ELA Medical, a Sorin Group company, has launched the Ovatio implantable cardioverter defibrillators (ICDs). ELA Medical's new range of ICDs comprises a dual chamber model - Ovatio DR, and a single chamber model - Ovatio VR.
Ovatio devices are the world's smallest ICDs (29cc; 11mm thin). Physiologically-shaped and long-lasting, Ovatio ICDs also offer 34 joules of maximum output, which is useful for patients whose defibrillation threshold is particularly high and who may require more energy to terminate life-threatening arrhythmias.
The Ovatio ICD range includes features dedicated both to pacing and arrhythmia management as well as advanced diagnostic features that offer significant patient benefits. The dual chamber Ovatio DR includes two features: AAIsafeR and PARAD+ (P And R Arrhythmia Detection). AAIsafeR promotes natural heart activity by limiting unnecessary stimulation in the right ventricle, which prevents onset and progression of heart failure.
With AAIsafeR mode, Ovatio DR ICD continuously monitors the patient's intrinsic atrioventricular (AV) conduction and delivers ventricular pulses only when necessary. The patient's AV conduction can fully be documented through detailed statistics and intracardiac electrograms (IEGMs). AAIsafeR reduces the amount of ventricular pacing to less than 0.2% in ICD patients with intrinsic conduction. Conventional dual-chamber ICDs unnecessarily pace this patient population 50% of the time. AAIsafeR pacing technology has been available in Europe since September 2003.
Since it is important that ICD patients not only receive appropriate therapies but also receive them only when necessary, Ovatio DR includes PARAD+, a specific ventricular arrhythmia detection software package. PARAD+ is intended to protect patients from inappropriate shocks that may result from misclassified supraventricular tachyarrhythmias.
While supraventricular tachyarrhythmias have been reported to trigger between 55% and 69% (Prasad et al. Indian Heart Journal July-August 1997; and Korte et al. Pacing and Clinical Electrophysiology July 2004, respectively) of inappropriate shocks, PARAD+ demonstrated a 99% overall specificity with out-of-the-box settings in a study recently published (Hintringer et al. Pacing and Clinical Electrophysiology, 2004; 27: 976-982). Ovatio DR is therefore capable of accurately diagnosing supraventricular tachyarrhythmias 99% of the time, thus drastically reducing the number of inappropriate shocks.
Ovatio DR is also capable of detecting and treating the full spectrum of tachyarrhythmias through painless anti-tachycardia pacing. The company hopes that the device's ability to terminate the slowest (around 100 bpm) as well as the fastest (up to 255 bpm) ventricular tachyarrhythmias will offer ICD patients the comfort of painless therapy.
The first post-launch Ovatio implant was performed at the Medizinische Klinik und Poliklinik of Heidelberg, Germany, in the department of Internal Medicine by Dr Alexander Bauer. The patient implanted with the first Ovatio VR was an 82-year-old woman who suffered from ischaemic cardiomyopathy. Bauer declared: "The implant procedure went very smoothly. The shape and size of Ovatio VR made it easy to implant. Programming the ICD was also extremely simple with the user-friendly new Ovatio programming software." Bauer also commented on Ovatio DR saying that "minimal ventricular pacing technology is a must-have feature of today's ICDs. The uniqueness of AAIsafeR lies in its exclusive and fully documented monitoring of the AV conduction".
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