CardioExchange Archive

March 7th, 2012

Software Tool Could Provide Early Warning of ICD Lead Failure

Larry Husten, PHD

In recent years, defects in ICD leads have caused recalls and provoked broad concerns among healthcare professionals and patients alike about the safety and reliability of ICDs and other implanted cardiac devices. Now a key player in these events proposes that a computer software program can better monitor ICD leads and provide earlier warnings of […]

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February 16th, 2012

What Are the Lessons of the Riata ICD Lead Recall?

Edward J. Schloss, MD

Let’s enforce a robust, active postmarket surveillance system that will allow doctors in the field to draw their own conclusions about the safety of devices based on much better data without hampering innovation.

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September 12th, 2011

Global Monitor: Early Signs of Possible Problems with ICD Leads, Dabigatran

Larry Husten, PHD

Reports from Ireland and New Zealand may herald new concerns about Riata defibrillator leads (St. Jude Medical) and dabigatran (Pradaxa). A poster presented at the European Society of Cardiology meeting last month by researchers at the Royal Victoria Hospital in Belfast found that 15% of 212 patients who received Riata leads had an insulation breach on screening. The researchers reported that […]

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