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 stent. Two studies presented at the European Society of Cardiology meeting in Barcelona offered new support for FFR, which has been slowly but surely gaining traction in the…
FDA Approves Novel Implanted Sensor To Monitor Heart Failure
May 28, 2014 by Leave a Comment
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 of NYHA Class III heart failure patients who have been hospitalized for heart failure in the previous year. The system consists of three parts: a small permanent sensor implanted…
The Walking Dead: Renal Denervation In Europe Just Can’t Be Stopped
May 21, 2014 by Leave a Comment
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 hypertension– failed spectacularly. Many hypertension experts believe that ultimately the technique will prove to be beneficial, but after the failure of Simplicity HTN-3 it is clear that there’s a great deal…
Guest Post: How Sure Can We Be About Optisure?
March 28, 2014 by 2 Comments
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…
First Leadless Pacemaker Gains Approval In Europe
October 15, 2013 by Leave a Comment
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 the innovative device. The FDA recently granted conditional approval for an Investigational Device Exemption (IDE) application and a pivotal clinical trial, St. Jude…
CardioMEMS Heart Failure Device Gets Mixed Reception From FDA Advisory Panel
October 9, 2013 by Leave a Comment
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 pulmonary artery pressure measurements to guide physicians in their treatment of patients with congestive heart failure. In December 2011 the same panel voted 9-1 that the device was safe, 7-3 that…
Realistic Expectations For New ‘Breakthrough’ Blood Pressure Technology
September 10, 2013 by Leave a Comment
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 Hg. These results have sparked a great deal of excitement in the hypertension community and stirred the interest of a multitude of medical device companies. Some…
Novel Leadless Pacemaker Makes Debut At HRS 2013
May 13, 2013 by Leave a Comment
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 associated with pacemakers today. The self-contained device is delivered via catheter to the right ventricle, to which it is attached with a fixation mechanism. The device…
Guest Post: Case Report Of Durata Lead Failure Raises Fresh Concerns
March 27, 2013 by Leave a Comment
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…
Should Physicians Be Business Partners With Medical Device Salesmen?
February 3, 2013 by Leave a Comment
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 yesterday: “Mark Sabbota, a Hollywood cardiologist, regularly implants $5,000 pacemakers in patients at Memorial hospitals in South Broward — generating, last year alone,…
FDA Releases St. Jude Warning Letter
January 16, 2013 by Leave a Comment
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…
St Jude CEO Spills The Beans On PFO Closure Trial
July 23, 2012 by 1 Comment
(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 crytpogenic stroke were “favorable” and that the full trial results will be presented in October at the TCT meeting in Miami. But his statement…
Single Case Report Casts New Doubts About St. Jude Durata ICD Leads
June 12, 2012 by 1 Comment
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
May 16, 2012 by Leave a Comment
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
April 13, 2012 by 3 Comments
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…
Round Two: Heart Rhythm Editor Rejects St Jude Request to Retract Riata Paper
April 10, 2012 by Leave a Comment
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…
St. Jude Seeks Retraction of Hauser Article On Riata Leads
April 6, 2012 by 3 Comments
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:…
St Jude Withdraws Older LV CRT Leads From Market
April 4, 2012 by Leave a Comment
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…
Guest Post: More Lessons From the Riata ICD Lead Recall
February 22, 2012 by 7 Comments
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…
St Jude Medical Statement on the Riata ICD Lead Summit
January 23, 2012 by 2 Comments
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 complex patient management scenario for physicians who may be able to visualize an anomaly, but it is important to remember that most leads with…
New Enrollment in FAME II Halted After Interim Analysis Shows Benefits of FFR
January 18, 2012 by 3 Comments
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 that patient enrollment in the ongoing FAME II trial be stopped. The news was announced by the trial sponsor, St. Jude Medical. FAME II (Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal…
Recent Comments