Cardiac Rhythm Management | Implantable Cardioverter Defibrillator (ICD) Devices | Single-Chamber (ICD Devices)

Fortify Assura™ VR, Parylene Coating

Single-Chamber Implantable Cardioverter Defibrillator (ICD)

Product Highlights

  • Parylene coating for improved abrasion resistance
  • 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
  • ShockGuard™ technology with DecisionTx™ programming designed to reduce
    inappropriate therapy and minimize the need for programming adjustments at implant
    • SecureSense™ RV lead noise discrimination detects sustained and records short bursts
      of lead noise that would otherwise go unnoticed or potentially lead to one or more inappropriate shocks
    • Far Field MD™ morphology discrimination is designed to improve SVT and VT discrimination
      for reduced inappropriate therapies
  • SenseAbility™ feature provides flexibility to fine-tune programming around T-wave oversensing without decreasing sensitivity
  • 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
  • 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
  • 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
Next Generation Fortify Assura™ VR Single-Chamber ICD, Parylene Coating

Merlin at Home Transmitter Compatible

Ordering Information

Contents: Cardiac pulse generator

Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector Defibrillation Connector Sense/Pace
CD1357-40C 73 x 40 x 14 76 35 DF1 IS-1

*QHR is a trademark of Greatbatch Medical

Rx Only

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: The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

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.

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.

Item G-00525 (11/2013)

Customer Support: 855-478-5833

Last Updated: March 30, 2014