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Quadra Assura™ CRT-D

Elevating the Standard of Care

The Quadra Assura™ CRT-D and Quartet® LV pacing lead is the first-to-market quadripolar that enables LV pacing at the preferred site without compromising lead stability for better management of heart failure patients. These products feature new algorithms to elevate the standard of care in patient safety and therapy assurance.

Quadra Assura CRT-D
Overview

Revolutionizing CRT Pacing Options

Quadripolar technology offers:
  • More basal pacing opportunities without compromising lead stability. Studies have shown pacing more basally to be associated with reverse LV remodeling and improved outcomes1,2
  • More options to manage common pacing complications, such as phrenic nerve stimulation and high pacing thresholds, resulting in less need for lead repositioning and fewer surgical revisions3-6
VectSelect QuartetTM LV Pulse Configuration

VectSelect Quartet LV Pulse Configuration

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ShockGuard™ Technology

Expanded ShockGuard™ technology for protection against inappropriate and unnecessary shocks is available in the St. Jude Medical ICDs and CRT-Ds.

  • Approximately one-third of all ICD shocks are inappropriate7
  • Reducing shocks correlates with increased quality of life8
  • DecisionTx™ programming allows for better discrimination of arrhythmias resulting in the most appropriate therapy for the patient
  • Far Field MD morphology discrimination algorithm improves upon the use of near-field morphology analysis alone, further reducing inappropriate therapies
  • Chamber Onset discrimination algorithm utilizes both atrial and ventricular interval information for rhythm diagnosis to determine which chamber is driving the arrhythmia
  • SecureSense™ RV Lead Noise discrimination algorithm differentiates lead noise from true VT/VF episodes and provides the ability to automatically withhold tachycardia therapy in the presence of lead noise

Patient Safety Enhancements

DynamicTx™ Over-Current Detection Algorithm:
  • Checks for compromised vector integrity
  • Will attempt to find a viable configuration to deliver high voltage therapy, while avoiding a problematic vector

This feature will be beneficial because it provides the opportunity for devices to deliver a shock and possibly terminate a VT/VF episode even in the presence of a compromised lead.

Parylene Coatinga

Parylene serves as a protective barrier to reduce friction against the surface of CRT-D cans.

  • Lead-to-can is the most common failure mode across the industry
  • Bench testing data has demonstrated the addition of new coating reduces the risk of lead-to-can abrasion by at least 6X9,10

a Parylene coating only available on DF1

References

1 Singh JP et al. Left ventricular lead position and clinical outcome in the Multicenter Automatic Defibrillator Implantation Trial Cardiac Resynchronization Therapy (MADIT-CRT) Trial. Circulation. 2011 Mar 22;123(11):1159-66.
2 Merchant FM et al. Impact of segmental left ventricle lead position on cardiac resynchronization therapy outcomes. Heart Rhythm. 2010 May;7(5):639-44.
3 Forleo GB et al. Left ventricular pacing with a new quadripolar transvenous lead for CRT: early results of a prospective comparison with conventional implant outcomes.
  Heart Rhythm. 2011 Jan;8(1):31-7.
4 Data compiled from clinical study results, on file at St. Jude Medical in Report 60034670.
5 Moss AJ et al. Cardiac resynchronization therapy for the prevention of heart failure events. N Engl J Med. 2009;361:1329-38.
6 Gras D et al. Implantation of cardiac resynchronization therapy systems in the CARE-HF trial: procedural success rate and safety. Europace. 2007 Jul;9(7):516-22.
7 Daubert J, et al. Inappropriate Implantable Cardioverter-Defibrillator Shocks in MADIT II: Frequency, Mechanisms, Predictors, and Survival Impact. JACC. 2008;51(14):1357-1365.
8 Sears et al. Quality of Life and Psychological Functioning of ICD Patients. Heart 2002: 87: 488-493.
9 St. Jude Medical bench testing data doc no. 60045162
10 St. Jude Medical bench testing data doc no. 60045369

Tech Specs

Quadra Assura

Cardiac Resynchronization Therapy Defibrillator (CRT-D)
Ordering Information   View Catalog   

Contents: Cardiac pulse generator

Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
CD3265-40 83 x 41 x 14 83 40 DF1, IS4, IS-1
CD3265-40Q 76 x 41 x 14 81 38 DF4, IS4, IS-1

Indications, Safety & Warnings
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Quadra Assura

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN.

Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications: St. Jude Medical® ICDs and CRT-Ds are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

AF Suppressionpacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction.

In patients indicated for an ICD, CRT-Ds are also intended:

  • to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section included in the Merlin® PCS on-screen help) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration
  • to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III 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 ionizing 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.

Last Updated: December 23, 2014