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This article was originally published in The Gray Sheet

Executive Summary

Rx Herculink Plus biliary stent system gains FDA market go-ahead for treatment of malignant biliary obstructions. Based on the previous generation Rx Herculink, the next-generation system incorporates an enhanced stent design to increase lesion coverage, Xcelon expansion balloon material for improved deliverability, and single-operator 0.014" guidewire. Separately, Guidant says it plans to pursue approval of an implantable defibrillator indication for those at risk of hereditary sudden unexplained death syndrome (SUDS), following a randomized, 61-patient Thai study. Data show that ICDs appear better than drugs in saving the lives of potential SUDS patients who have no structural heart disease and a normal ejection fraction. Of the 11 SUDS events, four beta-blocker patients died and seven ICD patients survived

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