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.

FDA announces recall of cryoablation catheters after multiple injuries, including 4 deaths
Boston Scientific is recalling the catheters associated with its POLARx Cryoablation System due to a heightened risk of esophageal injury. The FDA has ruled that this a Class I recall.
Cardiologists perform world’s first leadless LBBAP procedures with Abbott pacemaker
The first-in-human procedures were performed in Prague with the investigational Aveir CSP leadless pacemaker system.
President of medical device company resigns over conduct allegations after 7 months in role
Joseph C. Wright, a longtime Merit Medical employee, resigned after unspecified allegations regarding his conduct were brought to light. He was named the company's new president back in May.
FDA and Boston Scientific issue urgent alert about pacemaker failures following 2 deaths
The U.S. Food and Drug Administration issued the recall notice for more than 200,000 pacemakers because a battery issue could lock the device in safe mode.
Treating AFib patients with TAVR still linked to elevated risks
While the technology and techniques associated with TAVR have advanced over the years, treating patients who present with baseline atrial fibrillation is still associated with certain risks.

FDA approves shorter, third-gen cryoballoon

The FDA approved Medtronic’s latest generation cryoablation catheter for treating patients with paroxysmal atrial fibrillation. The Arctic Front Advance ST also received CE mark in Europe for a broader indication.

May 12, 2015

Boston Scientific announces scheduled presentations at Heart Rhythm Society 2015

Boston Scientific today announced that key data from 42 abstracts will be featured at the 36th Annual Scientific Sessions of the Heart Rhythm Society (HRS) in Boston on May 13-16.

May 11, 2015

FDA clears Greatbatch’s sutureless pacing lead

The FDA gave Greatbatch Medical the green light to market a sutureless myocardial pacing lead for ventricular pacing and sensing.

May 8, 2015

Pulmonary-vein isolation alone suffices for persistent AF

More is not better when it comes to catheter ablation to treat persistent atrial fibrillation. A randomized controlled clinical trial found additional ablation did not improve outcomes, a result that may prompt a revision in guidelines.

May 6, 2015

Medtronic to unveil first-of-its-kind clinical data for cardiac therapies at Heart Rhythm 2015

Medtronic plc today announced its schedule of notable clinical studies that will be presented at Heart Rhythm 2015, the Heart Rhythm Society's 36th Annual Scientific Sessions in Boston, including two late-breaking clinical trials featuring the Evera MRI® SureScan® implantable cardioverter-defibrillator (ICD) System and Micra® Transcatheter Pacing System (TPS).

May 6, 2015

Off-label use of Lariat device associated with death, urgent cardiac surgery

A systematic review of databases found that off-label use of the Lariat snare device for left atrial appendage exclusion was associated with adverse events, including death and urgent cardiac surgery.

May 4, 2015

CEO & HRS Leader’s Strategy: Listen, Ask, Recruit & Step Back

As an early career electrophysiologist, Richard I. Fogel, MD, learned to raise his hand when projects needed a captain. Now he’s CEO of the St. Vincent Medical Group in Indianapolis and president of the Heart Rhythm Society (HRS). His formula? Listen, ask good questions, surround yourself with talented people and let them do their jobs, he explains in a Q&A with Cardiovascular Business.

April 27, 2015

FDA grants priority review to Boehringer Ingelheim’s biologics license application for idarucizumab

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for idarucizumab, which is being investigated to specifically reverse the anticoagulant effect of dabigatran, the active ingredient in Pradaxa® (dabigatran etexilate mesylate) in patients needing emergency intervention or experiencing an uncontrolled or life-threatening bleeding event. The idarucizumab BLA will be reviewed under Accelerated Approval and is the first review for a reversal agent in the novel oral anticoagulant (NOAC) class. Currently, no NOACs have an approved reversal agent.

April 24, 2015

Around the web

Radiology Business

Key takeaways from RSNA 2024 for AI, CT, MRI and the radiology staffing shortage

Several key trends were evident at the Radiological Society of North America 2024 meeting, including new CT and MR technology and evolving adoption of artificial intelligence.

Health Imaging

Use of AI opportunistic screening in CT for cardiovascular disease

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Heart Rhythm

FDA announces recall of cryoablation catheters after multiple injuries, including 4 deaths

Cardiologists perform world’s first leadless LBBAP procedures with Abbott pacemaker

President of medical device company resigns over conduct allegations after 7 months in role

FDA and Boston Scientific issue urgent alert about pacemaker failures following 2 deaths

Treating AFib patients with TAVR still linked to elevated risks

Around the web