CARDIOVASCULAR
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EllipseVR

Single-Chamber Implantable Cardioverter Defibrillator (ICD)

Ellipse<sup>™</sup> VR

PRODUCT HIGHLIGHTS

  • New shape with reduced volume and thickness
  • TailoredTherapy features are designed to customize treatment to each patient’s unique needs, including: SecureSense RV lead noise discrimination, ShockGuard® technology, SenseAbility® sensing algorithm and DeFT Response® technology
  • ShockGuard technology with DecisionTx® programming is designed to reduce inappropriate therapy and minimize the need for programming adjustments at implant
  • SecureSense RV lead noise discrimination detects sustained and short bursts of lead noise for the reduction of inappropriate shocks
  • 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
  • RV AutoCapture pacing system monitors and regulates right-ventricular pacing with beat-by-beat support
  • The Low Frequency Attenuation filter is designed to enhance sensing performance and may reduce the possibility of oversensing T waves
  • The SenseAbility sensing algorithm allows flexibility to fine-tune programming around T-wave oversensing without decreasing sensitivity
  • Streamlined DF4 connector simplifies implants and reduces pocket bulk
  • 36 J delivered energy safety shock option can provide a greater defibrillation threshold (DFT) safety margin
  • DeFT Response technology offers the most noninvasive options for managing high DFTs
  • QHR®* battery chemistry provides greater capacity for enhanced longevity and improved charge time performance compared to previous SVO batteries
  • Unique vibratory notifier alerts patients to a low battery, lead-related complications and more

ORDERING INFORMATION

Contents: Cardiac pulse generator


Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector Defibrillation Connector Sense/Pace
CD1311-36 68 x 51 x 12 66 31 DF1 IS-1
CD1311-36Q 66 x 51 x 12 67 30 DF4 DF4
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*QHR is a registered trademark of Greatbatch Medical.


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

Contraindications: Contraindications for pulse generator system use 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.

Item No. F00128

Last Updated: January 02, 2019

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