Guidant Omnilink .018
This article was originally published in The Gray Sheet
Executive Summary
Biliary stent system gains FDA market go-ahead for treatment of malignant biliary obstructions. Cleared less than a month after agency sign-off on the firm's Rx Herculink Plus biliary stent system for the same indication, the Omnilink system is an enhanced version of Guidant's Megalink SDS biliary stent system and features added strength, lower profile and thinner (Xcelon) expansion balloon material (1"The Gray Sheet" April 23, 2001, In Brief)
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Guidant
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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