Daiichi Sankyo Company, Limited today announced data from a subgroup analysis of the phase 3 ENGAGE AF-TIMI 48 study, that explores the relationship between edoxaban dose, concentration and anti-factor Xa activity in patients with non-valvular atrial fibrillation (NVAF). The analysis also compared rates of major bleeding and efficacy outcomes [stroke and systemic embolic events (SEE)] of edoxaban versus warfarin, stratified by dose reduction status.

Meet retired electrophysiologist David Mann, MD, not to be confused with all the other doctors with the same name. Except unfortunately for him, he was, and in the one of the thorniest places imaginable—the Centers for Medicare & Medicaid Services’ Open Payments System. 

St. Jude Medical, Inc., a global medical device company, today announced CE Mark approval and first use of the FlexAbility Ablation Catheter, a novel ablation technology used by electrophysiologists for the treatment of cardiac arrhythmias. Designed with feedback from physician thought-leaders around the world, the FlexAbility catheter combines a unique, irrigated flexible catheter tip with a state-of-the-art handle and catheter design. The next-generation flexible tip technology was designed to reduce complications associated with ablation procedures through its ability to bend and conform to the cardiac anatomy, decreasing the amount of pressure distributed to a patient’s heart wall while simultaneously increasing the stability of therapy delivery.

Medtronic and Lifetech Scientific Corporation today announced an expansion of their strategic alliance to include jointly produced Lifetech pacemakers manufactured in and for China.

Bristol-Myers Squibb Company and Pfizer Inc.  today announced that the first patient has been enrolled into a Phase IV clinical trial called EMANATE (Eliquis evaluated in acute cardioversion coMpared to usuAl treatmeNts for AnTicoagulation in subjEcts with NVAF) assessing the effectiveness and safety of Eliquis in patients with nonvalvular atrial fibrillation (NVAF) undergoing cardioversion.

Researchers at Cedars-Sinai Heart Institute in Los Angeles tested a “biological pacemaker” in pig hearts using gene therapy. The approach is at least three years away from human trials, the New York Times reports.

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to idarucizumab, an investigational fully humanized antibody fragment, or Fab, being studied as a specific antidote for Pradaxa (dabigatran etexilate mesylate).

Medtronic, Inc. (NYSE: MDT), today announced CE (Conformité Européenne) Mark and commercial launch of the Advisa and Ensura SR MRI(tm) SureScan single chamber pacemaker devices in Europe. Both pacemakers are approved for magnetic resonance imaging (MRI) scans positioned on any region of the body. These devices are not approved in the United States.