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MORE OPTIONS TO MAKE NON-RESPONSE A NON-ISSUE

The Quadra Assura MP™ CRT-D brings MultiPoint™ Pacing, an exclusive Abbott technology, to cardiac resynchronization therapy defibrillators (CRT-Ds).

 

MultiPoint Pacing technology is designed to deliver multiple independent left ventricular (LV) pacing pulses from a single quadripolar lead to provide you with CRT options to change:

  • Pattern of depolarization
  • Engagement of areas around scar tissue
  • Hemodynamics
  • Resynchronization

The Quadra Assura MP™ CRT-D with Quartet™ quadripolar LV pacing lead, with its four pacing electrodes and 10 pacing vectors, provides more options and greater control in CRT response.

U.S. IDE STUDY: IMPORTANCE OF MULTIPOINT™ PACING TECHNOLOGY PROGRAMMING1

The recent IDE study1 post-hoc subanalysis (n = 199) showed that wider cathode spacing and near-simultaneous intraventricular timing delays provide best MultiPoint Pacing technology response at 87 percent and “super-response” at 54 percent (52 patients).1

Learn more:

Additional International Clinical Data

This evidence builds on our quadripolar standard of care, which has offered you more options to pace at the preferred LV site, resulting in:

  • Improved CRT outcome2,3
  • Fewer surgical revisions4
  • Reduced need for lead repositioning at implant, leading to shorter procedure times and decreased fluoroscopic exposure5,6
  • More basal pacing opportunities without compromising lead stability7,8

QUADRA ASSURA MP CRT-D ADVANCED FEATURES AND BENEFITS

Now MRI Ready

The Quadra Assura MP CRT-D is MR conditional when used with specific leads and lead lengths, and allows full-body, 1.5T MRI scans that meet certain scan conditions.*

  • Meets industry-standard MRI testing requirements
  • Capable of full body 1.5T MRI imaging scans
Designed to Optimize Tissue Selection

The Quadra Assura MP RF CRT-D offers Auto VectSelect Quartet™ Test that:

  • Automatically identifies tissue sites with the latest activation via RV-LV conduction delays measurements
  • Performs threshold testing, assesses LVCap™ Confirm applicability and enables marking of PNS

Pacing at the tissue site of latest activation improves:

  • Acute hemodynamic response9
  • Reverse remodeling10
  • Quality of life10
Enhanced Programming Options
  • SyncAV™ CRT technology automatically adjusts pacing based on real-time changes in a patient's cardiac condition.
  • Antitachycardia pacing (ATP) while charging and prior to charging in the VF zone further extends the programming options for terminating tachyarrhythmias without a high-voltage shock.
  • SenseAbility™ feature provides flexibility to fine-tune programming around T-wave oversensing without decreasing sensitivity.
Additional Monitoring and Safety Features
  • ShockGuard™ technology with DecisionTx™ programming
  • SecureSense™ RV lead noise discrimination
  • Far Field MD™ morphology discrimination
  • DeFT Response™ technology
  • CorVue™ congestion monitoring feature
  • QuickOpt™ timing cycle optimization
BUILDING COMPREHENSIVE HEART FAILURE MANAGEMENT

The Quadra Assura MP™ CRT-D Is one of our heart failure management therapies. Our vision is to transform the treatment of heart failure by designing technology that delivers excellent clinical outcomes and improves workflow and efficiency. Read more about our approach to heart failure management.

RESOURCES AND DOCUMENTATION

REFERENCES

*See MRI Ready Systems Manual for device and lead combinations and associated MRI scan parameters.
1. Niazi, I., Baker, J., Corbisiero, R., Love, C., Martin, D., Sheppard, R., ... Tomassoni, G., & MPP Investigators. (2017). Safety and efficacy of Multipoint pacing in cardiac resynchronization therapy: The MultiPoint pacing trial. JACC: Clinical Electrophysiology, 3 (13), 1510-1518. https://doi.org/10.1016/j.jacep.2017.06.022
2. Forleo,. G. B., Mantica, M., Di Biase, L., Panattoni, G., Della Rocca, D. G., Papavasileiou, L. P., … Romeo, F. (2012). Clinical and procedural outcome of patients implanted with a quadripolar left ventricular lead: Early results of a prospective multicenter study. Heart Rhythm, 9(11), 1822-1828. http://dx.doi.org/10.1016/j.hrthm.2012.07.012
3. Turakhia, M., Cao, M., Fischer, A., Arnold, E. M., Sloman, L. S., Dalal, N., & Gold, M. (2014, June). Reduced mortality with quadripolar compared to bipolar left ventricular leads in cardiac resynchronization therapy. Presented at the World Congress in Cardiac Electrophysiology and Cardiac Techniques, Nice, France. Retrospective analysis; not prespecified.
4. Forleo, G. B., Della Rocca, D. G., Papavasileiou, L. P., Molfetta, A. D., Santini, L., & Romeo, F. (2011). Left ventricular pacing with a new quadripolar transvenous lead for CRT: Early results of a prospective comparison with conventional implant outcomes. Heart Rhythm, 8(1), 31-37. http://dx.doi.org/10.1016/j.hrthm.2010.09.076
5. Dänschel, W., Sperzel, J. K., Gutleben, K., Kranig, W., Mortensen, P., Connelly, D., … Hallier, B. (2010). Initial clinical experience with a novel left ventricular quadripolar lead. Europace, 12(Suppl. 1), i127. http://dx.doi.org/10.1093/europace/euq127
6. Duray, G. Z., Hohnloser, S. H., Israel, C. W. (2008). Coronary sinus side branches for cardiac resynchronization therapy: prospective evaluation of availability, implant success, and procedural determinants. Journal of Cardiovascular Electrophysiology,19(5), 489-494. http://dx.doi.org/10.1111/j.1540-8167.2007.01096.x
7. Merchant, F. M., Heist, E. K., McCarty, D., Kumar, P., Das, S., Blendea, D., … Singh, J. P. (2010). Impact of segmental left ventricular lead position on cardiac resynchronization therapy outcomes. Heart Rhythm, 7(5), 639-644. http://dx.doi.org/10.1016/j.htrhtm.2010.01.035
8. Singh, J. P., Klein, H. U., Huang, D. T., Reek, S., Kuniss, M., Quesada, A., … Moss, A. J. (2011). Left ventricular lead position and clinical outcome in the Multicenter Automatic Defibrillator Implantation Trial Cardiac Resynchronization Therapy (MADIT-CRT) trial. Circulation, 123(11), 1159-1166.http://dx.doi.org/10.1161/CIRCULATIONAHA.110.000646
9. Yu, Y., Auricchio, A., Butter, C., Stellbrink, C., Vogt, J., Goehring, A., & Spinelli, J. (2002). Assessment of resynchronization effectiveness of left ventricular lead site. Journal of Cardiac Failure, 8(4S), S72.
10. Gold, M., Birgersdotter-Green, U., Singh J., Ellenbogen, K., Yu, Y., Meyer, T., …Tchou, P. (2011).The relationship between ventricular electrical delay and left ventricular remodeling with cardiac resynchronization therapy. European Heart Journal, 32(20), 2516-2524. http://dx.doi.org/10.1093/eurheartj/ehr329

A GROWING BODY OF EVIDENCE FOR MULTIPOINT™ PACING
THE U.S. IDE STUDY
Meeting Safety and Efficacy Endpoints1

The recent MultiPoint™ Pacing U.S. IDE study from Tomassoni et al. showed:

  •  Safety: 93.2% freedom from system-related complications1
  •  Efficacy: MultiPoint™ Pacing technology demonstrated to be noninferior to BiV with respect to non-responder rate1
Converting Non-Responders To Responders1

The subanalysis study demonstrated that wider cathode spacing and near-simultaneous intraventricular timing delays are best. When MultiPoint™ Pacing technology was programmed with cathode spacing ≥ 30 mm and 5 ms LV delay:

  • CRT response rate was greatest at 87% and the super-responder rate was greatest at 54% (n = 52)1
  • Non-responders were converted to responders (8 of 8 patients)1

Conclusions from the U.S. IDE study include:

  • MultiPoint™ Pacing technology is safe and effective1
  • The enrolled patient population had a high response rate to quadripolar BiV pacing1
  • MultiPoint™ Pacing technology response rates for this patient population are greatest when devices are programmed with wide LV electrode spacing and short intraventricular delay1
  • There is a growing body of evidence that MultiPoint™ Pacing is a feature that physicians can use to potentially improve responder rates1
Responder vs nonresponder graph

Read through the abstract for the published paper on the U.S. MultiPoint™ Pacing IDE study.

MULTIPOINT PACING DATA FROM INTERNATIONAL STUDIES

Several international studies report results related to improved patient response to CRT with MultiPoint Pacing as compared to single-site pacing.

Reported Improvements Of CRT Response Rate At 12 Months2

Zanon et al. compared 20 patients optimized with MultiPoint Pacing to 36 patients optimized with traditional BiV pacing and 54 nonoptimized BiV patients.2 The results indicate a progression in response from nonoptimized BiV to optimized BiV to optimized with MultiPoint Pacing at 12 months consistently measured over three definitions of response:

  • 90% response rate with MultiPoint™ Pacing measured by ESV decrease > 15%2
  • 95% response rate with MultiPoint™ Pacing measured by ≥ 1 decrease in NYHA class2
  • 90% response rate with MultiPoint™ Pacing measured by Packer’s score2
MPP tech 1 year data

ΔESVi, ΔNYHA, and PACKER’S response rates. Response indicates ΔESVi ≥ 15%, ΔNYHA Class > 0, or PACKER’S score = 0 at follow-up relative to baseline. The vertical segments represent the 95 percent CI of the estimated proportions.

Reported Improvements In Ejection Fraction At 6 Months3

Forleo et al. compared the changes in ejection fraction (EF) in 232 patients with a 6-month follow-up.3 During implant, capture thresholds were measured as well as the presence of PNS. The results show:

  • MultiPoint™ Pacing technology was programmable in 97% of patients3
  • 56% clinical composite score for patients with MultiPoint Pacing technology turned on versus 38% in control group3
  • 39% ± 9.6% increase from 28.2% ± 509 in left ventricular EF for patients with MultiPoint Pacing technology turned on3
  • 34.6% ± 7.6% increase from 28.1% ± 6.0 in patients with MultiPoint Pacing technology turned off3
MPP registry

In summary, the Italian MultiPoint Pacing technology registry (IRON-MPP) study showed QRS was reduced and both EF and clinical composite score improved with MultiPoint Pacing technology relative to conventional BiV.3

BUILDING COMPREHENSIVE HEART FAILURE MANAGEMENT

The Quadra Assura MP™ CRT-D Is one of our heart failure management therapies. Our vision is to transform the treatment of heart failure by designing technology that delivers excellent clinical outcomes and improves workflow and efficiency. Read more about our approach to heart failure management.

 

RESOURCES AND DOCUMENTATION

PRODUCT MANUALS (INSTRUCTIONS FOR USE)

REIMBURSEMENT INFORMATION

REFERENCES

1. Niazi, I., Baker, J., Corbisiero, R., Love, C., Martin, D., Sheppard, R., ... Tomassoni, G., & MPP Investigators. (2017). Safety and efficacy of Multipoint Pacing in cardiac resynchronization therapy: The MultiPoint pacing trial. JACC: Clinical Electrophysiology, 3 (13), 1510-1518. https://doi.org/10.1016/j.jacep.2017.06.022
2. Zanon, F., Marcantoni, L., Baracca, E., Pastore, G., Lanza, D., Aggio, A., … Prinzen, F. (2016). Optimization of left ventricular pacing site plus multipoint pacing improves remodeling and clinical response of cardiac resynchronization therapy at 1 year. Heart Rhythm, 13(8),1644-1651. http://dx.doi.org/10.1016/j.hrthm.2016.05.015
3. Forleo, G. B., Santini, L., Giammaria, M., Potenza, D., Curnis, A., Calabrese, V., … Zanon, F. (2016). Multipoint Pacing via a quadripolar left-ventricular lead: Preliminary results from the Italian registry on multipoint left-ventricular pacing in cardiac resynchronization therapy (IRON-MPP). Europace, (17 May 2016), 1-8. http://dx.doi.org/10.1093/europace/euw094

QUADRA ASSURA MP™

Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Contents: Cardiac pulse generator

ORDERING INFORMATION 

Reorder Number

CD3369-40Q

Dimensions (H x W x T, mm)

76 x 41 x 14

Weight (g)

80

Volume (cc)

38

Connector

DF4, IS4, IS-1

SEE FULL PRODUCT DETAILS and any references for this product.

 

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IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Quadra Assura™

Cardiac Resynchronization Therapy Defibrillator (CRT-D)

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Brief Summary:

Prior to using these devices, please review the Instructions for Use for a complete listing indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications:

The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are also intended to resynchronize the right and left ventricles in patients with congestive heart failure.

Contraindications:

Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance or acute myocardial infarction.

Adverse Events:

Implantation of the pulse generator system, like that of any other device, involves risks, some possibly life-threatening. These include but are not limited to the following: acute hemorrhage/bleeding, air emboli, arrhythmia acceleration, cardiac or venous perforation, cardiogenic shock, cyst formation, erosion, exacerbation of heart failure, extrusion, fibrotic tissue growth, fluid accumulation, hematoma formation, histotoxic reactions, infection, keloid formation, myocardial irritability, nerve damage, pneumothorax, thromboemboli, venous occlusion. Other possible adverse effects include mortality due to: component failure, device-programmer communication failure, lead abrasion, lead dislodgment or poor lead placement, lead fracture, inability to defibrillate, inhibited therapy for a ventricular tachycardia, interruption of function due to electrical or magnetic interference, shunting of energy from defibrillation paddles, system failure due to ionising radiation. Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by: multiple counting of cardiac events including T waves, P waves or supplemental pacemaker stimuli. Among the psychological effects of device implantation are imagined pulsing, dependency, fear of inappropriate pulsing and fear of losing pulse capability.

Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

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