CardioExchange Archive

STOP-AF: The STOP-AF trial compared a novel cryoballoon ablation technology with antiarrhythmic drug (AAD) therapy in 245 AF patients who had failed at least one AAD. Treatment success was achieved in 69.9% of cryoballoon patients versus 7.3% of AAD patients, a highly significant difference (p<0.001). Phrenic nerve palsy occurred in 13.5% of cryoballoon patients and 7.3% of AAD patients. The study was presented on Monday at the ACC.

FDA to Review ACCORD Data: Following the presentation and publication in the New England Journal of Medicine on Sunday of ACCORD, which found no benefit for fenofibrate when given on top of statins in patients with type 2 diabetes, the FDA announced that it would review data from the trial, but stated that “at this time, FDA has made no new conclusions or recommendations regarding the combination use of simvastatin or other statin drugs and fenofibrate.”

Boston Scientific Suspends ICD Sales: Boston Scientific announced on Monday that it was suspending all sales of its ICDs and CRT-Ds. The suspension took place after the company “determined that some manufacturing process changes were not submitted for approval” to the FDA.

Medtronic Investigated by U.S. Attorney: In its most recent quarterly report, Medtronic disclosed that it was under investigation by the U.S. Attorney’s office in Massachusetts over the company’s relationship to cardiologists at the Lahey Clinic. (More details are available at CardioBrief.)