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Fortify™ ST ICD

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

Continuous ST Segment Monitoring for Unprecedented Insight

The Fortify ST ICD provides continuous ST segment information to potentially link VT/VF episodes and other clinical events to ST segment changes for improved insight in decision making. Featuring the industry’s highest available delivered energy, algorithms to reduce unnecessary therapy, and a 6 cc volume reduction from our previous generation of devices, Fortify ST ICD provides unprecedented insight, greater therapy assurance, and enhanced patient management.

 

This product is not approved by the United States FDA.

Fortify ST ICD
Overview

Downsize Without Compromise

Fortify ST 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

Continuous ST segment monitoring to potentially link VT/VF episodes with ischemia for improved insight in medical decision making

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

Smaller

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

 

Clinical Relevance of Diagnostic Data

The Fortify ST ICD provides a powerful combination of three important diagnostic reports. Combined with other diagnostic information, these three reports provide a level of critical detail not previously available.
A. ST Deviation Trending: Diagnostic shows the total span of the deviations over time
B. Histograms: ST deviations are plotted in a histogram to visually represent shifts in the ST segment
C. ST Episode Log: Only the most significant events are captured, allowing automated viewing of the SEGM

Fortify ST ICD Diagnostic Data

+ Enlarge Image


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
Tech Specs

Fortify™ ST 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
CD2235-40 74 x 40 x 14 76 35 DF1 IS-1
CD2235-40Q 71 x 40 x 14 75 35 DF4 IS-1; DF4

Indications, Safety & Warnings
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Fortify™ ST 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.

Last Updated: 19 April 2013