Heart Rhythm

Hearts should have normal rhythm to their beats, but when these beats are out of synch, it causes inefficient pumping of blood. Irregular heart arrhythmias occur when the electrical signals that coordinate the heart's beats do not work properly. This can cause beats that are too fast (tachycardia), or too slow (bradycardia). Tachycardias include atrial fibrillation (AFib), supraventricular tachycardia, ventricular fibrillation, and ventricular tachycardia (VT). Bradycardias include sick sinus syndrome and conduction block. Electrophysiology arrhythmia treatments include medications, life style changes, and the EP lab interventions of catheter ablation, and implantable pacemakers or defibrillators.

Boston Scientific begins clinical trial of ACUITY X4 LV pacing leads and RELIANCE 4-FRONT ICD leads

Boston Scientific Corporation has conducted the first implant in the clinical trial of the next generation ACUITY™ X4 left-ventricular (LV) pacing leads and RELIANCE™ 4-FRONT defibrillation (ICD) leads. The clinical trial is designed to establish the safety and effectiveness of both lead families and is intended to support U.S. Food and Drug Administration (FDA) approval of these devices.

April 24, 2014

HRS.14: Latest tech, case management & many attendees

Preregistration attendance for Heart Rhythm Society 2014 has increased significantly compared with last year in all demographic categories, said John D. Day, MD, chair of the scientific session program committee, with notable bumps in international physicians and allied professionals.

April 21, 2014

Medtronic announces CE Mark and European launch of first implantable cardioverter-defibrillator system to allow for full-body MRI scans

Medtronic today announced CE (Conformité Européenne) Mark and European launch of the Evera MRI(tm) SureScan implantable cardioverter-defibrillator (ICD) System, the first and only ICD system approved for magnetic resonance imaging (MRI) scans positioned on any region of the body. The Medtronic Evera MRI ICD is not approved in the United States.

April 12, 2014

Nearly 80 Percent of cardiologists say ischemic stroke risk reduction is their primary goal in non-valvular atrial fibrillation treatment, new survey shows

RIDGEFIELD, Conn., March 28, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced results from a new survey of cardiologists to understand their perceptions about anticoagulation, stroke risk reduction and goals for non-valvular atrial fibrillation (NVAF) therapy when prescribing warfarin or a novel oral anticoagulant. The online survey, conducted by Harris Poll on behalf of BIPI, included 300 licensed U.S. cardiologists who treat at least five NVAF patients per month.

April 1, 2014

St. Jude Medical announces start of European post-approval trial for Nanostim leadless pacemaker

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the first enrollments in the company’s LEADLESS Pacemaker Observational Study evaluating the Nanostim™ leadless pacing technology. The Nanostim pacemaker received CE Mark in 2013, and post-approval implants have occurred in the UK, Germany, Italy, Czech Republic, France, Spain, and the Netherlands.

March 21, 2014

Boston Scientific announces CE Mark approval and first implants of Ingevity MRI pacing leads

Boston Scientific Corporation (NYSE: BSX) announces CE Mark approval and European market launch of the INGEVITY™ family of magnetic resonance imaging (MRI) compatible pacing leads. Pacing leads are insulated wires that connect an implantable pacemaker to the heart for treatment of bradycardia, a condition in which the heart beats too slowly.  Pacemakers work in conjunction with leads to sense and stimulate (or pace) the heart.

March 15, 2014

FDA approves first ICD to be evaluated in US clinical trials for use in MRIs

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.

March 15, 2014

Report says less favorable Pradaxa data withheld from FDA

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.

February 26, 2014

Around the web

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."

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