Electrophysiology

The cardiac subspecialty of electrophysiology (EP) diagnoses and treats arrhythmias. This includes use of pacemakers to treat bradycardia, implantable cardioverter defibrillators (ICD) for tachycardia, heart failure and patients at risk of sudden cardiac arrest, and cardiac ablation treatments to treat heart rhythm disorders.

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.

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.

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.

Biosense Webster, part of Johnson & Johnson MedTech, shared updated data on its Varipulse pulsed field ablation (PFA) system at AF Symposium 2024 in Boston,

Johnson & Johnson’s PFA platform is both safe and effective, real-world data confirm

The Varipulse PFA platform, which has already received FDA and CE mark approval, was linked to an adverse event rate of just 0.6%. 

Edwards Lifesciences gains CE mark approval for Evoque transcatheter tricuspid valve replacement (TTVR) system

Old age, RBBB help predict when TTVR patients may require a permanent pacemaker

Though just a small, single-facility study, these findings help care teams know what to look for when performing transcatheter tricuspid valve replacement.

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Johnson & Johnson MedTech hit with permanent injunction as fallout over antitrust lawsuit continues

Johnson & Johnson MedTech was already ordered to pay $442.2 million in damages for withholding clinical support to healthcare providers. Now the company has been hit with a permanent injunction designed to stop it from being a repeat offender.

Farapulse Boston Scientific Pulsed Field Ablation PFA fda approval

PFA linked to increased risk of phrenic nerve damage

“We believe that any iatrogenic complication should be reported,” the study's authors wrote. “No patient expects to be discharged from hospital with a new diaphragmatic deficit without being informed."

The U.S. Food and Drug Administration (FDA) updated the Breakthrough Device Program designations data this week, which now includes 1,176 Breakthrough Device designations, of which 160 have gained market clearance. Cardiovascular devices lead these with 243 devices, the highest number out of all other clinical categories. This includes 16 new cardiovascular devices cleared in the past year.

Cardiovascular device approvals continue to lead the FDA's Breakthrough Device Program

Cardiology is number one in FDA Breakthrough Device designations at 218, the highest number out of all other clinical categories. This includes 16 new devices cleared in the past year.