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New Enrollment in FAME II Halted After Interim Analysis Shows Benefits of FFR
Following a positive interim analysis showing that fractional flow-reserve-guided PCI was superior to optimal medical treatment, an independent Data and Safety Monitoring Board (DSMB) has recommended...
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St Jude Medical Statement on the Riata ICD Lead Summit
In response to the guest post summarizing the Riata ICD Lead Summit, St. Jude Medical sent the following statement to CardioBrief: We recognize that the phenomenon of externalized conductors presents a...
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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...
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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...
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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...
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Round Two: Heart Rhythm Editor Rejects St Jude Request to Retract Riata Paper
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...
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Guest Post: After an Unprecedented Request for a Retraction, A Close Look at...
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...
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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...
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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...
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St Jude CEO Spills The Beans On PFO Closure Trial
(Updated at bottom with statement from St. Jude Medical) Dan Starks, the CEO of St Jude Medical, stated during a quarterly earnings call last week that results of the RESPECT trial of PFO closure for...
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FDA Releases St. Jude Warning Letter
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...
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Should Physicians Be Business Partners With Medical Device Salesmen?
Should a Florida cardiologist co-own a business running frozen yogurt shops with a medical device salesman? That’s the question raised by reporter John Dorschner in a story posted by the Miami Herald...
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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...
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Novel Leadless Pacemaker Makes Debut At HRS 2013
First results in human patients of a novel leadless pacemaker were presented last week at the HRS meeting in Denver by Vivek Reddy. Pacemaker leads are the most common source of complications...
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Realistic Expectations For New ‘Breakthrough’ Blood Pressure Technology
Early trials of renal denervation, the innovative new catheter-based blood pressure lowering technology, have resulted in extremely impressive drops in systolic blood pressure in the range of 30 mm...
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CardioMEMS Heart Failure Device Gets Mixed Reception From FDA Advisory Panel
The FDA’s Circulatory System Devices Panel sent a mixed message to the FDA today about CardioMEMS Champion HF Pressure Measurement System. The small implantable device provides provides daily...
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First Leadless Pacemaker Gains Approval In Europe
St. Jude Medical announced on Monday that the world’s first leadless pacemaker had gained CE Mark approval in Europe. The company also announced that it was buying Nanostim, the company that developed...
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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...
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The Walking Dead: Renal Denervation In Europe Just Can’t Be Stopped
Earlier this year the only large, well-designed trial of renal denervation– the once highly-promising catheter-based technology that was widely expected to “cure” difficult cases of resistant...
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FDA Approves Novel Implanted Sensor To Monitor Heart Failure
The FDA announced today that it had approved the CardioMEMS Champion HF System. The small implantable device provides daily pulmonary artery pressure measurements to guide physicians in their treatment...
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Fractional Flow Reserve Gains Support in Stable CAD and NSTEMI
In recent years interventional cardiologists have started to use a new catheter technique, called fractional flow reserve (FFR), in an attempt to assess which blocked vessels might benefit from a...
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