CARDIOVASCULAR
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Promote® Plus

Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Promote® Plus

PRODUCT HIGHLIGHTS

  • The DF4 connector is designed to simplify implants by streamlining defibrillation connections into a single terminal pin and reducing the number of set screws.
  • Triple Redundancy Safety Platform is designed to minimize risk and increase security and patient comfort through multiple hardware and software system safeguards.
  • Vibratory Patient Notifier enables patients with hearing problems to be alerted to a low battery, lead-related complications and more.
  • TailoredTherapy™ features designed to customize treatment to each patient’s unique needs, including QuickOpt® Timing Cycle Optimization, which provides quick and effective optimization for more patients at the push of a button, VectSelect ® programmable LV pulse configuration and DeFT Response® Technology that allows more noninvasive programming flexibility in the management of DFTs.
  • AT/AF Alerts 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.

ORDERING INFORMATION

Contents: Cardiac pulse generator


Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector Defibrillation Connector Sense/Pace
CD3211-36Q 75 x 50 x 14 82 42 DF4 IS-1; DF4


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: The Promote® pulse generators are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF Suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. In patients indicated for an ICD, the Promote pulse generators are also intended to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section included in the Merlin Patient Care System [PCS] on-screen help) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration; to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure.

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.

Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the system, include, but are not limited to the following: acceleration of arrhythmias (caused by device), air embolism, allergic reaction, bleeding, cardiac tamponade, chronic nerve damage, death, erosion, exacerbation of heart failure, excessive fibrotic tissue growth, extracardiac stimulation (phrenic nerve, diaphragm, chest wall), extrusion, fluid accumulation, formation of hematomas or cysts, inappropriate shocks, infection, keloid formation, lead abrasion and discontinuity, lead migration/dislodgment, myocardial damage, pneumothorax, shunting current or insulating myocardium during defibrillation with internal, or external paddles, potential mortality due to inability to defibrillate or pace, thromboemboli, venous occlusion, venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD or CRT-D system that may include the following: dependency, depression, fear of premature battery depletion, fear of shocking while conscious, fear of losing shock capability, imagined shocking (phantom shock).

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

Rev.6-012511

Last Updated: January 02, 2019

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