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…
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…
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…
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…
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. …
New ICD Lead Technology Creates New Set of Problems: A Perspective From One Electrophysiologist
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. Why I Don’t Like DF-4: A Personal Perspective by Edward J Schloss MD Since the first human implantable cardioverter defibrillator (ICD) implant in 1980,…
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…
Robert Hauser, ICD Watchdog, Offers Viewpoint On Riata Controversy At HRS
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…
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…
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:…
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…
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…
Guest Post: More Lessons From 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. This post is longer and far more technical than most of the content published on CardioBrief. Due to the extraordinary nature of the…
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…
Court dismisses complaint against Medtronic over Fidelis leads
A US District Court has dismissed a case against Medtronic over the Fidelis lead failures. The decision follows the significant precedent-setting Supreme Court decision last year in Riegel v Medtronic. You can read the Wall Street Journal story or the Medtronic press release by clicking below….
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