Alsius, Radiant, InnerCool Heat Up Hypothermia Market Competition
This article was originally published in The Gray Sheet
Executive Summary
Alsius Corp. expects to be the first to market with an intravascular temperature management system for controlling fever in the neuro-critical care setting, pending FDA clearance of a December 2001 510(k) submission
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Radiant SetPoint
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)...
Radiant SetPoint
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)...
AHA In Brief
Boston Scientific TAXUS I: Angiographic analysis at six-month follow-up of 61 patients demonstrated zero edge effect at the proximal and distal edges in both the treatment and control arm of the paclitaxel-coated Nirx stent trial. Intravascular ultrasound (IVUS) analysis showed "significant improvements" in neointimal volume, percent neointimal volume index and minimum lumen area in the treatment group, the firm says. The newly reported data "expand on the impressive results reported earlier, and they reduce the concern that an edge effect may be the price we pay for reducing in-stent restenosis," commented Eberhard Grube, MD, Seigburg Heart Center, Siegburg, Germany...