PRODUCT CATALOG

Cardiac Rhythm Management | Cardiac Resynchronization Therapy (CRT) Devices | CRT Defibrillator

Quadra Assura MP™

Cardiac Resynchronisation Therapy Defibrillator (CRT-D)

Description

Cardiac Resynchronisation Therapy Defibrillator (CRT-D)

Product Highlights

  • MRI Ready device tested in combination with MR Conditional leads for full-body scans using a 1.5 T (Tesla) field strength MRI Scanner*
  • MultiPoint™ pacing delivers multiple LV pacing pulses per cardiac cycle
  • SyncAV™ CRT offers dynamic AV timing with customizable programming to ensure BiV pacing with or without MultiPoint™ pacing
  • The Quadra Assura MP CRT-D and Quartet™ quadripolar LV pacing lead feature four pacing electrodes and 10 pacing vectors to provide more options and greater control to address implant complications such as diaphragmatic stimulation and high pacing thresholds
  • Easily test and program with Auto VectSelect Quartet™ Test offering an efficient workflow for complete results and programming at the touch of a button
  • DeFT Response™ technology offers noninvasive options for managing high DFTs with or without induction testing
  • DynamicTx™ Over-current Detection Algorithm automatically changes shock configurations to ensure delivery of high voltage therapy when high current is detected
  • Cold Can programmability provides an additional RV-SVC Shock Configuration to decouple the can from the shocking vector parameters in cases of lead problems
  • ShockGuard™ technology with DecisionTx™ programming designed to reduce inappropriate therapy and minimise the need for programming adjustments at implant
    – SecureSense™ RV lead noise discrimination detects sustained and short bursts of lead noise that would otherwise go unnoticed or potentially lead to one or more inappropriate shocks
     - Far Field MD™ morphology discrimination and Chamber Onset discrimination improve SVT and VT discrimination for reduced inappropriate therapies
  • Antitachycardia pacing (ATP) while charging and prior to charging in the VF zone further extends the programming options for terminating tachyarrhythmias without a highvoltage shock
  • SenseAbility™ sensing algorithm feature provides the flexibility to fine-tune programming around T-wave oversensing without decreasing sensitivity
  • DF4 connector designed to streamline defibrillation connections into a single terminal pin and reduce the number of set screws
  • Unique 40 J delivered energy safety shock option can provide a greater DFT safety margin
  • Vibratory patient notifier enables patients with hearing problems to be alerted to a low battery, lead-related complications and more
  • The CorVue™ Thoracic Impedance Monitoring feature utilizes multiple vectors to measure transthoracic impedance changes over time to provide additional insight into the patient’s heart failure condition
  • QuickOpt™ timing cycle optimisation provides quick and effective optimisation at the push of a button
  • QHR chemistry battery provides greater capacity for enhanced longevity and improved charge time performance compared to previous SVO batteries
Quadra Assura MP


Ordering Information

Cardiac pulse generator

Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector Note
CD3369-40Q 75 x 41 x 14 80 38 DF-4, IS4, IS-1 *See MRI scan restrictions

*See MRI scan restrictions

Rx Only


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: Abbott ICDs and CRT-Ds are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF Suppression™ pacing 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, deviceprogrammer 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.

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies.

©2018 St. Jude Medical, Inc. All rights reserved.

SJM-QD-0216-0046(2)

Customer Support: 855-478-5833

Last Updated: December 19, 2017