Cameron defibrillator gains CE mark approval
This article was originally published in The Gray Sheet
Executive Summary
Cameron Health gains a CE mark for its S-ICD subcutaneous implantable cardioverter defibrillator. The device is indicated for patients at risk of sudden cardiac arrest. Unlike conventional ICDs, which require placement of at least one lead in or on the heart, the Cameron system implants leads just under the skin. Cameron is in the process of working out details with FDA on a U.S. clinical trial, which is expected to begin in the fourth quarter and support an eventual PMA submission (1"The Gray Sheet" June 8, 2009)
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