PARADYM RF SONR CRT-D

Catalogue: Outside USA

20_det_paradym_rf_sonr_C_v1.jpg

The PARADYM RF SONR CRT-D has self-adjusting technology that thinks like you

  • SonR technology is the only CRT System to provide heart failure patients with automatic and frequent hemodynamic CRT optimization both at rest and exercise. SonR provides a 23% improvement in CRT response1
  • PARAD+ Analyzes arrhythmias as an electrophysiologist would
  • BTO (Brady-Tachy Overlap) ensures pacing at exercise rate while allowing for unmatched accuracy for slow VT discrimination2,3
  • Smartview remote monitoring makes follow-up easy, allowing for faster decision making from reports that are focused and that contain fewer and more relevant alerts

 

References

  1. Ritter P, Delmoy PP, Padelletti L, ey al. Randomized Pilot Study of Optimization of Cardiac Resynchronization Therapy in Sinus Rhythm Patients Using a Peak Acceleration Sensor vs. Standard Methods. Eurpace 2012; 14(9): 1324-33. (CLEAR pilot study is randomized study to optimize patients either automatically by PEA (SonR 1st generation) based method of according to centers usual practices(control group)).
  2. Anselme F, Mletzko R, Bowes R, et al. Prevention of Inappropriate Shocks in ICD Recipients: A review of 10,000 tachycardia episodes. PACE 2007; 30:S128-33.
  3. Sadoul N, Mletzko R, Anselme F, et al. Incidence and clinical relevance of slow ventricular tachycardia in implantable cardioverter-defibrillator recipients: an international multicenter prospective study. Circulation 2005;112:946-53

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

Features

Frequent Hemodynamic CRT optimization with SonR.

SonR technology is the only CRT System to provide heart failure patients with automatic and frequent hemodynamic CRT optimization both at rest and exercise. SonR provides a 23% improvement in CRT response1

SonR uses a unique hemodynamic sensor

The unique sensor embedded in the tip of the SonRtip atrial sensing/pacing lead detects cardiac muscle vibrations that correlate to left ventricular (LV) dP/dtmax 2-4 .

PARAD+ analyzes arrhythmias as an electrophysiologist would.

Protects patients with best-in-class 99% SVT specificity5

  • Only 2.6% of patients received inappropriate shocks at 1 year with PARAD+ out of the box settings6

Efficient Resynchronization for active patients with BTO (Brady-Tachy Overlap)

BTO ensures pacing at exercise rate while allowing unmatched accuracy for slow VT discrimination7.8

  • Allows patients to be paced in the slow VT zone to favor exercise. Exercise training is part of the treatment of HF patients, reducing mortality and improving QoL9,10

Faster decisions from focused reports with Smartview Remote Monitoring

martview remote monitoring generates reports that take you instantly to the heart of therapy.

  • Important clinical insights are presented first
  • All transmissions come with IEGM and full follow-up

Alerts organized according to the level of severity

  • High PARAD+ specificity minimizes irrelevant alerts

Supported by a dedicated help desk


References

  1. Ritter P, Delmoy PP, Padelletti L, ey al. Randomized Pilot Study of Optimization of Cardiac Resynchronization Therapy in Sinus Rhythm Patients Using a Peak Acceleration Sensor vs. Standard Methods. Eurpace 2012; 14(9): 1324-33. (CLEAR pilot study is randomized study to optimize patients either automatically by PEA (SonR 1st generation) based method of according to centers usual practices(control group)).
  2. Rickards AF, Bombardini T, Corbucci G, et al. An implantable intracardiac accelerometer for monitoring myocardial contractility. The Multicenter PEA Study Group. Pacing Clin Electrophysiol 1996;19:2066-2071.
  3. Bongiorni MG, Soldati E, Arena G, et al. Is local myocardial contractility related to endocardial acceleration signals detected by a transvenous pacing lead. Pacing Clin Electrophysiol 1996;19:1682-1688.
  4. Bordachar P, Labrousse L, Ploux S, et al. Validation of a new noninvasive device for the monitoring of peak endocardial acceleration in pigs: implications for optimization of pacing site and configuration. J Cardiovasc Electrophysiol 2008;19(7):725-729.
  5. Hintringer F, Deibl M, Berger T, Pachinger O, Roithinger FX. Comparison of the specificity of implantable dual chamber defibrillator detection algorithms. PACE 2004; 27:976-82.
  6. Option study – Late breaking trials – Europace 2013 – Sorin data on file
  7.  Anselme F, Mletzko R, Bowes R, et al. Prevention of Inappropriate Shocks in ICD Recipients: A review of 10,000 tachycardia episodes. PACE 2007; 30:S128-33.
  8. Sadoul N, Mletzko R, Anselme F, et al. Incidence and clinical relevance of slow ventricular tachycardia in implantable cardioverter-defibrillator recipients: an international multicenter prospective study. Circulation 2005;112:946-53.
  9. Hunt SA,et al. ACC/AHA 2005 Guideline Update  for the Diagnosis and Management of Chronic Heart Failure in the Adult. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2005; 112:e154-e235.
  10. Swedberg, et al. Guidelines for the diagnosis and treatment of chronic heart failure: executive summary (update 2005): The Task Force for the Diagnosis and Treatment of Chronic Heart Failure of the European Society of Cardiology. Eur Heart J 2005; 26; 1115-1140

 

Evidence

SonR: a 23% improvement in CRT response

In the CLEAR study, 76% of patients in the SonR arm compared with 62% in the standard medical practice arm improved, using the primary composite endpoints of death, heart failure (HF)-related hospitalizations, NYHA class, and quality of life (QoL)1.

 


Fewer deaths and hospitalizations

Frequent hemodynamic optimization of AV and VV delays is associated with fewer deaths and hospitalizations2.

  • 54.4% risk reduction in all cause mortality and HF hospitalization

 

Patients systematically optimized either by SonR or echo (Group 1) compared to non-systematically optimized patients (Group 2).

 


REFERENCES

  1. Ritter P, Delnoy PP, Padeletti L, et al. A randomized pilot study of optimization of cardiac resynchronization therapy in sinus rhythm patients using a peak acceleration sensor vs. standard methods. Europace 2012; 14(9):1324-33. [CLEAR pilot study is a randomized study to optimize patients either automatically by PEA (SonR 1st generation) based method or according to the center’s usual practices (control group)].
  2. Delnoy PP, Ritter P, Naegele H, et al. Association between frequent cardiac resynchronization therapy optimization and long-term clinical response: a post hoc analysis of the Clinical Evaluation on Advanced Resynchronization pilot study. Europace 2013;15(8):1174-81.

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