Edora 8 DR-T/SR-T
MINIMAL SIZE. MAXIMUM OPTIONS.Small, Enduring, Complete, Smart - Edora 8 pacemakers combine small size with a complete suite of tools for comprehensive diagnostics, powerful bradycardia therapy and facilitated handling— yielding long-lasting wireless devices that support efficient MRI access, timesaving remote monitoring and unique physiological rate adaptation.
Key Facts
- Smaller, Lighter, Shorter – With only 10 cc in volume, 20.8 g of weight and 48 mm length1 Edora pacemakers are among the smallest full-feature pacemakers in the market. Designed to improve wearing comfort and aesthetic outcomes, Edora pacemakers may also allow for smaller incisions and pocket size.
- BIOTRONIK Home Monitoring® – Effective remote monitoring of heart failure and system integrity based on automatic and wireless daily transmissions - enables earlier intervention and Home Monitoring-supported follow-ups that are approved by the U.S. FDA and CE Notified Body.
- Event-triggered IEGM transmissions – Enable prompt evaluations for fast and better-informed therapy decisions.
- ProMRI® – allows patients to undergo MRI scanning under specific conditions.
- MRI AutoDetect – Simplifies MRI access by automatically detecting an MR environment and switching the system to safe MRI mode, programmable for up to 14 days.
- Closed Loop Stimulation (CLS) – Is a unique physiological rate response modulation that is able to adapt the heart rate in response to both physical and emotional stress.
- Capture Control – Improves patient safety and extends device longevity by automatically adjusting pacing amplitudes.
- Vp Suppression – Follows a natural rhythm and promotes the underlying intrinsic rhythm with on-demand ventricular pacing.
- EasyAV – Facilitates the programming of optimal AV timing.
- SafeSync RF telemetry – Is wandless and saves time when transmitting data reliably at implantation and follow-up.
- Heart Failure Monitor – Enables early detection of changes in patients’ heart failure conditions with the continuous monitoring of clinical parameters.
- TrendView – Displays channels' electrical trends over the last 240 days, allowing the user to check the system's stability over time.
- Auto-Initialization - Activates essential pacemaker functions and follow-up data within 10 minutes.
Product Features
Small, Enduring, Complete, Smart
Small Size
Smaller, Lighter, Shorter – With only 10 cc in volume, 20.8 g of weight and 48 mm length, Edora pacemakers are among the smallest full-feature pacemakers in the market.
Excellent Longevity
Bringing Small Size and Excellent Longevity Together – Edora pacemakers’ small size does not compromise battery lifetime – providing outstanding longevity.
Enabling Efficient MRI Access
ProMRI® – Approved for full-body MRI
Saving Valuable Time
BIOTRONIK Home Monitoring® – The most reliable remote monitoring system. Saving time to detection, follow-up time, hospitalization time, and even battery lifetime.2,3,4
Simplifying MRI Access
MRI AutoDetect – For less programming and less time in MRI mode, ensuring optimal therapy and simplified workflows
Supporting Physiological Pacing
Closed Loop Stimulation (CLS) – Unique physiological rate-adaptive technology, able to determine the appropriate heart rate response during episodes of physical and emotional
Promoting Intrinsic Rhythm
Vp Suppression – Reducing unnecessary pacing by following the natural rhythm and promoting the underlying intrinsic rhythm with on-demand ventricular pacing
Wandless Communication
SafeSync RF Telemetry – RF telemetry for wandless, time-saving and reliable data transmission at implantation and follow-up.
Extended Battery Life
Capture Control – Improves patient safety and extends device longevity by automatically adjusting the pacing
Event Notification within 24h
Event-triggered IEGM transmissions – Enable prompt evaluations for fast and better-informed therapy decisions.
Longterm Surveillance of System Status
TrendView – Displays the electrical trends of the channels over the last 240 days, allowing the user to check the system's stability over time.
Monitor HF Status
Heart Failure Monitor – Comprehensive set of parameters to continuously evaluate patients’ heart failure status
Product Details
BIOTRONIK Home Monitoring
BIOTRONIK Home Monitoring is a remote monitoring service available with cardiac monitors, pacemakers, implantable defibrillators (ICDs) and cardiac resynchronization therapy (CRT) systems. Home Monitoring allows physicians to continuously and reliably survey patients’ device and physiological condition, and alerts responsible healthcare staff of acute health changes within 24 hours.
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ProMRI
ProMRI technology offers patients safe access to MRIs under certain conditions.
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MRI AutoDetect
MRI AutoDetect minimizes the time in MRI mode to the duration of the scan itself, ensuring optimal pacing directly before and after MRI scan. Detection of the MR environment and automatic activation of the MRI mode eliminate additional programming, save time and increase efficiency.
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Closed Loop Stimulation (CLS)
CLS is a unique physiological rate-adaptive technology. The feature is able to determine the appropriate heart rate response during episodes of physical and emotional stress.
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Media
MRI AutoDetect
BIOTRONIK ProMRI technology enables patients with a pacemaker, implantable defibrillator, cardiac monitor, or cardiac resynchronization therapy defibrillator (CRT-D) or pacemaker (CRT-P) to undergo an MRI scan. BIOTRONIK IPGs, ICDs and CRT devices with MRI AutoDetect have the additional capability of automatically recognizing an MR environment within a programmable time window, switching on the device’s MRI mode for only as long as is required to complete the scan, about 30 minutes. This keeps patients safer by reducing the amount of time their device is in MRI mode with limited device therapy.
Closed Loop Stimulation
BIOTRONIK Closed Loop Stimulation Offers the Most Physiological Rate Regulation
1 Edora 8 single-chamber pacemaker ; Edora 8 dual-chamber pacemaker is only 11 cc in volume, weighing 23.2 g
2 Mabo P. et al. A Randomized Trial of Long-Term Remote Monitoring of Pacemaker Recipients (The COMPAS Trial). European Heart Journal 2011; doi: 10.1093/eurheartj/ehr419.
3 Ricci RP et al. Heart Rhythm. 2015 Feb; 12(2):330–7. Effect of daily remote monitoring on pacemaker longevity: a retrospective analysis. A retrospective analysis of 201 patients prolonged average longevity from 60.4 to 71.1 months—11 months of longevity gained on average.
4 Varma et al. Evaluation of efficacy and safety of remote monitoring for ICD follow-up: The TRUST trail; Circulation 2008; 118:22;p.2316; Abstract 4078.