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SAFER™

AV MANAGEMENT ALGORITHM

PRESERVING NATURAL CONDUCTION

Beating for the past two decades, SafeR™ has stood as the sole clinically proven solution to drastically reduce ventricular pacing, promoting natural AV conduction while ensuring long-term safety and efficacy for both you and your patients.1

SafeR™, powered by an exclusive technology, is a unique and versatile algorithm that offers you the freedom to create personalized therapies for both SND and AVB patients while safeguarding spontaneous AV conduction, leading to an extended device longevity.2

KEY BENEFITS

SIGNIFICANT REDUCTION OF V PACING​ COMPARED TO DDD

SAFE AND EFFECTIVE FOR ALL PACEMAKER PATIENTS

SIGNIFICANT RISK REDUCTION OF AF AND HF HOSPITALIZATION

EXTENDING DEVICE LONGEVITY

UNIQUE LONG PR MANAGEMENT

HEMODYNAMIC SUPPORT​ DURING EXERCISE

FULL DIAGNOSTICS WITH EGMs

SIGNIFICANT REDUCTION OF V PACING​ COMPARED TO DDD

SAFE AND EFFECTIVE FOR ALL PACEMAKER PATIENTS

SIGNIFICANT RISK REDUCTION OF AF AND HF HOSPITALIZATION

EXTENDING DEVICE LONGEVITY

UNIQUE LONG PR MANAGEMENT

HEMODYNAMIC SUPPORT​ DURING EXERCISE

FULL DIAGNOSTICS WITH EGMs

SIGNIFICANT REDUCTION OF V PACING​ COMPARED TO DDD

Excessive right ventricular pacing leads to increased risk of:​

  • Atrial fibrillation3,4,5,6

  • Heart failure hospitalization3,6,7​

  • Heart failure events and cardiac death8​

SafeR™ is the only AV management solution proven to safely and effectively reduce Vp for both AV block and SND patients​.

  • SafeR™ significantly reduces V pacing compared to DDD after 3 years follow-up – From the ANSWER STUDY

  • SafeR™ reduces unnecessary ventricular pacing to almost 0%​ for SND & AV block patients at rest & during exercise9

     

SAFE AND EFFECTIVE FOR ALL PACEMAKER PATIENTS

SafeR™ has been proven to be safe and effective for all pacemaker patients including those with AV Block or Sinus Node Disease.1

SafeR™ is activated by default 20 minutes after automatic detection of implantation.

SafeR™ is the only algorithm proven to effectively switch from AAI mode to DDD mode ​in all cases of AV block, including 1st degree AVB.1,2

SIGNIFICANT RISK REDUCTION OF AF AND HF HOSPITALIZATION

SafeR™ reduces the risk of first Atrial Fibrillation onset by 23% in ALL patients and by 35% in AV Block patients.1

SafeR™ showed a 51% risk reduction in experiencing cardiac death or HF hospitalization and 30% RR in experiencing cardiovascular hospitalizations for SND & AV block patients.1

 

EXTENDING DEVICE LONGEVITY

SafeR™ provides a greater longevity for intermittent AV Block patients as well as SND patients 2 – From the ANSWER SUB-STUDY​:

  • More than 1 year device longevity gain with SafeR™2
  • SafeR™ avoids device replacements versus DDD mode2

With SafeR™ mode, 28% of women and 23% of men would avoid one pacemaker replacement when compare to DDD mode.

 

UNIQUE LONG PR MANAGEMENT

The SafeR™ algorithm is designed to reduce ventricular pacing while  managing long PR at rest and during exercice. This means that SafeR™ switches from AAI mode to DDD mode in cases of long PR.

  • Personalised long PR parameters​

The duration of the PR intervals is programmable (up to 500ms). ​
The settings can be adjusted to suit the patient’s activity both at rest and during exercise.

  • Intelligent management of Long PR interval to protect patients against deleterious effects of long PR​

HEMODYNAMIC SUPPORT​ DURING EXERCISE

To avoid symptoms associated with any type of AV block during exercise, after 3 switches to DDD during exercise, pacing mode will remain in DDD until the end of the exercise:

  • Provide pacing support in the event of AV block during exercise

FULL DIAGNOSTICS WITH EGMs

  • Records episodes of AV block with EGM A & V​

  • Provides an accurate AVB degree diagnosis / classification allowing for optimized patient treatment

  • Data analysis and suggestions

HOW DOES IT WORK

SafeR™ pacing mode has been designed to promote the natural atrioventricular (AV) conduction and minimize the unnecessary right ventricular pacing.​

  • SafeR™ provides AAI pacing while continuously monitoring AV conduction​

  • It ensures DDD pacing when needed for ALL types of AV blocks,  at rest and exercise​

  • Switches back to AAI mode when needed

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SAFER™​ MODE SWITCHES

Switch criteria from AAI to DDD mode

2 CONSECUTIVE BLOCKED ATRIAL EVENTS

AAI to DDD

3 BLOCKED ATRIAL EVENTS / 12 CONSECUTIVE CYCLES

AAI to DDD

6 CONSECUTIVE LONG PR INTERVALS

AAI to DDD

VENTRICULAR PAUSE OF 2.3 OR 4 SECONDS (PROGRAMMABLE)

AAI to DDD

Switch criteria from DDD to AAI mode

12 CONSECUTIVE SENSED R WAVES

DDD to AAI

EVERY 100 PACED CYCLES

DDD to AAI

EVERY MORNING AT 8:00 AM

DDD to AAI

CLINICAL EVIDENCE

The ANSWER study is a randomized controlled multicentre trial assessing SafeR™ mode versus standard DDD mode in sinus node disease (SND) or AV block (AVB) patients. ANSWER enrolled 650 patients (52.0% SND, 48% AVB) at 43 European centers and randomized in SafeR™.

THE ANSWER STUDY

Long-term clinical effects of ventricular pacing reduction with a changeover mode to minimize ventricular pacing in a general pacemaker population

THE ANSWER TRIAL SUB-STUDY

Safety and efficiency of ventricular pacing prevention with an AAI-DDD changeover mode in patients with sinus node disease or atrioventricular block: impact on battery longevity— a sub-study of the ANSWER trial

INSIGHTS FROM HEALTHCARE PROFESSIONALS

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SafeR™ Technology - A Crucial Role in Reducing Ventricular Pacing for Cardiovascular Health

To gain deeper insights into Dr. Castro's professional perspective and witness the transformative capabilities of SafeR™

SafeR™ Technology - Personalized and Adaptive Care Solutions for All Patients

Listen to Dr. Daux's perspectives on SafeR™ technology and its potential impact on personalized patient care

SafeR™ Technology - Optimal Care with Diagnostic Precision

Delve deeper into Dr. Catalan's insights and grasp the nuances of SafeR™ Technology

SafeR™ Technology - Clinically Proven Long-Term Effectiveness and Safety

Listen to Prof. Oliveira's extensive experience and the profound impact of the SafeR™ algorithm

SafeR™ Technology - 20 Years of Cardiovascular Innovation

Join us as we celebrate 20 years of success and innovation of SafeR™ Technology

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