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RESONATE™ Implantable Cardiac Defibrillator (ICD)

RESONATE™ Implantable Cardiac Defibrillator (ICD)

RESONATE™ HF and RESONATE™ EL transvenous implantable cardioverter defibrillators (ICDs) deliver more shocks and shock polarity options, providing increased protection against sudden cardiac death. RESONATE ICDs feature RightRate™ Minute Ventilation (MV) for physiologic rate-response, advanced atrial arrythmia diagnostics, RYTHMIQ™ pacing algorithm, HeartLogic™ heart failure diagnostic, and EnduraLife™ Battery Technology for industry-leading longevity without compromises.
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Overview

RightRate Minute Ventilation

The only sensor clinically proven to restore chronotropic competence and maintain healthy heart rate variability.1 Available only with RESONATE HF ICD.

HeartLogic heart failure diagnostic

HeartLogic uses multiple sensors to track physiological trends, combines them into one composite index and sends a proactive alert of a potential heart failure event weeks in advance.2

EnduraLife Battery Technology

Enjoy up to 13.2 years projected longevity with RightRate, LATITUDE™ and Heart Failure Sensor Suite turned on.*

ImageReady MR-Conditional Systems

Your patients can safely undergo Full Body MRI scans with ImageReady MR-Conditional Systems.**

Longevity Information

Pulse Generator Longevity (All Models)

EnduraLife Battery Technology provides clinically proven, industry-leading projected longevity3-11. The following tables represent sample pulse generator life expectancy estimation (implant to explant) with EnduraLife battery as provided in product labeling. For specific programmable parameter ranges, refer to product labeling at www.bostonscientific.com/manuals, or contact Boston Scientific technical services or your local representative.

 


Projected Longevitya
TypePacing AmplitudePacing500Ω with
LATITUDEb		700Ω with LATITUDEb900Ω with LATITUDEb700Ω no LATITUDE, RS, or HFSSc
VR
Typical programmed settingVR2.5 V15%15.015.115.217.1
Maximum labeled longevityVR2.0 V / Off0%15.415.415.417.5
DR
Typical programmed settingDR2.5 V15%13.613.713.815.4
Maximum labeled longevityDR2.0 V0%14.214.214.216.0
  • Assumes 70 PPM LRL; DDDR mode; 0.4 ms Pulse Width (RA, RV); sensors On, Heart Failure Sensor Suite On.
  • Projected longevity is calculated assuming 2 maximum energy charging cycles per year, including automatic capacitor re-forms and therapeutic shocks. These calculations also assume 3-channel EGM Onset is on and that the pulse generator spends 3 months in Storage mode during shipping and storage.

a. Assumes ZIP telemetry use for 2 hours at implant and for 40 minutes annually for in-clinic follow-up checks.

b. Assumes standard use of the LATITUDE™ Communicator as follows: Daily Device Check on, quarterly scheduled remote follow ups, and other typical interrogations.

c. Assumes LATITUDE™ Communicator is not used, Respiratory Sensor is Off, and Heart Failure Sensor Suite is Off.

Additional Longevity Information

  • Boston Scientific devices have corporate warranties at 10 years (VR) and 8 years (DR) in available geographies. Warranty information available at www.bostonscientific.com/warranty.
  • Devices use Li/MnO2 chemistry.
  • The Usable Battery Capacity is 1.9 Amp-hours (typical implant to battery capacity depleted).
  • Shelf life is 2 years (before use by).

Technical specifications

ModelTypeSize (cm)
(W x H x D)		Mass
(g)		Volume
(cc)		Connector Type
(RA RV LV)		C-Codes
D532VR5.37 x 7.36 x 0.9968.929.5RV: DF4C-1722
D533DR5.37 x 7.68 x 0.9971.431.0RA: IS-1; RV: DF4C-1721
D432VR5.37 x 7.36 x 0.9968.929.5RV: DF4 
D433DR5.37 x 7.68 x 0.9971.431.0RA: IS-1; RV: DF4 

References

* Assumes: 2.0V RA, 2.0V RV, 0% pacing, 700Ω, No LATITUDE, No Respiratory Rate Sensor, No Heart Failure Sensor Suite.

** When conditions of use are met.

  1. Boehmer JP, Hariharan R, Devecchi FG, et al. A Multisensor algorithm predicts heart failure events in patients with implanted devices: resultsfrom the MultiSENSE study. JACC Heart Fail. 2017 Mar;5(3):216-25.
  2. Chronotropic competence is defined by the Model of the Cardiac Chronotropic Response to Exercise. Wilkoff B, Corey J, Blackburn G. A mathematical model of the cardiac chronotropic response to exercise. Journal of Electrophysiology. 1989;3:1.
  3. Haarbo J, Hjortshoj S, Johansen J, Jorgensen O, Nielsen J, Petersen H. Device Longevity in Cardiac Resynchronization Therapy Implantable Cardioverter Defibrillators Differs Between Manufacturers: Data from the Danish ICD Registry. Presented at HRS 2014. https://ondemand.hrsonline.org/common/presentation-detail.aspx/15/35/1241/9000. Boston Scientific = 136 patients, Medtronic = 651 patients, St. Jude Medical = 1,587 patients, Bitronik = 369 patients. Time to exchange of the device because of battery depletion or device failure recorded in the Danish ICD Registry was the endpoint. The four-year survival rate for devices in the Danish Registry study was 81.1% for Medtronic and 95.7% for Boston Scientific (P<0.01).
  4. J. Williams, R. Stevenson. Contemporary cardiac resynchronization implantable cardioverter defibrillator battery longevity in a community hospital heart failure cohort. Presented at HFSA 2014. https://www.onlinejcf.com/article/. S1071-9164 (14)00389-3/fulltext. Boston Scientific = 53 patients, Medtronic = 28 patients, St. Jude Medical = 10 patients. Four-year survival rate calculated using device replacements for battery depletion as indicated by ERI.
  5. Ellis CR, Dickerman DI, Orton JM, Hassan S, Good EG, Okabe T, Andruilli JA, Quan KJ, Greenspoon AJ. Ampere Hour as a Predictor of Cardiac Resynchronization Defibrillator Pulse Generator Battery Longevity: A Multicenter Study. PACE 2016 doi: 10.1111/pace.12831 first published online 11-MAR-2016. The five major institutions performing the study include, at Vanderbilt University, Henry Ford Hospital, University of Michigan, Thomas Jefferson University, Cooper Health System, North Ohio Heart Center. Boston Scientific = 322 patients, Medtronic = 794 patients, St. Jude Medical = 186 patients. Five-year survival rate calculated using device replacements for battery depletion as indicated by ERI.
  6. Landolina M, Curnis A, Morani G, Vado A, Ammendola E, D’onofrio A, Stabile G, Crostao M, Petracci B, Ceriotti C, Bontempi L, Morosato M, Ballari GP, Gasparini M. Longevity of implant Cardioverter-defibrillators for cardiacresynchronization therapy in current clinical practice: an analysis according to influencing factors, device generation, and manufacturer. Europace2015; 17:1251-58.doi:10.1093/eurospace/euv109. First published online: May 14, 2015. Medtronic = 532 patients, Boston Scientific = 291 patients, St. Jude Medical = 106 patients, Biotronik = 20 patients, Sorin = 69. Five-year survival rate of latest marketed devices (between 2006 and 2010) calculated using device replacements for battery depletion as indicated by ERI.
  7. Zanon F, Martignani C, Ammendola E, Menardi E, NarducciML, De Filippo P, Santamaria M, Campana A, Stabile G, Potenza DR, Pastore G, lori M, La Rosa C, and Biffi M. Device Longevity in a Contemporary Cohort of ICD/CRT-D Patients Undergoing Device Replacement. Doi:10.1111/jce.12990, First published online 20-APR-2016. Comparison of device longevity by Kaplan-Meier curves of CRT-D systems extracted between March 2013 and May 2015. Medtronic = 195 patients, Boston Scientific = 157 patients, St. Jude = 72, Biotronik = 9.
  8. Provided by Dr. Ernest Lau on 04/29/15 in support of Lau E, Wilson C, Ashfield K, McNair W, McEneany D, Roberts M, Large Capacity LiMn02 Batteries Extended CRTD Longevity in Clinical Use Compared to Smaller Capacity LiSVO Batteries Over 6 Years. Presented at HRS 2015. Medtronic = 62 patients, Boston Scientific = 27 patients, St. Jude = 66 patients. Five-year survival rate calculated using device replacements for battery depletion as indicated by ERI.
  9. Von Gunten S, Schaer BA, Yap SC, Szili-Torok T, Kühne M, Sticherling C, Osswald S, Theuns DA. Longevity of implantable cardioverter defibrillators: a comparison among manufacturers and over time. Europace. 2015 Nov 25. Epub 2015 Nov 25. Total patients = 3436.
  10. Alam MB, Munir MB, Rattan R, Adelstein E, Jain S, Saba S. Battery longevity from cardiac resynchronization therapy defibrillators: differences between manufacturers and discrepancies with published product performance reports. Europace 016;doi:10.1093/europace/euw044. First published online: 22-MAR-2016. Kaplan Meier curves depicting survival of CRT devices free from battery depletion by device manufacturer. Battery Longevity in Cardiac Medtronic = 416 patients, Boston Scientific = 173 patients, St. Jude Medical = 57 patients. Previously evaluated these patients at a four-year survival rate calculated using device replacements for battery depletion as indicated by ERI. 2014; Europace (2014) 16,246-51.
  11. Shabanna Din, Shabanna, Mcgee, Rao, Archana, Wright, Jay D. Longevity of implantable cardioverter defibrillators: The impact of device manufacturer and device type on device longevity were assessed. Europace. 2015 Nov 25; Epub 2015 Nov 25. Total patients = 3436. Cardiostim Abstract 2016. Total patients = 1489.