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Quadra Assura™ CRT-D

Revolutionizing CRT Pacing Options

The Quadra Assura CRT-D and QuartetLV pacing lead feature first-to-market quadripolar technology. With four electrodes and ten pacing configurations, this innovative second-generation CRT system enables LV pacing at the preferred site without compromising lead stability for better management of heart failure patients.

Quadra Assura™ CRT-D
Overview

Options Without Limits

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

+ Enlarge Image

 

Options for Shock Management

After one year, 98.5% of patients with ShockGuardTM technology and DecisionTxTM programming are projected to be free of inappropriate shocks—without compromising sensitivity.7

SecureSenseTM RV Lead Noise Discrimination algorithm expands ShockGuard technology and differentiates lead noise from true VT/VF episodes.

  • 100% detection of clinical VF (detected 853 out of 853 true VF episodes)8
  • 97.1% detection of sustained RV lead noise (detected 231 out of 238 sustained lead noise EGM episodes)8
  • 90.4% detection of non-sustained RV lead noise (detected 47 out of 52 non-sustained lead noise EGM episodes)8
Enhanced ShockGuard Chart

Other Key Features

TailoredTherapyTM features designed to customize treatment to each patient’s unique needs, including:

  • DeFT ResponseTM technology, which provides more noninvasive programming flexibility in the management of DFTs and 40 J delivered energy for a greater safety margins
  • Antitachycardia pacing (ATP) while charging and prior to charging in the VF zone, which further extends the programming options for converting tachyarrhythmias before or during charge
  • QuickOptTM timing cycle optimization, which provides quick and effective optimization for more patients at a push of a button
  • The % BiV-Pacing alert, which notifies clinics when biventricular pacing is less than the programmed threshold
  • Automatic pacing outputs, periodically measured and adjusted, for optimal therapy delivery in every chamber of the heart
  • Streamlined DF4 connector, which simplifies implants and reduces pocket bulk
  • Built on the proven UnifyTM CRT-D platform, downsized device for smaller footprint without compromising longevity, quality or reliability
  • QHR®* battery chemistry, which provides greater capacity for enhanced longevity and improved charge time performance compared to previous SVO batteries

References

*QHR is a registered trademark of Greatbatch Medical

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 St. Jude Medical Merlin® Patient Care System Bradycardia and Tachycardia Devices Help Manual.

8 Results based on stored electrogram clip testing. Data on file, St. Jude Medical Test Report, doc 60037865.

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: April 19, 2013