March 21st, 2013
FDA Panel Gives Tepid Endorsement to Abbott’s MitraClip
Larry Husten, PHD
The FDA’s Circulatory System Devices advisory panel gave a tepid endorsement to Abbott Laboratories’ MitraClip device on Wednesday. The panel met to evaluate use of the novel device in patients with significant symptomatic mitral regurgitation (MR) who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing […]
October 16th, 2012
FDA Review Raises Safety Concerns About Mipomersen
Larry Husten, PHD
An FDA review raises a number of potentially significant safety concerns about the cholesterol-lowering drug mipomersen. The review appears ahead of a Thursday meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to evaluate Genzyme’s new drug application (NDA) for use of the drug as an adjunct to maximally tolerated lipid-lowering medications and diet to reduce […]
May 23rd, 2012
FDA Advisory Committee Recommends Against ACS Indication for Rivaroxaban
Larry Husten, PHD
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted today against adding an indication for acute coronary syndromes (ACS) to the label of the anticoagulant rivaroxaban (Xarelto). The vote was 6 to 4 against approval, with 1 abstention. The advisory panel spent most of the day trying to reconcile diametrically opposed views of the pivotal ATLAS ACS 2-TIMI […]
NEJM Journal Watch — Recent Cardiology Articles- Persistent Symptoms After Valve Replacement for Severe Aortic Stenosis
- Is Diltiazem Safe in Patients with AF Taking Apixaban or Rivaroxaban?
- Does Lowering High Childhood Lipid Levels Prevent Adverse Cardiovascular Events in Adulthood?
- Self-Expanding Supraannular Valve vs. Balloon-Expandable Valve in TAVR for Small Aortic Annulus
- A New TAVR Prosthesis for Aortic Regurgitation Shows Promise