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Product Guide: Implantable Cardioverter Defibrillators (ICDs)
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The following is our Cardiology Today Product Guide. Cardiology Today offered ICD manufacturers and marketers the opportunity to be listed here in our 2011 Guide. However, appearance does not imply endorsement by the chief medical editor or publisher of Cardiology Today. All of the information was supplied by the manufacturers; please contact them for more information. The editors regret any omissions.
Current Plus, Current Accel
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The Current Plus from St. Jude Medical was FDA approved in May 2009 and provides ventricular anti-tachycardia pacing and ventricular defibrillation. The single-chamber VR is 41 cc; the dual-chamber DR is 42 cc. Each has 36 J of delivered energy. Similarly the Fortify, the Current is designed to suppress AF. This device features a smooth header profile to improve terminal pin visibility and allow easier lead connection. The suite of diagnostic features in the Current Plus includes: an arrhythmia alert system for both patients and clinicians; atrioventricular extension of up to 450 ms, preventing unnecessary right ventricular pacing; all defibrillation connections running through a single terminal pin to help avoid lead-to-port mismatch; three tiers of hardware and software redundancies for ensured delivery of defibrillation and pacing therapy. The Current Accel ICD, approved by the FDA in January 2010, offers essentially the same features as the Current Plus, although with more sophisticated threshold adaptability in its pacing system.
Fortify
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St. Jude Medical’s Fortify system, approved for use by the FDA in May 2010, provides ventricular anti-tachycardia pacing and ventricular defibrillation. Both the DR and VR models are 35 cc. Study data showed that the device’s atrial fibrillation suppression feature lowered paroxysmal and persistent AF by 25%. The device’s 40 J of stored energy is intended for patients with high defibrillation threshold and is supported by a mixed-chemistry cell battery (the QHR by Greatbatch), which the manufacturer states has “extended longevities of 8.9 years (DR) and 10.1 years (VR).” The device’s diagnostic features include: a pacing system that sends a 5-V backup pulse when noncapture is detected; atrial amplitude adjustment according to changes sensed by the device; and a clinician alert system for when ventricular pacing is greater than the intended threshold.
Maximo II
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Medtronic’s Maximo II system, intended for medically refractive patients of ventricular arrhythmias, provides ventricular anti-tachycardia pacing and ventricular defibrillation. The device is also indicated for NYHA Class III and IV patients with medical refractory who have a left ventricular ejection fraction of 35% or less and prolonged QRS duration. The Maximo II DR and VR are both 37 cc; the DR’s battery life, according to the manufacturer, is about 8 years; the VR battery life is about 9 years. An integrated wireless platform offers: programmable alerts; auto-scan adjustments according to a patient’s real-time statistics; anti-tachycardia pacing, as well as managed ventricular pacing.
Secura
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The Medtronic Secura system, FDA-approved as of March 2008, is intended for patients with medical therapy refractory who experience ventricular arrhythmias with NYHA Class II/III HF. The Secura DR system is indicated for this same patient population who also experience atrial tachyarrhythmias or who are at risk for developing them. The Secura line includes a fluid status monitor with alerts that precede symptoms of fluid in the lungs. The Secura is 37 cc with 39 J of stored energy and an average battery life of 8 years. The device operates on the manufacturer’s integrated wireless platform, offering programmable alerts; auto-scan adjustments according to a patient’s real-time statistics; and anti-tachycardia pacing, as well as managed ventricular pacing, to eliminate unnecessary shocks.
Teligen
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The Teligen from Boston Scientific received FDA approval in May 2008 and has a pocket size of 31.5 cc. It is intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation in patients with ventricular arrhythmias. High defibrillation threshold patients are accommodated by 41 J of stored energy and programmable shock vectors. Right ventricular pacing options include algorithm for intrinsic conduction, extendable to 400 ms, with backup pacing for every beat, and options for fixed or dynamic atrioventricular delays. The Teligen operates on an integrated platform with wireless capabilities and real-time patient data.
Virtuoso
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The Medtronic Virtuoso DR/VR system was first approved by the FDA in May 2006. It is intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation in patients with NYHA Class II/III HF. With its fluid status monitor, the Virtuoso is also intended for NYHA Class II/III HF patients who are indicated for an ICD. This device also has atrial rhythm management features intended to suppress atrial tachyarrhythmias. The device is wireless and offers: programmable alerts; auto-scan adjustments according to a patient’s real-time statistics; anti-tachycardia pacing, as well as managed ventricular pacing.
– Compiled by Whitney McKnight; Photo credits: all photos courtesy of the manufacturers.