Clinical

This channel newsfeed includes clinical content on treating patients or the clinical implications in a variety of cardiac subspecialties and disease states. The channel includes news on cardiac surgery, interventional cardiology, heart failure, electrophysiology, hypertension, structural heart disease, use of pharmaceuticals, and COVID-19.   

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The U.S. Food and Drug Administration (FDA) has granted pre-market approval (PMA) for the Globe Pulsed Field Ablation (PFA) System, and 510(k) clearance for both the Globe introducer sheath and the Globe Pulsed Field System mapping software from Kardium Inc. This add another competitor in the growing U.S. PFA market to treat atrial fibrillation (AFib).

FDA clears Kardium Globe pulsed field ablation system

It is the only integrated system that combines high-density mapping and PFA in a single device. The system uses a 122-electrode spherical array to enable rapid, single-shot pulmonary vein isolation, helping to streamline workflows.

Toby Rogers, MD, PhD, associate professor of medicine Georgetown University, and interventional cardiologist at MedStar Heart and Vascular Institute Structural Heart Disease program, explains how the transcatheter electrosurgical procedures for transcaval access, SESAME, LAMPOON and BASILICA has helped large numbers of patients receive transcatheter heart valves who otherwise would have been disqualified due to anatomical issues.

Advances in electrosurgical techniques have helped thousands of transcatheter valve patients

Toby Rogers, MD, associate professor of medicine at Georgetown University and an interventional cardiologist at MedStar, explains how electrosurgical procedures for transcaval access have helped large numbers of patients receive transcatheter heart valves who otherwise would have been disqualified due to anatomical issues. 
 

the words "FDA recall" on a board

Update: FDA announces new Class I recalls due to safety issue with Medtronic catheters

More than 100,000 surgical devices are included in these recalls, and there may be "limited product availability" in the months ahead. The FDA first warned the public about this issue in August. 

Radiologist to lead new research on blast injuries in service members

The study, which will be funded by a $2.3 million grant from the U.S. Department of Defense, will harness the power of advanced MRI technology to visualize the brain in a way that has not previously been possible.  

Report: HHS suppresses major study that found link between alcohol and cancer

Speaking to Vox, the authors said they were informed the results of their major study commissioned by the Department of Health and Human Services (HHS) would not be published. However, there appeared to be nothing wrong with the methodology of the analysis.

Philips introduced a new cardiac monitoring telemetry platform designed to help address critical challenges in healthcare, including staff shortages and alarm management. A key component of the solution is the next-generation Telemetry Monitor 5500 is an integrated central monitoring unit solution that integrates the telemetry device platform.

Philips launches smart telemetry platform for cardiac monitoring

Care teams can face alarm and cognitive overload, with an average of 350 alarms going off per patient per day. But Philips' new telemetry platform streamlines alarm management, delivers data-driven insights and automates clinical tasks—with operational simplicity and networking options.

Pei-Ni Jone, MD, FASE, director, echocardiography laboratory, Lurie Children’s Hospital Heart Center, professor of pediatric cardiology, Northwestern University Feinberg School of Medicine, member of the American Society of Echocardiography (ASE) Board, and the chair of the ASE Pediatric and Congenital Heart Disease Council Steering Committee, explains how 3D echo is being used to better plan, guide and followup in congenital cardiac surgery.

3D echo guidance seeing increasing use in congenital heart surgery

Pei-Ni Jone, MD, FASE, director, echocardiography laboratory, Lurie Children’s Hospital Heart Center, member of the American Society of Echocardiography (ASE) Board, explains how 3D echo is being used to better plan, guide and follow up in congenital cardiac surgery.

Stereotaxis MAGIC SWEEP electrophysiology catheter

First commercial robotically navigated, high-density EP mapping procedures performed in US

The Stereotaxis MAGiC Sweep gained FDA clearance in July and its first commercial use was announced this week.

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