This article was originally published in The Gray Sheet
Endovascular temperature management catheter's 510(k) clearance for use in surgery and critical care is the first of its kind, the firm maintains June 12. The device controls patient blood temperature during cardiac surgery and post-operative intensive care. An acute myocardial infarction indication is expected in the first half of 2003, based on a 400-patient, 25-center clinical study (1"The Gray Sheet" Feb. 25, 2002, p. 5)...
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