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Fortify™ ICD

This device is commercially available for use in select international markets.

Highest Delivered Energy for Greater Therapy Assurance

The Fortify ICD offers the highest available stored and delivered energy, algorithms to reduce unnecessary therapy, and total capture confirmation for enhanced safety and convenience. Featuring a 6 cc volume reduction from our previous generation of devices and uncompromised longevity, the Fortify ICD improves the implant and follow-up experience for physicians and their patients.
Fortify ICD
Overview

Downsize Without Compromise

Fortify ICD has the smallest footprint and the highest delivered energy of any ICD available. The device and its extensive feature set were designed for safety and reliability with extended longevities of 8.9 years* (DR) and 10.1 years* (VR).

Stronger

40 J of delivered energy for greater assurance of successful defibrillation

Smarter

ShockGaurdTM technology with DecisionTxTM programming, designed to reduce unnecessary or inappropriate shocks resulting in 98.5% of patients projected to be free of inappropriate shocks at 1 year post implant1

ATP while charging in the VF zone can convert many fast VTs painlessly without risking delay to shock therapy for rhythms that require it

Smaller

New downsized shape allows for a smaller incision and a smaller device pocket

 

Highest Available Energy

Only St. Jude Medical has the highest stored and delivered energy (45 J stored; 40 J delivered) to provide greater assurance of successful defibrillation.

Fortify ICD Stored Delivered Energy Chart


References

1 St. Jude Medical Merlin™ Patient Care System (PCS) Bradycardia and Tachycardia Devices Help Manual.
* 2.5V, 0.5ms, 500ohms, 60ppm, 25% pacing, 3 shocks/yr, implanted after 12 month shelf-life

MATERIALS & LINKS

Tech Specs

Fortify™ DR

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
CD2233-40 74 x 40 x 14 76 35 DF1 IS-1
CD2233-40Q 71 x 40 x 14 75 35 DF4 IS-1; DF4

Fortify™ VR

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
CD1233-40 73 x 40 x 14 76 35 DF1 IS-1
CD1233-40Q 71 x 40 x 14 75 35 DF4 DF4

Indications, Safety & Warnings
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Fortify™ DR

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.

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.

Fortify™ VR

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.

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.

Last Updated: 22 April 2013