Electrophysiology & Arrhythmia

The FDA approved the Evera MRI Surescan implantable cardioverter defibrillator (ICD) as the first ICD system for use with MRI scans. The system is expected to be available this month.

After six months of nonsurgical implantation with an active-fixation leadless cardiac pacemaker, 90 percent of patients had an acceptable pacing threshold and sensing amplitude, according to a prespecified analysis of an ongoing study. In addition, 6.7 percent of patients had device-related serious adverse events.

The American College of Cardiology (ACC) announced it plans on launching two clinical registry programs to track outcomes in patients with atrial fibrillation. The registries will be part of the National Cardiovascular Data Registry, which currently includes eight cardiovascular data registries.

Johnson & Johnson will give outside researchers access to clinical data on diagnostics and medical devices through Yale University, but the largesse applies only to products approved in 2014 or later. That makes the ThermoCool SmartTouch catheter available for scrutiny, the New York Times reports. 

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. 

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.

Bloomberg News reported that Boehringer Ingelheim provided the FDA with one analysis showing a lower rate of fatal bleeding events in patients treated with dabigatran (Pradaxa) than was found in a second analysis that the company chose not to share.

More than 2,000 patients in the U.S. have filed suits against Boehringer Ingelheim over its oral anticoagulant dabigatran (Pradaxa). The company confirmed the number to Reuters after a German newspaper initially reported the total.

The June issue of Pharmaceuticals Monthly explores the delay in the approval of apixaban (Eliquis) by the FDA. “Apixaban shows how a review that seems, on its face, like it should be a quick and clean affair can become derailed by issues that, but for the agency’s own public disclosures post-approval, would never see the light of day,” according to the article.

Vincent L. Gott, MD, professor emeritus at Johns Hopkins Heart & Vascular Institute in Baltimore, shares his experiences as a developer of the pacemaker in an interview with CNN. The feature is part of CNN’s “Life Works” series.