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Accent™ Pacemaker

Simplified Patient Management
From Implant Through Follow-up

The Accent family of low voltage devices delivers simplified patient management from implant through follow-up.

Accent RF pacemaker features daily wireless remote monitoring, providing timely notification of actionable events and flexible remote follow-up scheduling.

Accent pacemaker (inductive) is the industry's smallest dual chamber and single chamber device capable of remote follow-up through Merlin.net Patient Care Network (PCN).

Overview

Accent pacemakers are designed to enhance patient safety, improve clinic efficiencies and deliver tailored therapy.

Enhanced Safety and Reliability

Remote monitoring and follow-up are designed to provide earlier detection of clinical events.

  • Remote monitoring technology enables the transmission of patient data to clinicians — providing more timely notification of changes in device and patient disease status.
  • Programmable, audible alerts can notify patients to any arrhythmia or device changes.
  • Industry-leading longevity of 9 years* (dual chamber) is supported by a seven-year warranty1.

Improved Clinic Efficiencies

Remote monitoring provides key diagnostic information automatically.

  • Remote follow-up via the Merlin@homeTM transmitter supports clinic efficiencies by allowing scheduled follow-ups to happen from home, thus promoting patient compliance.
  • Interactive DirectCallTM Message voice response system eliminates the need for routine follow-up calls.
  • Comprehensive diagnostics, available through Merlin.net PCN, may replace the need for routine office visits.

Proven TailoredTherapyTM Features

Flexible programmability delivers optimal therapy based on patient needs.

  • SenseAbilityTM technology provides programming flexibility for accurate sensing over a wide range of atrial and ventricular signals by adjusting during every beat.
  • Ventricular Intrinsic Preference (VIPTM**) is proven2 to reduce unnecessary RV pacing—which has been shown to reduce the risk of heart failure3,4—while supporting the ventricle for every non-conducted beat, to promote AV synchrony.
  • Ventricular AutoCapture™ Pacing System addresses changing thresholds by automatically controlling pacing amplitude and monitoring ventricular capture with every pacing pulse.
  • AF Suppression™** technology is clinically proven to suppress episodes of paroxysmal and persistent AF5.

References

* With stored electrograms turned on

** Not available in the Accent SR RF single-chamber pacemaker.

1 From internal bench testing. Data on file at St. Jude Medical. Refers to in-clinic interrogation of the device via the Merlin Patient Care System programmer.

2 Hanna G et al. Reduction of ventricular pacing in pacemaker patients using Ventricular Intrinsic Preference: preliminary results from the VIP trial. Europace Supplement, July 2008.

3 Wilkoff BL, Cook JR, Epstein E, et al. DAVID Investigators. Dual-Chamber Pacing or Ventricular Backup Pacing in Patients With an Implantable Defibrillator. JAMA 2002. 288 (24): 3115-3123.

4 Olshansky B, Day JD, Moore S, et al. Is Dual-Chamber Programming Inferior to Single-Chamber Programming in an Implantable Cardioverter-Defibrillator? Results of the INTRINSIC RV (Inhibition of Unnecessary RV Pacing With AVSH in ICDs) Study. Circulation 2007. 115: 9-16.

5 Carlson M, Ip J, et al. A new pacemaker algorithm for the treatment of atrial fibrillation, results of the atrial dynamic overdrive pacing trial (ADOPT). Journal of the American College of Cardiology. 2003:42:626-633.


MATERIALS & LINKS

Tech Specs

Accent® SR RF

Single-Chamber Pacemaker
Ordering Information   View Catalog   

Contents: Cardiac pulse generator

Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
PM1210 52 x 52 x 6 23 12.8¹ IS-1

Accent® SR

Single-Chamber Pacemaker
Ordering Information   View Catalog   

Contents: Cardiac pulse generator

Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
PM1110 42 x 52 x 6 18 9.5¹ IS-1

Indications, Safety & Warnings
Print

Accent® SR RF

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: Implantation is indicated in one or more of the following permanent conditions: syncope, presyncope, fatigue, disorientation due to arrhythmia/bradycardia, 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. 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.

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. 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. 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, device migration and pocket erosion, endocarditis, excessive bleeding, induced atrial or ventricular arrhythmias, myocardial irritability, pericardial effusion, pericardial rub, pulmonary edema, rise in threshold and exit block, valve damage.

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

Accent® SR

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: Implantation is indicated in one or more of the following permanent conditions: syncope, presyncope, fatigue, disorientation due to arrhythmia/bradycardia, 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. 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.

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. 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. 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, device migration and pocket erosion, endocarditis, excessive bleeding, induced atrial or ventricular arrhythmias, myocardial irritability, pericardial effusion, pericardial rub, pulmonary edema, rise in threshold and exit block, valve damage.

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

Last Updated: September 19, 2014