Recalled ICD Leads Can Be Extracted Safely, Cleveland Clinic Study Shows
This article was originally published in The Gray Sheet
A 10-year retrospective study from the Cleveland Clinic shows that implantable cardioverter defibrillator leads subject to recalls can be extracted with the same safety and efficacy as non-recalled ICD leads. Another study, published in the same issue of Heart Rhythm, found that younger age and female sex are independent predictors of failure for St. Jude’s Riata lead.
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St. Jude paid $123.5 million and agreed to up to $65 million in additional milestone payments to acquire Nanostim and its first-in-class leadless pacemaker, which has just earned a CE mark and is expected to launch in select European markets soon.
The firm reported during its second-quarter earnings call that its cardiac rhythm management business has stabilized after several quarters of market share decline.
The company hopes an independent analysis of its Optim-insulated Durata leads will address questions from the clinical community based on concerns with its earlier-generation Riata devices.