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.

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Virtual screens could make augmented reality more useful during cardiac ablation

It's still early, but a new feature could provide significant value when electrophysiologists use augmented reality during ablation procedures. 

Abbott has recalled its TactiFlex Ablation Catheter, Sensor Enabled, because of reports that the tip can separate.

Abbott warns EP labs the tip can detach from its TactiFlex ablation catheters

Improper removal of the catheter from the packaging can result in tip damage. Most damaged tips were detected prior to being used, but three tips did separate inside patients.
 

All medical device products in Europe need to obtain the Conformité Européenne mark (European Conformity, or CE mark) regulatory approval. This is based on minimal safety requirements and is needed to be sold in the EU.

Cardiologists lead charge for medical device approvals in Europe to be more rigorous

There is a belief among some clinicians that it is too easy for companies to gain CE mark approval for their medical devices. However, a new proposal from the European Society of Cardiology and other groups could help change that. 

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Update: FDA confirms recalls for defibrillation leads after nearly 400 injuries

Safety concerns with certain Boston Scientific leads have resulted in multiple Class I recalls, the FDA has announced. The agency first shared a warning about this issue in August. 

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Boston Scientific to purchase Elutia’s drug-eluting envelope business for $88M

The FDA-cleared EluPro bioenvelope delivers two antibiotics to patients over an extended period of time after they receive an implantable pacemaker or defibrillator to cut infection rates.

Exploring the link between left ventricular diastolic function and AFib

Evaluating LVDF with echocardiography or AI-powered electrocardiography can help identify individuals at an increased risk of developing atrial fibrillation, according to new data presented at the ASE 36th Annual Scientific Sessions.

Newsweek ranked the 50 best heart hospitals in the world

Q&A: Cardiologist explores CMS proposal to cover cardiac ablations performed in ambulatory surgical centers

CMS has proposed a policy shift that would allow cardiac ablation procedures to be performed in ambulatory surgical centers. Arash Aryana, MD, PhD, a veteran cardiac electrophysiologist, explained why he is "extremely encouraged" by this proposal, highlighting several potential benefits. 

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.