Brief Statement
Indications:
CRT-D
The Consulta and Maximo II CRT-D systems are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias and 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 and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration. In addition, the Consulta CRT-D system is indicated for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias. The Consulta CRT-D system’s atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in ICD-indicated patients with atrial septal lead placement and an ICD indication.
ICD
The Secura DR and VR systems, and the Maximo II DR and VR systems, are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. Due to the addition of the OptiVol diagnostic feature, the Secura devices indications are limited to the NYHA functional class II/III heart failure patients who are indicated for an ICD. The clinical value of the OptiVol fluid monitoring diagnostic feature has not been assessed in those patients who do not have fluid retention related symptoms due to heart failure. In addition, the Secura DR system is indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias. The Secura DR system’s atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in ICD-indicated patients with atrial septal lead placement and an ICD indication. Additional Secura DR System Notes: The use of the Secura DR system has not been demonstrated to decrease the morbidity related to atrial tachyarrhythmias. The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 17%, and in terminating device classified atrial fibrillation (AF) was found to be 16.8%, in the VT/AT patient population studied. The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 11.7%, and in terminating device classified atrial fibrillation (AF) was found to 18.2% in the AF-only patient population studied.
Contraindications: The Consulta and Maximo II CRT-D systems, the Maximo II DR/VR systems, and the Secura DR/VR systems are contraindicated for patients experiencing tachyarrhythmias with transient or reversible causes including, but not limited to, the following: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, or sepsis. The devices are contraindicated for patients who have a unipolar pacemaker implanted. In addition, the devices are contraindicated for patients with incessant VT or VF.
System Specific Contraindications:
- The Consulta CRT-D device is also contraindicated for patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF.
- The Secura DR system is also contraindicated for patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF. The Secura VR system is contraindicated for patients whose primary disorder is atrial tachyarrhythmia.
- The Maximo II DR/VR devices are also contraindicated for patients whose primary disorder is atrial tachyarrhythmia.
Warnings and Precautions: For the Consulta and Maximo II CRT-D systems, the Maximo II DR/VR systems, and the Secura DR/VR systems, changes in a patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device.
System Specific Warnings:
- For Consulta and Maximo II CRT-D systems, certain programming and device operations may not provide cardiac resynchronization.
Potential Complications: Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate tachyarrhythmia episodes, acceleration of ventricular tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis.
See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
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