Product Details

Models D320, D321, D332, D333

• ENDURALIFE™ battery technology projected to last up to 17.5 years for VR devices and 16.0 years for DR devices.*
• This small (29.5 cc) and thin (9.9 mm) high-energy device is designed to enhance patient comfort.
• IMAGEREADY™ MR-Conditional Systems allow patients to receive full body MR-Conditional scans at 1.5T or 3T without exclusion zone, scan duration, or patient height restrictions.**
• Atrial Arrhythmia Report provides a comprehensive view of your patient’s AT/AF status and information for assessing AFtreatment efficacy.
• The PaceSafe™ RV, RA, and LV auto threshold feature is designed to maintain adequate output safety margins.
• Offers AcuShock™ Advanced Technology, multiple programmable options to reduce inappropriate and unnecessary shocks,including a choice of rhythm discriminators, RhythmID™ with RhythmMatch™ (customization of Rhythm ID algorithm),antitachycardia pacing (ATP) therapy in all rates zones, and advanced sensing and filtering.
• Wireless ECG saves time and simplifies follow-up.
• EasyView™ header and color coded lead ports designed to make the implant experience more efficient.
• SafetyCore™ technology is intended to provide lifesaving shock therapy and basic pacing functionality in the event of an unrecoverable fault.

* 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.

Mechanical Specifications

Longevity Information

Pulse Generator Longevity (All Models a,b,c,d,e,f)

EnduraLife Battery Technology provides clinically proven, industry-leading projected longevity2-10. The following tables represent example pulse generator life expectancy estimation (implant to explant) 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.

Additional Longevity Information

• Warranty information available at www.bostonscientific.com/warranty
• Devices use Li/MnO2 chemistry.
• The Usable Battery Capacity is 1.8 Amp-hours (typical implant to battery capacity depleted).
• Shelf life is 2 years (before use by).

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References:

a. Assumes 60 min-1 LRL, 0.4 ms pacing pulse width; sensors On, Heart Failure Sensor Suite On.
b. 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.
c. PaceSafe On for RAAT and RVAT provides an output of 2X the threshold with a minimum output of 2.0 V.
d. Assumes ZIP telemetry use for 1 hour at implant and for 40 minutes annually for in-clinic follow-up checks.
e. Assumes standard use of the LATITUDE™ Communicator as follows: Daily Device Check on, quarterly scheduled remote follow ups, and other typical interrogations.
f. Assumes LATITUDE™ Communicator is not used, Minute Ventilation (MV)/Respiratory Sensor is Off, and Heart Failure Sensor Suite is Off.
1. 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;3:176–180. Refer to the Physician’s System Guide for more information on adaptive-rate therapy. Additional clinical performance was assessed using INSIGNIA™ Ultra clinical data with the AutoLifestyle™ feature programmed On. Boston Scientific. Data on file. ALTRUA™ Pacemaker System Guide. 2008;1:20–25.monthly Full Interrogations (scheduled remote follow ups, and quarterly patient-interrogations). 2. Nine independent studies confirm that CRT-Ds powered by EnduraLife Battery Technology offer industry-leading longevity.
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 longegity 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 repleacements 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.

CAUTION: The law restricts this device to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Information not intended for use or distribution in France.

CAUTION: The law restricts this device to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Information not intended for use or distribution in France.