–There’s no hard evidence the Sentinel Cerebral Protection System reduces stroke in TAVR. Here’s how to get a second generation medical product or add-on product approved: show that the original device isn’t nearly as safe and effective as believed back in, you know, the dark ages before the new product showed up. Until now proponents…
More Questions Raised About Boehringer Ingelheim’s Pradaxa
July 23, 2014 by 1 Comment
Once again dabigatran (Pradaxa) has raised the wrath of the critics. Several articles and an editorial published today in The BMJ raise more questions and concerns about the drug, which is the first of the new oral anticoagulants. Relying on new evidence along with previously disclosed data, Deborah Cohen, the investigations editor for The BMJ, casts doubt on the reliability…
Yet Another Delay For Boston Scientific’s Watchman Device
June 17, 2014 by Leave a Comment
Boston Scientific hopes the third time will be the charm. The company disclosed on Tuesday yet another obstacle in the path to approval for its novel Watchman left atrial appendage closure device for the prevention of stroke in patients with atrial fibrillation. Although it has already been before two FDA advisory panels, the company said…
Warfarin Benefits Extended To Patients with Chronic Kidney Disease
March 4, 2014 by Leave a Comment
Anticoagulation is a cornerstone of therapy for atrial fibrillation because it lowers the heightened risk for stroke in this population. People with chronic kidney disease are also at increased risk for stroke, but the benefits of anticoagulation are less clear in this group, and anticoagulation is used less often in AF patients who have CKD….
New Anticoagulant From Daiichi Sankyo Works Well In AF Patients
November 19, 2013 by Leave a Comment
Edoxaban, a direct oral factor Xa inhibitor under development by Daiichi Sankyo, is the latest in the series of new oral anticoagulants seeking to take over the troubled role of warfarin in clinical practice. The results of ENGAGE-AF-TIMI 48 were presented at the American Heart Association meeting in Dallas and published simultaneously in the New England Journal of Medicine. The results of the trial were…
Growing Popularity Of Dabigatran Leads To Increased Complications
June 7, 2012 by 1 Comment
Since its approval in the United States in October 2010 dabigatran (Pradaxa) has been prescribed 3.2 million times to more than 600,000 patients with nonvalvular atrial fibrillation (AF), according to its manufacturer, Boehringer Ingelheim. The company also announced that, based on the pivotal RE-LY trial, the “Clinical Studies” section of the drug’s prescribing information now…
2011 in Review: Rivaroxaban, Sapien, Mark Midei, Conflicts of Interest, and Much More
December 31, 2011 by 4 Comments
Here’s a completely personal review of the past year in cardiology. Please write a comment if you strongly agree, disagree, or think something is missing. Drug of the Year: Rivaroxaban (Xarelto)– Despite a highly negative review from FDA reviewers, rivaroxaban gained FDA approval for the coveted stroke prevention in AF indication. The drug was approved…
Recent Comments