In an unusual reversal of a statement it made two days ago, Boston Scientific announced this afternoon that it would present all three co-primary endpoints of the PREVAIL clinical trial this Saturday at the American College of Cardiology scientific sessions in San Francisco. The PREVAIL trial, which was designed to confirm the safety and efficacy of the Watchman left atrial appendage…
ACC Prevails Upon Boston Scientific To Present More Data At Late Breaker
March 6, 2013 by Leave a Comment
FDA Approves Second Generation MRI-Friendly Pacemaker System
February 13, 2013 by Leave a Comment
Medtronic announced today that the FDA had approved its Advisa DR MRI SureScan, a next generation pacemaker system specifically designed and tested for use with MRI scanners. The system, which Medtronic said would be launched immediately, includes the Advisa MRI device and two CapSureFix MRI SureScan leads. Click here to read the full post on Forbes….
Rivaroxaban Effective In Medically Ill Patients But At High Bleeding Cost
February 7, 2013 by Leave a Comment
The recent arrival of novel oral anticoagulants has provided important new options for venous thromboembolism (VTE) treatment and prevention. New indications for these drugs have been granted for patients with atrial fibrillation and following orthopedic surgery. But an additional indication, for acutely ill medical patients at risk for VTE, does not appear likely in the…
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,…
Trials Of Niacin And Atrial Fibrillation Device Will Headline American College Of Cardiology Program
January 22, 2013 by Leave a Comment
Two big trials will highlight this year’s American College of Cardiology meeting in March in San Francisco. First is the PREVAIL trial testing Boston Scientific‘s long-anticipated Watchman left atrial appendage closure device for stroke prevention in patients with atrial fibrillation. Second is the detailed presentation of the controversial failed HPS2-THRIVE trial of extended-release niacin and laropiprant. Read my…
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…
Richard Lehman On ICDs In Clinical Practice And Serelaxin For HF
January 7, 2013 by Leave a Comment
This week in CardioExchange Richard Lehman is not quite as funny as most weeks (perhaps he’s still recovering from New Years’ celebrations?), but he has some interesting and useful comments on a JAMA study comparing real world patients garcinia cambogia plant uses in registries to patients in clinical trials and an impressive Lancet study testing the role of…
What’s Next for the iPhone ECG Following Regulatory Clearance?
January 4, 2013 by 2 Comments
from Medical Device and Diagnostic Industry: What’s Next for the iPhone ECG Following Regulatory Clearance? The user base and functionality of mobile ECG technology is set to expand. “After recently winning FDA clearance and CE Mark certification, the iPhone ECG from AliveCor (San Francisco, CA), is poised to kickstart a disruption of the traditional ECG…
FDA Approves Eliquis (Apixaban) For Stroke Prevention In AF
December 28, 2012 by 4 Comments
The FDA has finally approved apixaban (Eliquis, Bristol Myers Squibb and Pfizer) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The action comes after the widely-anticipated drug had been plagued by delays at the FDA but well before the PDUFA deadline of March 17, 2013. Eliquis is the latest…
Pradaxa To Be Contraindicated In Patients With Mechanical Heart Valves
December 18, 2012 by 1 Comment
Boehringer Ingelheim is starting to inform physicians about a new contraindication for its oral anticoagulant drug Pradaxa (dabigatran). The company has told investigators in trials utilizing dabigatran that it will shortly be sending a “Dear Doctor Letter,” also known as a Direct Healthcare Professional Communication (DHPC), to healthcare professionals. The letter will inform physicians that…
Boehringer Ends Phase 2 Trial Of Dabigatran In Mechanical Valve Patients
December 12, 2012 by 2 Comments
Boehringer Ingelheim today announced that it had discontinued a phase 2 trial of its anticoagulant drug dabigatran (Pradaxa) in patients with mechanical heart valves. As reported here in October, the company had previously terminated one arm of the study after an interim review of the data by the trial’s Data Safety Monitoring Board The RE-ALIGN trial was an open-label,…
No Surprise: Smoking and Sudden Cardiac Death Closely Tied
December 11, 2012 by 3 Comments
Although cigarette smoking has long been linked to cardiovascular (CV) disease and sudden cardiac death (SCD), the precise contribution of smoking, and the effect of smoking discontinuation, on SCD has not been clear. Now a new report from the Nurses’ Health Study published in Circulation: Arrhythmia & Electrophysiology provides new clarity about the relationship between smoking…
BLOCK HF: A “Game Changer” For Cardiac Pacing
November 6, 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. Dr. Schloss was an investigator in the BLOCK HF trial. In what has been described as a “game changer” for the field of…
FDA Investigation Finds No Excess Bleeding Risk For Dabigatran
November 2, 2012 by 1 Comment
In its latest assessment of a highly controversial issue, the FDA has found no indication that bleeding rates for dabigatran (Pradaxa, Boehringer-Ingelheim) are any higher than the bleeding rates for warfarin. The FDA investigation was in response to the large number of post-marketing reports of bleeding in people taking dabigatran. Click here to for the…
Atrial Fibrillation: Radiofrequency Catheter Ablation And Antiarrhythmic Drug Therapy Compared
October 24, 2012 by Leave a Comment
A trial comparing radiofrequency catheter ablation (RFA) to antiarrhythmic drug therapy (AAD) as initial therapy for atrial fibrillation (AF) found no difference in the overall burden of AF between the groups. But the trial also turned up evidence supporting the use of RFA as an initial treatment strategy in some patients. In a paper published…
Setback For Trial Studying Dabigatran After Mechanical Valve Surgery
October 23, 2012 by 2 Comments
Despite the recent advent of novel oral anticoagulants, the much-maligned warfarin remains the only current option available for patients who have received a mechanical valve. Now the first trial to explore this indication for a newer oral anticoagulant has suffered a setback. Last year Boehringer Ingelheim announced the launch of the RE-ALIGN trial, a phase…
High Rate Of Warfarin Discontinuation Observed In Study
October 22, 2012 by Leave a Comment
One of the many potential problems with warfarin-based anticoagulant therapy is the poor rate of adherence and persistence among patients who are prescribed the drug. Now a new observational study published in Archives of Internal Medicine raises the possibility that the problem may be even worse than many may have previously suspected, as discontinuation rates in clinical…
Subcutaneous ICD Gains FDA Approval
September 28, 2012 by Leave a Comment
The FDA today approved the Subcutaneous Implantable Defibrillator (S-ICD) system from Cameron Health. The device is the first ICD that does not require a lead that connects directly to the heart and therefore does not need to be guided with x-ray fluoroscopy. Instead, the S-ICD lead is implanted along the bottom of the rib cage…
FDA Sets New Decision Date For Eliquis (Apixaban)
September 27, 2012 by Leave a Comment
The FDA will decide the fate of apixaban (Eliquis) by March 17, 2013. The new Prescription Drug User Fee Act (PDUFA) goal date was announced yesterday by the drug’s manufacturers, Pfizer and BristolMyers Squibb. The new drug application (NDA) for stroke prevention in atrial fibrillation has been delayed twice. Although the pivotal ARISTOTLE trial was…
Merck Returns To Cardiome All Rights To Atrial Fibrillation Drug Vernakalant
September 26, 2012 by Leave a Comment
Merck and Cardiome announced today that Merck was returning to Cardiome all marketing and development rights for the atrial fibrillation (AF) drug vernakalant. An intravenous formulation of vernakalant is marketed in Europe as Brinavess. It has not been approved in the United States, though it received a positive recommendation from the FDA’s Cardiovascular and Renal…
Apixaban (Eliquis) For Atrial Fibrillation Gets Positive European Recommendation
September 21, 2012 by 2 Comments
The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval for apixaban (Eliquis, Pfizer and BristolMyers Squibb) for atrial fibrillation (AF). The drug is already approved in Europe for the prevention of venous thromboembolic events (VTE) following hip or knee replacement surgery. The drug has not yet been approved in the United States. Here…
Updated Rhythm Device Guidelines Clarify And Expand CRT Criteria
September 11, 2012 by Leave a Comment
A newly released update of 2008 guidelines for device-based therapy of cardiac arrhythmias contains some much-needed clarification about indications for cardiac resynchronization therapy (CRT). The document was developed jointly by the American Heart Association, the American College of Cardiology, and the Heart Rhythm Society. Highlights of the documents include: The Class 1 recommendation for CRT…
News Briefs: Cholesterol Trends, AHA Late-Breakers, FDA Updates On Rivaroxaban And Heartware HVAD
September 7, 2012 by Leave a Comment
Cholesterol Trends The Centers for Disease Control issued a new report with the latest details about the prevalence of cholesterol screening and high blood cholesterol in US adults. Here is their summary of the key findings: …cholesterol screening increased from 72.7% in 2005 to 76.0% in 2009, whereas the percentage of those screened who reported…
ICD Investigation: DOJ Sends Resolution Model To Hospitals
August 30, 2012 by 1 Comment
Hospitals across the country received emails from the US Department of Justice on Thursday containing a proposed “Resolution Model” that will allow the hospitals to begin to settle the long-standing and much-feared DOJ investigation into improper Medicare billing for ICDs. The action appears to confirm an article, published earlier in August in Report on Medicare…
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