BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the Food and Drug Administration (FDA) has approved the expansion of BIOTRONIK's ongoing ProMRI® trial. The new phase of the trial (Phase C) will study the company's ProMRI® technology in implantable cardioverter-defibrillator (ICD) devices. BIOTRONIK is the only company in the world with an ICD that is approved for investigational use in an MRI (magnetic resonance imaging) scanner. The ongoing ProMRI® study is the first step in making this standalone technology available in the United States.

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.

Continuing its leadership in advanced pacing technology and device miniaturization, Medtronic, Inc. (NYSE: MDT), today announced the first U.S. implant of the world's smallest pacemaker: the Micra(tm) Transcatheter Pacing System (TPS). The device was successfully implanted at NYU Langone Medical Center by Larry Chinitz, M.D., director of the Heart Rhythm Center at NYU Langone Medical Center in New York City, as part of the Medtronic global pivotal clinical trial. The Micra TPS is an investigational device worldwide.

Fourteen-year-old Monroeville, Ala., teenager Christian Quarles is the first state resident to receive the Boston Scientific S-ICD® System, the world’s first and only commercially available subcutaneous implantable defibrillator for the treatment of patients at risk for sudden cardiac arrest.

The Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center will host EP Live—a two-day, intensive educational meeting targeting practicing electrophysiologists from across the globe, electrophysiology (EP) fellows in training, general cardiologists, cardiac surgeons with an interest in treating complex arrhythmias and primary care physicians. The meeting consists of four sections: atrial fibrillation ablation, ventricular tachycardia ablation, devices and new technologies. 

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.

A subcommittee of the Heart Rhythm Society (HRS) published a list of five treatments and procedures electrophysiologists should avoid in patients with arrhythmias. The five “don’ts” are available on the HRS website.

eCardio Diagnostics, a leader in remote arrhythmia monitoring services, today announced the opening of its second Independent Diagnostic Testing Facility (IDTF) in San Francisco, California.