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Ellipse™ ICD

A New Angle On Technology

The Ellipse ICD is the industry’s smallest high-energy device and features a superb balance between footprint (surface area occupied by the device) and thinness. The device incorporates a small 30 cc size (VR DF4 model); thin 12 mm profile; unique angled header; 36 J delivered energy.

Ellipse ICD
Overview

A New Angle on Technology

The Ellipse ICD is the industry’s smallest high-energy device and features a superb balance between footprint* and thinness.

  • Small 30 cc size**
  • Thin 12 mm profile
  • Unique angled header designed to improve lead wrap
  • 36 J delivered energy

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.

SecureSense™ RV Lead Noise Discrimination algorithm expands ShockGuard technology and differentiates lead noise from true VT/VF episodes.1

  • 100% detection of clinical VF (detected 853 out of 853 true VF episodes)2
  • 97.1% detection of sustained RV lead noise (detected 231 out of 238 sustained lead noise EGM episodes)2
  • 90.4% detection of non-sustained RV lead noise (detected 47 out of 52 non-sustained lead noise EGM episodes)2

Enhanced ShockGuard Chart

TailoredTherapy™ Features

DeFT ResponseTM Technology - Exclusive, customizable programming to tailor the therapy to meet the unique needs of each patient

Complete Capture Confirmation - Automatic pacing outputs, periodically measured and adjusted, for optimal therapy delivery in every chamber of the heart

Other Key Features

  • Streamlined DF4 connector, which simplifies implants and reduces pocket bulk
  • QHRTM† battery chemistry, which provides greater capacity for enhanced longevity and improved charge time performance compared to previous SVO batteries

References

*Defined as the surface area occupied by the device

**VR DF4 model

†QHR is a registered trademark of Greatbatch Medical.

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

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

Tech Specs

EllipseDR

Dual-Chamber Implantable Cardioverter Defibrillator (ICD)
Ordering Information   View Catalog   

Contents: Cardiac pulse generator

Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector Defibrillation Connector Sense/Pace
CD2311-36 69 x 51 x 12 66 31 DF1 IS-1
CD2311-36Q 70 x 51 x 12 68 31 DF4 IS-1; DF-4

EllipseVR

Single-Chamber Implantable Cardioverter Defibrillator (ICD)
Ordering Information   View Catalog   

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

Indications, Safety & Warnings
Print

EllipseDR

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN.

Rx Only

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.

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.

EllipseVR

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.

Last Updated: April 19, 2013