Guest Post: How Sure Can We Be About Optisure?

Editor’s Note: The following guest post is published with the permission of its author, Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. How Sure Can We Be About Optisure? by Edward J. Schloss, MD On March 24, St. Jude Medical announced the global launch…

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Guest Post: Case Report Of Durata Lead Failure Raises Fresh Concerns

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. Case Report Of Durata Lead Failure Raises Fresh Concerns by Edward J. Schloss, MD  A case report of a failed St. Jude Medical Durata…

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FDA Releases St. Jude Warning Letter

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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…

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Guest Post: New Questions Raised About Latest Generation St. Jude ICD Leads

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.  New Questions About Latest Generation ICD Leads From St. Jude by Edward J. Schloss A highly anticipated study analyzing failures of St. Jude Durata…

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Guest Post: FDA Clarifies Riata Imaging Recommendations

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. Additional clarity regarding yesterday’s St. Jude Riata/Riata ST imaging recommendations has arrived in the form of another FDA Safety Communication available at the…

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Guest Post: FDA Calls For X-Ray Screening Of Riata Leads And Additional Followup Studies

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. St. Jude’s troubled implantable defibrillator leads came under a fresh layer of scrutiny today with new FDA imaging recommendations and post-market study requirements. …

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Single Case Report Casts New Doubts About St. Jude Durata ICD Leads

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. As if on cue, just as the train pulled into the Nice-Ville station for this week’s Cardiostim 2012 meeting on the French Riviera, my…

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Robert Hauser, ICD Watchdog, Offers Viewpoint On Riata Controversy At HRS

Photo of Durata promotional truck at HRS courtesy of Dr. Wes

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. Robert Hauser, ICD Watchdog, Offers Viewpoint On Riata Controversy At HRS by Edward J Schloss MD The St. Jude Riata ICD lead controversy took…

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Guest Post: Shedding Light On Riata At The Heart Rhythm Society Meeting

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. Shedding Light On Riata At The Heart Rhythm Society Meeting by Edward J Schloss MD This morning in Boston, HRS 2012 sessions began with…

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Heart Rhythm Editor Douglas Zipes Defends Peer Review

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 the editor, Douglas Zipes, “there is a well-defined approach that can begin with a letter to the editor or submission…

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Guest Post: After an Unprecedented Request for a Retraction, A Close Look at the Data

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. After an Unprecedented Request for a Retraction, A Close Look at the Data by Edward J Schloss MD Last week, St. Jude Medical took…

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Round Two: Heart Rhythm Editor Rejects St Jude Request to Retract Riata Paper

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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 reported here) 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…

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St. Jude Seeks Retraction of Hauser Article On Riata Leads

St. Jude Medical is seeking the retraction of an article by Robert Hauser in Heart Rhythm linking the company’s Riata and Riata ST leads to 20 or more deaths. In a press release (see below) issued on Friday afternoon, St. Jude alleges numerous mistakes and oversights in the Hauser paper. In a brief statement to CardioBrief, Hauser wrote:…

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St Jude Withdraws Older LV CRT Leads From Market

St. Jude Medical today issued an advisory about its QuickSite and QuickFlex Left-Ventricular (LV) Leads, which connect to Cardiac Resynchronization (CRT) devices. The company said it would no longer sell these leads, but that it had received no reports of death or serious injury associated with the problem. The problem with the LV leads closely parallels…

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Guest Post: Lessons from the Riata Recall– Part III

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. Lessons from the Riata Recall– Part III by Edward J Schloss MD In two earlier posts on Cardiobrief (here and here), I have written…

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20 Deaths Linked to New Problem with Riata Leads

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…

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Software Tool Could Provide Early Warning of ICD Lead Failure

In recent years defects in ICD leads have caused recalls and provoked broad concerns among health care 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…

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Guest Post: More Lessons From the Riata ICD Lead Recall

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Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. This post is longer and far more technical than most of the content published on CardioBrief. Due to the extraordinary nature of the…

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Guest Post: What Are the Lessons of the Riata ICD Lead Recall?

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. What Are the Implications of the Riata ICD Recall? by Edward J. Schloss, MD This week the New England Journal of Medicine published an…

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