Guidant to apply for new ICD (implantable cardioverter defibrillator) indication
This article was originally published in Clinica
Executive Summary
Guidant plans to apply to the US FDA to expand the use of its implantable cardioverter defibrillators (ICDs) to include their use in patients at risk from sudden unexplained death syndrome (SUDS). The company's decision is based on results from the DEBUT (Defibrillator vs Beta-blockers for Unexplained Death in Thailand) study, which showed that ICDs were better than drugs in saving lives of people with SUDS who have no structural heart disease and a normal ejection fraction.