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Evity Pacemaker Series
A New Generation of
BIOTRONIK Pacemakers
Asia Pacific CRM Marketing, April 2018
The Evity Pacemaker Series
Small, enduring, complete and smart.
Evity pacemakers combine small size with a complete suite of tools for Comprehensive
Diagnostics, Powerful Bradycardia Therapy and Facilitated Handling in a long-lasting wireless
device, supporting efficient MRI access, time-saving remote monitoring and unique
physiological rate adaptation.
Minimal size. Maximum Options.
= + + +
Small Enduring Complete Smart
BIOTRONIK Home
Monitoring®
The Most Reliable Remote
Monitoring System
ProMRI®
Approved for Full-Body MRI
Closed Loop Stimulation*
True Physiological Rate
Adaptation
The Evity Pacemaker Series
A New Generation of BIOTRONIK Pacemakers
Lighter, Smaller, and
Shorter
for improved patient
comfort
Excellent longevity
despite small size
for fewer device changes
and less complications
MRI AutoDetect
for less programming and less
time in MRI mode
Event-triggered IEGM*
transmissions within 24h
for fast and better informed
therapy decisions
SafeSync RF Telemetry
for wandless programming
Heart Failure Monitor to
check for HF indicators
Vp Suppression
for intrinsic rhythm support
Auto-Initialization
for facilitated implantation
Capture Control for extended
battery life by auto-adjusting
pacing amplitudes
TrendView* for long-term
parameter surveillance
New Features
+ BIOTRONIK Standards – full feature set uncompromised by small size
* Only available in Evity 8 SR-T & DR-T
EasyAV* for easy
programming of optimal AV
timing
Lighter, Smaller, and
Shorter
for improved patient
comfort
Excellent longevity
despite small size
for fewer device changes
and less complications
MRI AutoDetect
for less programming and less
time in MRI mode
New Features
The Evity Pacemaker Series
A New Generation of BIOTRONIK Pacemakers
E3 Single- and Dual-Chamber pacemakers compared to predecessor models
* E3 Single-Chamber pacemaker @20.8 gram with 3.2 gram weight reduction (13.33%)
E3 Dual-Chamber pacemaker @23.2 gram with 1.8 gram weight reduction (7.2%)
** E3 Single-Chamber pacemaker @10cc with 1cc volume reduction (9.1%)
E3 Dual-Chamber pacemaker @11cc with 1cc volume reduction (8.33%)
*** E3 Single- and Dual-Chamber pacemakers @48 mm length with 5mm length reduction (9.44%)
Lighter, Smaller and Shorter
For improved patient comfort
Shorter
9% shorter
can width***
Lighter
13% weight
reduction*
Smaller
9% volume
reduction**
• Long replacement intervals might reduce the risk of complications
• Evity SR-T and DR-T feature industry-leading device longevity, thereby limiting
replacements and avoiding associated risks
Excellent Longevity
Despite smaller size
* AAI(R) @ 2.5 V, 0.4 ms, 60 ppm, 50% pacing, 500 Ω, RF-Telemetry: OFF, Home Monitoring: OFF***
** DDD(R) @ A/V: 2.5 V, 0.4 ms, 60 ppm, 50% pacing, 500 Ω, RF-Telemetry: OFF, Home Monitoring: OFF***
*** Home Monitoring with daily transmissions reduces device longevity by 15%
14 years, 9 months
11 years, 4 months
0 2 4 6 8 10 12 14 16 years
Single-chamber IPG*
Dual-chamber IPG**
• 14 days of scheduling flexibility
• No reprogramming required after MRI
• Only one in-office visit is needed*
• Multiple MRI scans allowed within max 14 days
without additional programming
Intelligent built-in sensor automatically detects MR environment and
switches the system to a safe MRI-mode.
Less time in MRI-mode ensures
optimal patient therapy
Minimizing the time in MRI-mode to the
actual MRI scanning duration ensures
optimal pacing therapy.
Less programming simplifies workflows
The detection of the MR environment and
the automatic activation of the MRI mode,
eliminates additional programming, saves
time and increases efficiency.
MRI AutoDetect
Ensures optimal patient therapy and simplifies workflows
* When patients are monitored by BIOTRONIK Home Monitoring. See ProMRI manual for all details.
BIOTRONIK
Exclusive Feature
• The shortest time in MRI-mode possible
• Optimal therapy directly before and after the scan
• Automatic and fast switch back to original settings
• BIOTRONIK Home Monitoring® report after MRI
scan provides complete insight in patient status*
MRI AutoDetect
Ensures optimal patient therapy and simplifies workflows
* When patients are monitored by BIOTRONIK Home Monitoring. See ProMRI manual for all details.
Time in asynchronous pacing mode
Conventional MRI Workflow
Programming to
MRI mode
Reprogramming to previous
settings
Optimal Therapy Mode MRI Mode
Sensor window open for up to 14 days
System check & MRI Sensor
activation
No reprogramming needed,
Home Monitoring sends full
status report*
MRI AutoDetect Workflow
Optimal Therapy Mode Optimal Therapy Mode
MRI Mode
Patient in asynchronous pacing mode
BIOTRONIK
Exclusive Feature
The Evity Pacemaker Series
A new generation of BIOTRONIK pacemakers
+ BIOTRONIK Standards – full feature set uncompromised by small size
* Only available in Evity 8 SR-T & DR-T
BIOTRONIK Home
Monitoring®
The Most Reliable Remote
Monitoring System
ProMRI®
Approved for Full-Body MRI
Closed Loop Stimulation*
True Physiological Rate
Adaptation
Event-triggered IEGM*
transmissions within 24h
for fast and better informed
therapy decisions
SafeSync RF Telemetry
for wandless programming
Heart Failure Monitor to
check for HF indicators
Vp Suppression
for intrinsic rhythm support
Auto-Initialization
for facilitated implantation
Capture Control for extended
battery life by auto-adjusting
pacing amplitudes
TrendView* for long-term
parameter surveillance
EasyAV* for easy
programming of optimal AV
timing
The Evity Pacemaker Series Features Unique and
Proven BIOTRONIK Solutions
• Early detection of clinical events
• Safe reduction in-office follow-ups
• Fewer hospitalizations for AF related strokes
• Better device lifetime
Saving Time With BIOTRONIK Home Monitoring®
Providing Efficient MRI Access With ProMRI® Solutions
True Physiological Pacing and Powerful Therapy, Diagnostics & Handling
• MRI AutoDetect
• 1.5 T & 3.0 T full-body scans for higher image quality and reduced scanning time
• Wide Portfolio of MR conditional lead combinations for brady therapy
• Physiological rate adaptation with Closed Loop Stimulation (CLS)*
• Intrinsic rhythm support
• Tried and trusted BIOTRONIK features for powerful therapy, diagnostics, and
handling
* Only available in Evity 8 SR-T & DR-T
The Evity Pacemaker Series Saves Time with
BIOTRONIK Home Monitoring®
Mabo P et al. European Heart Journal 2011.
Ricci RP et al. Heart Rhythm. 2015 Feb;12(2):330-7.
Save Follow-up Time  Safe reduction of in-office follow-ups
Conventional FU intervals (6 to 12 months) can be safely prolonged to 18 months. COMPAS
demonstrated that BIOTRONIK Home Monitoring® reduced the number of interim in-office
follow-ups by 56% whilst making these follow-ups more clinically actionable (62% vs. 29% in
the control group; p <0.001; total n=494).1
Save Battery Lifetime  Better device longevity
Proper use of BIOTRONIK Home Monitoring® enables better and more effective programming,
offsetting the system's energy demand and resulting in better device longevity.2
Save Time to Detection  FDA approved for early detection of clinical events
While enabling continuous monitoring of system-related malfunctions, AF burden and HF
deteriorations, it allows for prompt discovery of specified ‘out-of bound’ conditions, even silent
issues and enables timely interventions. COMPAS demonstrated a time gain of 122 days for
medical intervention through early detection of clinically relevant events.1
Save Time in Hospital  Fewer hospitalizations for AF related strokes
COMPAS demonstrated a 66% reduction in hospitalizations for atrial arrhythmia and related
stroke in the Home Monitoring group.1
FDA & CE
approved
FDA & CE
approved
BIOTRONIK
Exclusive Feature
The Evity Pacemaker Series Provides Efficient
MRI Access with ProMRI® Solutions
• 1.5 T Full-body scans allow for additional diagnostics
• 3.0 T Full-body scans for higher image quality with reduced scanning time
• Intelligent built-in sensor automatically detects MR environment and switches
the system to a safe MRI-mode
• Ensures optimal patient therapy
• Simplifies workflows
• Programmable for multiple scans within a 2 weeks period
• Enabling a bigger choice for therapy and additional diagnostics
• Choice of 6F and 7F atrial and RV bipolar leads certified for MRI
(Solia - 5.6F lead body; Safio - 6.6F lead body)
MRI AutoDetect  Active MR Field Sensor
ProMRI®  More Options. More MRI.
Wide Portfolio  Flexibility for all Anatomies
The Evity Pacemaker Series Adds True Physiological
Pacing To Powerful Therapy, Diagnostics & Handling
• CLS closes the loop that has been interrupted by CI, using inotropy regulating
mechanisms to detect impedance changes in the cardiac tissue caused by the
ANS to identify metabolic demand
• CLS is the only primary sensor in the industry, therefore offering the most
physiological rate adaptation algorithm
• CLS provide rate response modulation during episodes of physical and
emotional stress
* Only available in Evity 8 SR-T & DR-T
Event-triggered IEGM
transmissions within 24h
for fast and better informed
therapy decisions
SafeSync RF Telemetry
for wandless programming and
device follow-up
Heart Failure Monitor
to check for HF indicators
Vp Suppression
for intrinsic rhythm support
Auto-Initialization
for facilitated implantation
Capture Control for extended
battery life by auto-adjusting
pacing amplitudes
Powerful Brady Therapy Comprehensive Diagnostics Facilitated handling
Closed Loop Stimulation  The Most Physiological Rate Adaptation*
TrendView* for long-term
parameter surveillance
EasyAV* for easy
programming of optimal AV
timing
Evity Pacemaker Series
A New Generation of
BIOTRONIK Pacemakers
Asia Pacific CRM Marketing, April 2018

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Evity Pacemaker Series - A New Generation of Small, Enduring, Complete and Smart Pacemakers

  • 1. Evity Pacemaker Series A New Generation of BIOTRONIK Pacemakers Asia Pacific CRM Marketing, April 2018
  • 2. The Evity Pacemaker Series Small, enduring, complete and smart. Evity pacemakers combine small size with a complete suite of tools for Comprehensive Diagnostics, Powerful Bradycardia Therapy and Facilitated Handling in a long-lasting wireless device, supporting efficient MRI access, time-saving remote monitoring and unique physiological rate adaptation. Minimal size. Maximum Options. = + + + Small Enduring Complete Smart
  • 3. BIOTRONIK Home Monitoring® The Most Reliable Remote Monitoring System ProMRI® Approved for Full-Body MRI Closed Loop Stimulation* True Physiological Rate Adaptation The Evity Pacemaker Series A New Generation of BIOTRONIK Pacemakers Lighter, Smaller, and Shorter for improved patient comfort Excellent longevity despite small size for fewer device changes and less complications MRI AutoDetect for less programming and less time in MRI mode Event-triggered IEGM* transmissions within 24h for fast and better informed therapy decisions SafeSync RF Telemetry for wandless programming Heart Failure Monitor to check for HF indicators Vp Suppression for intrinsic rhythm support Auto-Initialization for facilitated implantation Capture Control for extended battery life by auto-adjusting pacing amplitudes TrendView* for long-term parameter surveillance New Features + BIOTRONIK Standards – full feature set uncompromised by small size * Only available in Evity 8 SR-T & DR-T EasyAV* for easy programming of optimal AV timing
  • 4. Lighter, Smaller, and Shorter for improved patient comfort Excellent longevity despite small size for fewer device changes and less complications MRI AutoDetect for less programming and less time in MRI mode New Features The Evity Pacemaker Series A New Generation of BIOTRONIK Pacemakers
  • 5. E3 Single- and Dual-Chamber pacemakers compared to predecessor models * E3 Single-Chamber pacemaker @20.8 gram with 3.2 gram weight reduction (13.33%) E3 Dual-Chamber pacemaker @23.2 gram with 1.8 gram weight reduction (7.2%) ** E3 Single-Chamber pacemaker @10cc with 1cc volume reduction (9.1%) E3 Dual-Chamber pacemaker @11cc with 1cc volume reduction (8.33%) *** E3 Single- and Dual-Chamber pacemakers @48 mm length with 5mm length reduction (9.44%) Lighter, Smaller and Shorter For improved patient comfort Shorter 9% shorter can width*** Lighter 13% weight reduction* Smaller 9% volume reduction**
  • 6. • Long replacement intervals might reduce the risk of complications • Evity SR-T and DR-T feature industry-leading device longevity, thereby limiting replacements and avoiding associated risks Excellent Longevity Despite smaller size * AAI(R) @ 2.5 V, 0.4 ms, 60 ppm, 50% pacing, 500 Ω, RF-Telemetry: OFF, Home Monitoring: OFF*** ** DDD(R) @ A/V: 2.5 V, 0.4 ms, 60 ppm, 50% pacing, 500 Ω, RF-Telemetry: OFF, Home Monitoring: OFF*** *** Home Monitoring with daily transmissions reduces device longevity by 15% 14 years, 9 months 11 years, 4 months 0 2 4 6 8 10 12 14 16 years Single-chamber IPG* Dual-chamber IPG**
  • 7. • 14 days of scheduling flexibility • No reprogramming required after MRI • Only one in-office visit is needed* • Multiple MRI scans allowed within max 14 days without additional programming Intelligent built-in sensor automatically detects MR environment and switches the system to a safe MRI-mode. Less time in MRI-mode ensures optimal patient therapy Minimizing the time in MRI-mode to the actual MRI scanning duration ensures optimal pacing therapy. Less programming simplifies workflows The detection of the MR environment and the automatic activation of the MRI mode, eliminates additional programming, saves time and increases efficiency. MRI AutoDetect Ensures optimal patient therapy and simplifies workflows * When patients are monitored by BIOTRONIK Home Monitoring. See ProMRI manual for all details. BIOTRONIK Exclusive Feature • The shortest time in MRI-mode possible • Optimal therapy directly before and after the scan • Automatic and fast switch back to original settings • BIOTRONIK Home Monitoring® report after MRI scan provides complete insight in patient status*
  • 8. MRI AutoDetect Ensures optimal patient therapy and simplifies workflows * When patients are monitored by BIOTRONIK Home Monitoring. See ProMRI manual for all details. Time in asynchronous pacing mode Conventional MRI Workflow Programming to MRI mode Reprogramming to previous settings Optimal Therapy Mode MRI Mode Sensor window open for up to 14 days System check & MRI Sensor activation No reprogramming needed, Home Monitoring sends full status report* MRI AutoDetect Workflow Optimal Therapy Mode Optimal Therapy Mode MRI Mode Patient in asynchronous pacing mode BIOTRONIK Exclusive Feature
  • 9. The Evity Pacemaker Series A new generation of BIOTRONIK pacemakers + BIOTRONIK Standards – full feature set uncompromised by small size * Only available in Evity 8 SR-T & DR-T BIOTRONIK Home Monitoring® The Most Reliable Remote Monitoring System ProMRI® Approved for Full-Body MRI Closed Loop Stimulation* True Physiological Rate Adaptation Event-triggered IEGM* transmissions within 24h for fast and better informed therapy decisions SafeSync RF Telemetry for wandless programming Heart Failure Monitor to check for HF indicators Vp Suppression for intrinsic rhythm support Auto-Initialization for facilitated implantation Capture Control for extended battery life by auto-adjusting pacing amplitudes TrendView* for long-term parameter surveillance EasyAV* for easy programming of optimal AV timing
  • 10. The Evity Pacemaker Series Features Unique and Proven BIOTRONIK Solutions • Early detection of clinical events • Safe reduction in-office follow-ups • Fewer hospitalizations for AF related strokes • Better device lifetime Saving Time With BIOTRONIK Home Monitoring® Providing Efficient MRI Access With ProMRI® Solutions True Physiological Pacing and Powerful Therapy, Diagnostics & Handling • MRI AutoDetect • 1.5 T & 3.0 T full-body scans for higher image quality and reduced scanning time • Wide Portfolio of MR conditional lead combinations for brady therapy • Physiological rate adaptation with Closed Loop Stimulation (CLS)* • Intrinsic rhythm support • Tried and trusted BIOTRONIK features for powerful therapy, diagnostics, and handling * Only available in Evity 8 SR-T & DR-T
  • 11. The Evity Pacemaker Series Saves Time with BIOTRONIK Home Monitoring® Mabo P et al. European Heart Journal 2011. Ricci RP et al. Heart Rhythm. 2015 Feb;12(2):330-7. Save Follow-up Time  Safe reduction of in-office follow-ups Conventional FU intervals (6 to 12 months) can be safely prolonged to 18 months. COMPAS demonstrated that BIOTRONIK Home Monitoring® reduced the number of interim in-office follow-ups by 56% whilst making these follow-ups more clinically actionable (62% vs. 29% in the control group; p <0.001; total n=494).1 Save Battery Lifetime  Better device longevity Proper use of BIOTRONIK Home Monitoring® enables better and more effective programming, offsetting the system's energy demand and resulting in better device longevity.2 Save Time to Detection  FDA approved for early detection of clinical events While enabling continuous monitoring of system-related malfunctions, AF burden and HF deteriorations, it allows for prompt discovery of specified ‘out-of bound’ conditions, even silent issues and enables timely interventions. COMPAS demonstrated a time gain of 122 days for medical intervention through early detection of clinically relevant events.1 Save Time in Hospital  Fewer hospitalizations for AF related strokes COMPAS demonstrated a 66% reduction in hospitalizations for atrial arrhythmia and related stroke in the Home Monitoring group.1 FDA & CE approved FDA & CE approved BIOTRONIK Exclusive Feature
  • 12. The Evity Pacemaker Series Provides Efficient MRI Access with ProMRI® Solutions • 1.5 T Full-body scans allow for additional diagnostics • 3.0 T Full-body scans for higher image quality with reduced scanning time • Intelligent built-in sensor automatically detects MR environment and switches the system to a safe MRI-mode • Ensures optimal patient therapy • Simplifies workflows • Programmable for multiple scans within a 2 weeks period • Enabling a bigger choice for therapy and additional diagnostics • Choice of 6F and 7F atrial and RV bipolar leads certified for MRI (Solia - 5.6F lead body; Safio - 6.6F lead body) MRI AutoDetect  Active MR Field Sensor ProMRI®  More Options. More MRI. Wide Portfolio  Flexibility for all Anatomies
  • 13. The Evity Pacemaker Series Adds True Physiological Pacing To Powerful Therapy, Diagnostics & Handling • CLS closes the loop that has been interrupted by CI, using inotropy regulating mechanisms to detect impedance changes in the cardiac tissue caused by the ANS to identify metabolic demand • CLS is the only primary sensor in the industry, therefore offering the most physiological rate adaptation algorithm • CLS provide rate response modulation during episodes of physical and emotional stress * Only available in Evity 8 SR-T & DR-T Event-triggered IEGM transmissions within 24h for fast and better informed therapy decisions SafeSync RF Telemetry for wandless programming and device follow-up Heart Failure Monitor to check for HF indicators Vp Suppression for intrinsic rhythm support Auto-Initialization for facilitated implantation Capture Control for extended battery life by auto-adjusting pacing amplitudes Powerful Brady Therapy Comprehensive Diagnostics Facilitated handling Closed Loop Stimulation  The Most Physiological Rate Adaptation* TrendView* for long-term parameter surveillance EasyAV* for easy programming of optimal AV timing
  • 14. Evity Pacemaker Series A New Generation of BIOTRONIK Pacemakers Asia Pacific CRM Marketing, April 2018