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Ellipse™ ICD

Elevating the Standard of Care

Designed by physicians for better patient comfort and physiologic fit. Features new algorithms to elevate the standard of care in patient safety and therapy assurance.

  • Automatic vector switching algorithm
  • Algorithms for protection against inappropriate and unnecessary shocks
  • Small 30 cc sizeb
  • Thin 12 mm profile
  • Unique angled header designed to improve lead wrap
  • 36 J delivered energy
a Defined as the surface area occupied by the device
b VR DF4 model
Ellipse DR ICD
Overview

ShockGuard™ Technology

Expanded ShockGuard™ technology for protection against inappropriate and unnecessary shocks is available in the St. Jude Medical ICDs and CRT-Ds.

  • Approximately one-third of all ICD shocks are inappropriate1
  • Reducing shocks correlates with increased quality of life2
  • DecisionTx™ programming allows for better discrimination of arrhythmias resulting in the most appropriate therapy for the patient
  • Far Field MD morphology discrimination algorithm improves upon the use of near-field morphology analysis alone, further reducing inappropriate therapies
  • Chamber Onset discrimination algorithm utilizes both atrial and ventricular interval information for rhythm diagnosis to determine which chamber is driving the arrhythmia
  • SecureSense™ RV Lead Noise discrimination algorithm differentiates lead noise from true VT/VF episodes and provides the ability to automatically withhold tachycardia therapy in the presence of lead noise

Patient Safety Enhancements

DynamicTx™ Over-Current Detection Algorithm:
  • Checks for compromised vector integrity
  • Will attempt to find a viable configuration to deliver high voltage therapy, while avoiding a problematic vector

This feature will be beneficial because it provides the opportunity for devices to deliver a shock and possibly terminate a VT/VF episode even in the presence of a compromised lead.

Parylene Coatingc

Parylene serves as a protective barrier to reduce friction against the surface of ICD cans.

  • Lead-to-can is the most common failure mode across the industry
  • Bench testing data has demonstrated the addition of new coating reduces the risk of lead-to-can abrasion by at least 6X3,4

c Parylene coating only available on DF1

References

1 Daubert J, et al. Inappropriate Implantable Cardioverter-Defibrillator Shocks in MADIT II: Frequency, Mechanisms, Predictors, and Survival Impact. JACC. 2008;51(14):1357-1365.
2 Sears et al. Quality of Life and Psychological Functioning of ICD Patients. Heart 2002: 87: 488-493.
3 St. Jude Medical bench testing data doc no. 60045162
4 St. Jude Medical bench testing data doc no. 60045369

Tech Specs

Ellipse™ VR, No Coat

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
CD1411-36Q 66 x 51 x 12 67 30 DF4 DF4

Ellipse™ VR, Parylene Coating

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
CD1411-36C 68 x 51 x 12 66 31 DF1 IS-1

EllipseDR

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

Contents: Cardiac pulse generator


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

Ellipse™ VR, No Coat

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.

Ellipse™ VR, Parylene Coating

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.

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: December 23, 2014