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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The Vektor Medical vMap system takes standard 12-lead ECGs and converts them into detailed electro anatomical maps for us in catheter ablation procedures.

AI-powered cardiac mapping system gains an important approval

The vMap System from San Diego-based Vektor Medical turns 12-lead ECGs into 3D maps of the heart. It has already been cleared by the FDA.

The next generation Watchman device is designed to better seal off complex LAA anatomy to prevent strokes in atrial fibrillation patients. It uses an optimized architecture to fill gaps and adapt to the unique characteristics of each patient's appendage, which come in a wide variety of shapes and sizes.

Next-generation Watchman enters trial in 2026 as LAAO volume grows

The next-generation Watchman device is designed to better seal off complex LAA anatomy in a variety of LAA shapes and sizes.

Sentiar CommandEP mixed reality system virtual screens augmented reality

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.

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