Unify Assura™ Cardiac Resynchronisation Therapy Defibrillator (CRT-D)
CARDIOVASCULAR
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Unify Assura™

Cardiac Resynchronisation Therapy Defibrillator (CRT-D)

Unify Assura™

PRODUCT HIGHLIGHTS

  • 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 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 high-voltage shock
  • The Low Frequency Attenuation filter is designed to enhance sensing performance and may reduce the possibility of oversensing T waves
  • The SenseAbility™ feature provides the flexibility to fine-tune programming around T-wave oversensing without decreasing sensitivity
  • The DF4 connector is designed to simplify implants by streamlining defibrillation connections into a single terminal pin and reducing the number of set screws
  • Unique 40 J delivered energy safety shock option can provide a greater DFT safety margin
  • DeFT Response™ technology offers the most noninvasive options for managing high DFTs
  • QHR™* chemistry battery provides greater capacity for enhanced longevity and improved charge time performance compared to previous SVO batteries
  • Vibratory patient notifier enables patients with hearing problems to be alerted to a low battery, lead-related complications and more
  • Smallest footprint of any HV device available
  • The CorVue™ congestion monitoring feature monitors the intrathoracic impedance in multiple vectors for improved accuracy, and it provides the option for both patient and physician alerts
  • Triggered pacing with BiVCap™ Confirm Trigger Mode helps maintain a high percentage of BiV pacing by triggering pacing in both the left and right ventricles in response to a sensed ventricular event
  • Negative AV hysteresis with search promotes ventricular pacing by automatically reducing the AV delay when intrinsic activity is present, thereby promoting a high degree of ventricular pacing
  • QuickOpt™ Timing Cycle Optimization provides quick and effective optimization at the push of a button

ORDERING INFORMATION

Contents: Cardiac pulse generator


Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector Defibrillation Connector Sense/Pace
CD3261-40 79 x 40 x 14 78 36 DF1 IS-1
CD3261-40Q 73 x 40 x 14 77 36 DF4 DF4; IS-1
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DRAFT SPECIFICATIONS; CE MARK PENDING

*QHR is a trademark of Greatbatch Medical

 


Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Devices depicted may not be available in all countries. Check with your St. Jude Medical representative for product availability in your country.

Indications: The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) are also intended to resynchronise 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 potentialadverse events.

 

Item GMCRM910EN

Last Updated: January 02, 2019

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