR conditional devices, please see the "ProMRI^® MR conditional device systems" manual

Edora 8 DR-T ProMRI

MR CONDITIONAL PACEMAKER WITH MRI AUTODETECT

Edora DR-T ProMRI^® is designed with patient comfort in mind. This miniaturized MR conditional pacemaker is expected to be advantageous for smaller patients or varying patient anatomies. Compared to its predecessor, Edora’s reduced form factor has no negative effects on its battery, still boasting an impressive 9.3 years¹ of longevity in the dual chamber variant. Consistent with BIOTRONIK’s long-standing MRI leadership, Edora offers MRI AutoDetect, a revolutionary feature that is designed to improve efficiency for providers by eliminating the post-scan reprogramming requirement. It also aims to improve the patient experience by reducing the length of time the device is in MRI mode, and the added benefit of flexibility in scheduling.

Key Facts

• Small Size: Improves patients’ comfort through a reduced device volume.
• MRI AutoDetect: Simplifies workflows through automatic detection of MRI environment and minimizes patients’ time in MRI mode.
• Closed Loop Stimulation (CLS) is the only rate adaptation algorithm that is FDA-approved to respond to physiologic demands and acute mental stress, on a beat-to-beat basis.
• Capture Control (RA & RV): Improves patient safety and extends device longevity by automatically adjusting the pacing amplitudes.
• Vp Supression: Follows the natural rhythm and promotes the underlying intrinsic rhythm with on-demand ventricular pacing.
• ProMRI^®2:Allows patients to undergo MR scanning under specific conditions.
• BIOTRONIK Home Monitoring^®: Effective remote monitoring of heart failure and system integrity based on automatic and wireless daily transmissions. BIOTRONIK Home Monitoring has been shown to extend the time between routine, scheduled in-office follow-ups of BIOTRONIK devices by the US Food and Drug Administration (FDA).
• SafeSync RF Telemetry: RF telemetry for wandless, time-saving and reliable data transmission at implantation and follow-up.
• Event-triggered wireless IEGM transmissions within 24 hours: Enable prompt evaluations for fast and better informed therapy decisions.

1 DDD(R) @ 2.5 V, 0.4 ms, 60 ppm, 100% pacing, 500 Ω, RF-Telemetry: OFF

2 For combination of MR conditional devices, please see the "ProMRI^® MR conditional device systems" manual