A Medical Device Daily

ELA Medical (Denver), a division of the Sorin Group (Milan, Italy), reported the first U.S. enrollment in the Optimal Anti-tachycardia Therapy in ICD Patients without Pacing Indications(OPTION) study by Dan Dan, MD, electrophysiologist and co-director of cardiovascular research of the Fuqua Heart Center at Piedmont Hospital (Atlanta).

The study evaluates ICDs with dual-chamber pacing and arrhythmia detection, with therapy enabled for slow ventricular tachyarrhythmias, compared to ICDs with single-chamber pacing and tachyarrhythmia detection, with therapy disabled for slow ventricular tachyarrhythmias.

Sorin's Ovatio DR 6550 ICD features specific arrhythmia detection algorithms — PARAD & PARAD+ (P and R based arrhythmia detection). It also has Sorin's pacing algorithm to minimize ventricular pacing, AAIsafeR. Additionally, it has a slow ventricular tachycardia zone, BTO (brady-tachy overlap) that is designed to "unlock pacing and detection" allowing bradycardia pacing in the slow-VT zone.

Dick Ames, senior VP of Sorin's U.S. cardiac rhythm management, said: "This is the first prospective study to address the surprising outcome of the DAVID trial by testing dual chamber pacing with a minimal ventricular pacing algorithm, AAIsafeR, in the ICD population. The OPTION Study is another example of Sorin Group's commitment to innovative technologies to provide clinical benefits and optimal therapies to patients."

Sorin makes medical technologies for cardiac surgery.

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