The FDA has approved rivaroxaban (Xarelto, Bayer HealthCare/Janssen Pharmaceuticals) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF).

Combining clopidogrel and aspirin in patients who could not tolerate warfarin showed benefit, according to a study published Nov. 1 in Annals of Internal Medicine. However, the researchers said that they could not rule out the fact that this combination could have either no benefit or a very small harm in some patients. An editorialist added that as more novel anticoagulants get approved, the drug class may outshine dual-antiplatelet therapy.

The global electrophysiology device market, valued at $1.1 billion in 2010, is set to expand 6 percent, to reach $1.6 billion by 2017, according to an October report released by GlobalData, an industry analysis firm. The company said that the growing number of patients diagnosed with arrhythmias and the adoption of newer, robotic and magnetic navigation systems and drugs to treat atrial fibrillation will likely be the driver of this market growth.

When the FDAs Circulatory System Device panel meets Oct. 27, panelists will question the safety of Medtronics Ablation Frontiers Cardiac Ablation System, and discuss the overall risk/benefit profile of the device. In a previously released report, the FDA noted that the primary efficacy endpoints were met during the trial evaluating the device, but safety endpoints were not, making the agency question the devices safety. During the meeting, the FDA said it will be seeking comments from committee members on these safety considerations.

St. Jude Medical has reported positive sales and net earnings for the 2011 third quarter, which ended Oct. 1, compared with the same time period in 2010.

Despite receiving praise from the FDAs Cardiovascular and Renal Drug Advisory Committee, the anticoagulant rivaroxaban (Xarelto, Bayer/Johnson & Johnson) is now getting scrutiny from Public Citizen. In a letter dated Oct. 20 and sent to the FDA, Public Citizen questioned the safety and efficacy of the drug and urged that it not be approved to prevent strokes and systemic embolism in patients with atrial fibrillation (AF).

Laser lead extraction is a safe and effective treatment for patients 80 years old and older, according to a study published in the October issue of Circulation: Arrhythmia & Electrophysiology. While the findings may help physicians in the management of elderly patients, the authors cautioned that further research is needed to make results more generalizable.

Permanent atrial fibrillation (AF) patients may be at a loss when it comes to quality of life. A study published in the Oct. 18 issue of the Journal of American College of Cardiology showed that rate control did not affect or improve quality of life; however, symptoms, female sex, older age and disease severity were shown to worsen quality of life in these patients.