FDAnews Device Daily Bulletin

EARLY DIAGNOSIS AND TREATMENT STRATEGY USING MEDTRONIC IMPLANTABLE HEART MONITOR REDUCES FAINTING

Sept. 7, 2005
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The use of an integrated diagnosis and treatment strategy for certain patients who experience episodes of suspected neurally mediated syncope (fainting) leads to a major reduction in the recurrence of syncope, according to a study presented today in a Hot Line session at the European Society of Cardiology (ESC) Congress 2005 in Stockholm, Sweden. Investigators in the International Study on Syncope of Uncertain Etiology 2 (ISSUE2) trial used a new risk stratification and treatment strategy to identify which patients with neurally mediated syncope can benefit most from an implantable device and experience a reduction in fainting episodes. The strategy includes a simple initial evaluation, early use of the Medtronic Reveal Plus insertable loop recorder (ILR), assessment of the exact mechanism of syncope and prescription of a mechanism-based therapy.

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