Frontier™ II Cardiac Resynchronisation Therapy Pacemaker
CARDIOVASCULAR
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Frontier™ II

Cardiac Resynchronisation Therapy Pacemaker

PRODUCT HIGHLIGHTS

  • QuickOpt™ Timing Cycle Optimisation provides quick and effective AF optimization at the touch of a button
  • Continuous Biventricular Pacing

– AF Suppression™ algorithm helps control atrial rhythm and maintains AV synchrony

– Negative AV/PV Hysteresis is designed to ensure biventricular pacing by temporarily shortening the AV/PV delay upon sensing ventricular activity

– DDT Biventricular Trigger Mode provides triggered pacing in the presence of intrinsic R-waves or PVCs to help promote biventricular pacing

– Mode Switch Base Rate helps manage ventricular activity during AF episodes

  • Exclusive AF Suppression™ Algorithm is clinically proven to reduce AF burden1 and improve quality of life2,3
  • AT/AF Burden Trend provides weekly count of the percent of time in AF and identifies long-term trends for device or drug management

ORDERING INFORMATION

Contents: Cardiac pulse generator


Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
5596 49 x 52 x 6 25 11.5(±0.5) IS-1

1. Carlson M et al. A new pacemaker algorithm for the treatment of atrial fibrillation, results of the Atrial Dynamic Overdrive Pacing Trial (ADOPT). JACC 2003; 42:627-33.

2. Attuel P et al and the INOVA Study Group. Quality of life in permanently paced AF patients. The INOVA Study. Europace 2003; Abstract A42-6.

3. Davy et al and the INOVA Study Group. Permanent atrial overdrive tolerance in patients with symptomatic paroxysmal AF. The INOVA Study Europace 2003; Abstract A42-3.


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: Implantation of Frontier II device is indicated for: maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure, the reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration, implantation of Accent™, Accent RF, Anthem, and Anthem RF devices is indicated in one or more of the following permanent conditions: syncope, presyncope, fatigue, disorientation, or any combination of those symptoms. Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber Pacing is indicated for those patients exhibiting: sick sinus syndrome, chronic, symptomatic second- and third-degree AV block, recurrent Adams-Stokes syndrome, symptomatic bilateral bundle branch block when tachyarrhythmia and other causeshave been ruled out. Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for patients with significant bradycardia and normal sinus rhythm with only rare episodes of A-V block or sinus arrest, chronic atrial fibrillation, severe physical disability. AF Suppression is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.

Contraindications: Implanted Cardioverter-Defibrillator (ICD). Devices are contraindicated in patients with an implanted cardioverter-defibrillator. Rate-Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates. An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient. AF Suppression stimulation is not recommended in patients who cannot tolerate high atrial-rate stimulation. Dual-Chamber Pacing, though not contraindicated for patients with chronic atrial flutter, chronic atrial fibrillation, or silent atria, may provide no benefit beyond that of single-chamber pacing in such patients. Single-Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing. Single-Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction. Atrial Fibrillation. Anthem devices are contraindicated in patients having chronic atrial fibrillation or intermittent atrial fibrillation that does not terminate. For specific contraindications associated with individual modes, refer to the programmer’s on-screen help.

Potential Adverse Events: The following are potential complications associated with the use of any pacing system: air embolism, body rejection phenomena, cardiac tamponade or perforation, hematoma, bleeding hematoma, seroma, formation of fibrotic tissue, local tissue reaction, inability to interrogate or program due to programmer or device malfunction, infection/erosion, interruption of desired pulse generator function due to electrical interference, either electromyogenic or electromagnetic, lead malfunction due to conductor fracture or insulation degradation, loss of capture or sensing due to lead dislodgement or reaction at the electrode/tissue interface, loss of desired pacing and/or sensing due to lead displacement, body reaction at electrode interface, or lead malfunction (fracture or damage to insulation), loss of normal device function due to battery failure or component malfunction, pacemaker migration or pocket erosion, pectoral muscle or diaphragmatic stimulation, phrenic nerve stimulation, pneumothorax/hemothorax, endocarditis, excessive bleeding, induced atrial or ventricular arrhythmias, myocardial irritability, pericardial effusion, pericardial rub, pulmonary edema, rise in threshold and exit block, valve damage, cardiac/coronary sinus dissection, cardiac/coronary sinus perforation, coronary sinus or cardiac vein thrombosis.

Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

Item GMCRM910EN

Last Updated: January 02, 2019

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