The Kora Pacemaker is Safe and Effective for Magnetic Resonance Imaging.
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ABSTRACT: BACKGROUND:The impact of magnetic resonance imaging (MRI) on pacemakers is potentially hazardous. We present clinical results from a novel MRI conditional pacing system with the capability to switch automatically to asynchronous mode in the presence of a strong magnetic field. AIMS:The IKONE (Assessment of the MRI solution: KORA 100™ and Beflex™ pacing leads system) study is an open-label, prospective, multicenter study aimed at confirming the safety and effectiveness of the system, when used in patients undergoing MRI of anatomical regions excluding the chest. METHODS:Primary eligibility criteria included patients implanted with the system, with or without a clinically indicated MRI. The primary endpoint was to confirm no significant change in pacing capture thresholds at 1 month after an
SUBMITTER: Savoure A
PROVIDER: S-EPMC4536771 | biostudies-literature | 2015
REPOSITORIES: biostudies-literature
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