An author of a new report detailing five cases of conductor-extrusion-associated thrombi on Riata leads discusses his recommendations for screening and lead removal.
A case report of a failed St. Jude Medical Durata ICD lead was published yesterday, raising suspicions that this lead may share some of the same potential failure mechanisms of its troubled predecessor, the Riata lead. St. Jude’s ICD lead troubles date back to early case reports involving the Riata and Riata ST leads that ultimately…
This content is exclusive to CardioExchange. To continue reading, please log in or request an invitation.
The researcher and EP who first documented problems with St. Jude next generation leads reacts to the FDA’s recent letter to the company and explains what he is doing for patients who have received these devices.
The FDA on Tuesday released the full text of a warning letter sent last week to St. Jude Medical. The company had previously disclosed the existence of the letter in an SEC filing but did not make clear the full extent of the FDA warning. The letter from the FDA is the latest in a series of setbacks and challenges…
This content is exclusive to CardioExchange. To continue reading, please log in or request an invitation.
The Heart Rhythm Society meeting kicked off in Boston this morning. Edward Schloss recounts the important opening session in which FDA-recalled St. Jude ICD leads Riata, Riata ST, and Durata were discussed.
Rejecting an extraordinary request from industry to retract a controversial paper, Douglas Zipes, the editor-in-chief of HeartRhythm, has written a rare, highly pointed editorial defending the publication process. ”If one disagrees with facts/statements in a publication,” writes Zipes, “there is a well-defined approach that can begin with a letter to the editor or submission of one’s own data for peer…
This content is exclusive to CardioExchange. To continue reading, please log in or request an invitation.
Douglas Zipes, the editor of Heart Rhythm, said the journal will not retract a controversial paper that has raised new safety concerns about St. Jude’s embattled Riata leads. On Friday, as electrophysiologist Wes Fisher told CardioExchange, St. Jude issued a press release alleging numerous mistakes and oversights in an article by Robert Hauser published online in Heart Rhythm linking the company’s Riata…
This content is exclusive to CardioExchange. To continue reading, please log in or request an invitation.
CardioExchange welcomes this guest post from Dr. Westby Fisher, an electrophysiologist practicing at NorthShore University HealthSystem in Evanston, Illinois, and a Clinical Associate Professor of Medicine at University of Chicago’s Pritzker School of Medicine. This piece originally appeared on his blog, Dr. Wes. St. Jude Medical, a widely-used manufacturer of implantable cardiac devices, finds they have a bit of a…
This content is exclusive to CardioExchange. To continue reading, please log in or request an invitation.
Electrical malfunctions, not externalized conductors, may be the cause of 20 or more deaths associated with the troubled Riata ICD leads from St. Jude Medical, according to a new report published online in Heart Rhythm. Robert Hauser and colleagues at the Minneapolis Heart Institute searched the FDA’s MAUDE database and found 22 deaths caused by Riata or…
This content is exclusive to CardioExchange. To continue reading, please log in or request an invitation.
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…
This content is exclusive to CardioExchange. To continue reading, please log in or request an invitation.
