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.

Cardiologist makes history with first commercial implant of new pacing lead for LBBAP
The first FDA-approved pacing lead specifically developed for LBBAP is now being implanted throughout the United States.
FDA approves smallest defibrillation lead of its kind for LBBA placement
The OmniaSecure defibrillation lead from Medtronic is already approved for placement in the right ventricle. This latest approval covers the left bundle branch area, opening the door for conduction system pacing and other advanced techniques.
Cardiology now has more than 200 FDA-cleared AI algorithms
Cardiology is No. 2 behind radiology when it comes to FDA-cleared AI algorithms. Neurology, meanwhile, is a distant No. 3.
FDA shares details about reprocessed catheter recall
Back in February, the FDA expanded a recall of several reprocessed EP and ultrasound catheters due to a risk of contamination. The agency is now sharing additional information with the public.
Boston Scientific’s Farapulse PFA system receives expanded approval
The technology first gained CE mark approval for the treatment of paroxysmal AFib in 2021, when PFA was still brand new. Now, thanks to positive results from the ADVANTAGE AF clinical trial, it is approved for persistent AFib as well.

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.

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.

Medtech company raises $32M for foam-based LAAO device

New Hampshire-based Conformal Medical plans on using the funds to enroll more patients into an ongoing clinical trial.

Reprocessed Supreme Fixed Electrophysiology Catheter

FDA announces new recall of reprocessed EP catheters due to risk of contamination

Customers with these devices on hand are asked to return them right away. No serious injuries have been reported at this time, but the presence of residual particulates can lead to such side effects as pulmonary embolism and deep vein thrombosis.

FDA says Watchman access systems may increase risk of air embolism—17 deaths reported

Because of this risk, which has been associated with 120 serious injuries, Boston Scientific is updating the instructions for use of several Watchman access systems.

FDA details defibrillation lead issue linked to 386 injuries, 16 deaths

Boston Scientific manufactured these devices from 2002 to 2021, and approximately 354,000 are still in use. It is recommended that clinicians look for early signs of this issue during scheduled follow-up appointments.

Electrophysiology

Cardiologist makes history with first commercial implant of new pacing lead for LBBAP

FDA approves smallest defibrillation lead of its kind for LBBA placement

Cardiology now has more than 200 FDA-cleared AI algorithms

FDA shares details about reprocessed catheter recall

Boston Scientific’s Farapulse PFA system receives expanded approval