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.

Medtronic recalls data management software, urging healthcare providers to run update
The error caused incorrect glucose data to be displayed to clinicians. According to Medtronic, any treatment decisions or recommendations based on those data need to be revisited.
Catheters recalled due to defect—FDA highlights risk of stroke or brain damage
The recall was put in place after a hydrophilic coating was discovered on the inside of the devices. According to the FDA, patients treated with the catheters could face a number of significant risks.
Abbott shares safety concerns with millions of CGM sensors—7 deaths reported
Approximately 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors need to be replaced due to a risk of incorrect glucose readings. Abbott has received reports of 736 severe adverse events and seven deaths that may be related to this issue.
Cardiology groups share new recommendations for performing safe, effective cardiac ablations in ASCs
The timing of this new guidance from the Heart Rhythm Society and American College of Cardiology could not have been better—the document went live just as CMS finalized its decision to cover cardiac ablation procedures performed in ASCs.
Adjustable interatrial shunt for heart failure shows promise in first-in-human trial
Gregg Stone, MD, spoke to Cardiovascular Business about early data from the ATHENS-HF trial. Ten heart failure patients were treated with the adjustable device, and each implant was a success.

Medtronic recalls data management software, urging healthcare providers to run update

The error caused incorrect glucose data to be displayed to clinicians. According to Medtronic, any treatment decisions or recommendations based on those data need to be revisited.

Catheters recalled due to defect—FDA highlights risk of stroke or brain damage

The recall was put in place after a hydrophilic coating was discovered on the inside of the devices. According to the FDA, patients treated with the catheters could face a number of significant risks.

Abbott’s FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system

Abbott shares safety concerns with millions of CGM sensors—7 deaths reported

Approximately 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors need to be replaced due to a risk of incorrect glucose readings. Abbott has received reports of 736 severe adverse events and seven deaths that may be related to this issue.

Cardiology groups share new recommendations for performing safe, effective cardiac ablations in ASCs

The timing of this new guidance from the Heart Rhythm Society and American College of Cardiology could not have been better—the document went live just as CMS finalized its decision to cover cardiac ablation procedures performed in ASCs.

Gregg W. Stone, MD, Director of Academic Affairs for the Mount Sinai Health System and Professor of Medicine (Cardiology) and Professor of Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai, discusses the ATHENS-HF Trial, a first-in-man study of a chronically-adjustbable, bi-atrial pressure sensing inter-atrial shunt from Adona Medical.

Adjustable interatrial shunt for heart failure shows promise in first-in-human trial

Gregg Stone, MD, spoke to Cardiovascular Business about early data from the ATHENS-HF trial. Ten heart failure patients were treated with the adjustable device, and each implant was a success.

Argon Medical Devices Option Elite IVC filter

IVC filter recalled due to injury risk

Customers are urged to stop using these devices right away.

FDA clears TAVR guidewire built with BASILICA in mind

The Telltale system was designed to assist cardiologists when BASILICA is required prior to TAVR.

CMS to cover cardiac ablations performed in ASCs—cardiology group calls it a ‘tremendous victory’

Electrophysiologists can now perform cardiac ablation outside of a hospital setting. Groups such as the American College of Cardiology and Heart Rhythm Society have been pushing for this change for quite some time, pointing to the potential to cut costs and boost patient satisfaction.