Cardiac Rhythm Management | Cardiac Resynchronization Therapy (CRT) Devices | CRT Pacemaker

Allure Quadra™ RF

Cardiac Resynchronization Therapy Pacemaker

Product Highlights

  • The Allure Quadra™ CRT-P and quadripolar LV pacing lead features four pacing electrodes and 14 pacing vectors to provide more options for CRT efficacy, reduced complications and implant success
  • Physician preferred physiologic shape with angled header designed for improved lead wrap
  • InvisiLink™ wireless telemetry system with the Merlin@home™ transmitters and™ Patient Care Network (PCN), allows for daily remote monitoring and streamlined follow-up
  • CorVue™ Thoracic Impedance Monitoring feature measures transthoracic impedance changes over time to provide additional insight in a patient’s heart failure status
  • The DirectTrend™ Report provides a summary of three month daily, one year weekly or one year daily diagnostic trends
  • Day one monitoring of heart failure patients when paired with the Merlin@home™ transmitter at point of care.
  • AT/AF Alerts can be programmed to notify patients and their clinics when a programmed AT/AF threshold or continuous episode duration has been exceeded, or when a high ventricular rate accompanies the AT/AF episode
  • Exclusive AF Suppression™ algorithm is clinically proven to suppress episodes of paroxysmal and persistent AF
  • AT/AF burden trend provides a graphical representation of the percentage of time in AT/AF and the number of AT/AF episodes in the previous 52 weeks
  • QuickOpt™ timing cycle optimization provides quick and effective optimization at the push of button
  • Up to 14 minutes of stored electrograms help identify key intrinsic and pacemaker-related events and simplify the diagnosis of complex ECG rhythms associated with heart failure
  • Industry-leading longevity offers 8 years of service life supported by a 6 year warranty*

Merlin at Home Transmitter Compatible

Ordering Information

Contents: Cardiac pulse generator

Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
PM3242 56 x 59 x 6 27 15 IS4-LLLL, IS-1

*Longevity calculated based on the following settings: 2.5 V, 500 Ohm, 60 BPM, 100% DDD-BiV Pacing, 0.4 ms, Cap Confirm Off, and Stored EGM On

Indications: Implantation of Allure and Allure RF devices 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 Assurity, Endurity and Allure family of 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 causes have 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 algorithm 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.

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies.

©2018 St. Jude Medical, Inc. All rights reserved.

US-2000335 A EN (2/14)

Customer Support: 855-478-5833

Last Updated: March 23, 2014