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Reply 200

Catalogue: Outside USA

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Reply 200 is the world’s smallest pacemaker1 and the market leader in reliability2

Featuring:

  • Sleep Apnea Monitoring - Sleep Apnea Monitoring measures respiration pauses and reduction in respiration.
  • SafeR - Designed to promote intrinsic conduction in patients who need dual-chamber pacing3.

Reply 200 pacemakers extend the boundaries in cardiovascular disease management, providing the ideal combination of small size1, longevity4 and high performance.2

 

REferences

  1. REPLY DR Competitive Summary, Sorin Group, ULS4222C, October 2013.
  2. Sorin Group Product Performance Report, May 2014.
  3. M. Stockburger, S. Boveda, P. Defaye, J. Moreno on behalf of the ANSWER Investigators. Evaluation of the SafeR Mode in patients with a dual chamber pacemaker indication (ANSWER): Long-term clinical outcome results of the ANSWER trial. European Heart Journal.2014 September.
  4. REPLY 200 DR with typical conditions using SafeR: 50% A pacing, 5% V pacing, SAM ON, 60ppm, 2.5V, 0.35ms, 750 ohms, EGM & Diagnostics on, Rate response on, Sensors on. REPLY 200 SR, 11.4 years of longevity in 7.5cc only with conditions: 100% V pacing, SAM ON, 60ppm, 2.5V, 0.35ms, 750 ohms, EGM & Diagnostics on, Rate response on, Sensors on.

This product is not available for sale or distribution in the USA. For further information on product availability, please contact your local representative

Features

SLEEP APNEA MONITORING

Our Sleep apnea monitoring algorithm (SAM) measures respiration pauses and reductions.

  • Uses an MV sensor
  • Provides reliable, automatic screening to detect severe sleep apnea with high specificity (85%) and high sensitivity (89%)1
  • Designed to detect, to count and to report abnormal breathing events during the night2

Sleep apnea monitoring is available in Reply 200 SR and DR.

 

VALIDATED RESPIRATORY DISTURBANCE INDEX

  • Based on 20 years of experience with the minute ventilation sensor
  • Measured every night from 00:00 to 05:00 (programmable)2
  • Validated against gold standard AHI* (polysomnography)1

*Apnea/hypopnea index = number of events/number of hours of sleep

 


RELIABLE SCREENING FOR SEVERE SLEEP APNEA

  • Automatic messages about abnormal breathing events are detected by the device
  • Allows for short and efficient follow up
  • A severity threshold is used to indicate the risk of severe sleep apnea syndrome2**

**Depending on the patient profile and/or other symptoms, the physician may engage in dialogue with the patient and include a neurologist or a sleep specialist, as appropriate.

 

Designed to detect, count, and report abnormal breathing events during the night

  • 6 month trend of RDI during follow-up2

  • AF burden shown in parallel2***

Intelligent management of AV conduction

Uncessary Rv pacing icreases the risk of AF and HF Hospitalization3,4,5,6,7

SafeR ***

  • Nearly eliminates ventricular pacing8
  • Adds 2 years of device longevity9
  • Manages all AV blocks10

SafeR was recently shown to be as safe and effective in AVB patients as in SND patients10,11

***Reply 200 DR only


REFERENCES

  1. Defaye P, de la Cruz I, Martí-Almor J et al. A pacemaker transthoracic impedance sensor with an advanced algorithm to identify severe sleep apnea: The DREAM European study. Heart Rhythm 2014;11:842-8.
  2. Sorin REPLY 200 Implant Manual (U071A Reply 200 DR / U072A Reply 200 SR) – available at http://www.sorinmanuals.com.
  3. Andersen HR, Nielsen JC, Thomsen PE, et al. Long-term follow-up of patients from a randomized trial of atrial versus

    ventricular pacing for sick-sinus syndrome. Lancet. 1997;350:1210-6.

  4. Skanes AC, Krahn AD, Yee R, et al, for the CTOPP Investigators. Progression to chronic atrial fibrillation after pacing:

    The Canadian Trial Of Physiologic Pacing. J Am Coll Cardiol. 2001;38:167-72.

  5. Nielsen J, Kristensen L, Andersen H, et al. A randomized comparison of atrial and dual chamber pacing in 177

    consecutive patients with sick sinus syndrome. J Am Coll Cardiol. 2003;42:614-23.

  6. Sweeney M, Hellkamp A, Ellenbogen K, et al. Adverse effect of ventricular pacing on heart failure and atrial

    fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node

    dysfunction. Circulation. 2003;107:2932-37.

  7. Wilkoff BL, Cook JR, Epstein AE, et al. Dual-chamber pacing or ventricular backup pacing in patients with an

    implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002;288:3115–23.

  8. Davy JM, Hoffmann E, Frey A et al. Near elimination of ventricular pacing in SafeR mode compared to DDD modes: a randomized study of 422 patients. Pacing Clin Electrophysiol 2012; 35:392-402.
  9. Benkemoun H, Sacrez J, Lagrange P et al. Optimizing pacemaker longevity with pacing mode and settings programming: results from a pacemaker multicenter registry. Pacing Clin Electrophysiol 2012; 35:403-408.
  10. M. Stockburger, S. Boveda, P. Defaye, J. Moreno on behalf of the ANSWER Investigators. Evaluation of the SafeR Mode in patients with a dual chamber pacemaker indication (ANSWER): Long-term clinical outcome results of the ANSWER trial. European Heart Journal.2014 September.
  11. Thibault B et al., 2009, Impact of AV Conduction Disorders on SafeR Mode Performance: CAN-SAVER a Canadian Multi-Center Study, PACE 2009, Volume 32, Issue Supplement s1, pages S231–S235.

 

Evidence

The ideal combination of small size, longevity and performance: 12 years longevity in only 8cc.1,2

Reply 200 is built on the Reply platform.3

 

References

  1. REPLY DR Competitive Summary, Sorin Group, ULS45222A, April 2012
  2. REPLY 200 DR with typical conditions using SafeR: 50% A pacing, 5% V pacing, SAM ON, 60ppm, 2.5V, 0.35ms, 750 ohms, EGM & Diagnostics on, Rate response on, Sensors on. REPLY 200 SR, 11.4 years of longevity in 7.5cc only with conditions: 100% V pacing, SAM ON, 60ppm, 2.5V, 0.35ms, 750 ohms, EGM & Diagnostics on, Rate response on, Sensors on.
  3. Sorin Group Product Performance Report, May 2014.

 

This product may not be for sale in your country or your area. For further information on product availability, please contact your local representative

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