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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AI could help cardiologists predict bleeding, stroke risks in AFib patients on DOACs

Researchers developed several new AI models that could guide the management of patients with non-valvular atrial fibrillation. There is still some work to do in terms of accuracy, but they already appear to outperform the traditional risk scores being used today.

pediatric pacemaker

‘A new alternative’: Tiny pacemakers for infants show early promise

A team of pediatric specialists worked closely with representative from Medtronic to develop the new pacemakers. Overall, the tiny devices—approximately one-quarter the size of a traditional pacemaker—were found to be both safe and effective. They are still under development.

The late-breaking U.S. multicenter admIRE clinical trial at the Heart Rhythm Society 2024 meeting, showed positive data on the long-term safety and effectiveness of the the Biosense Webster Varipulse pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation. #HRS #HRS2024 #PFA

FDA announces catheter recall for Johnson & Johnson PFA system due to stroke risk

The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained.

Kestra Medical Technologies

Wearable heart device company to go public, raise up to $155M

Kestra Medical Technologies, known for its wearable heart monitors and defibrillators, intends to sell 10 million common shares priced somewhere between $14 and $16 per share. 

FDA announces Class I recall of Boston Scientific pacemakers—replacement may be necessary

These safety issues have been linked to more than 800 injuries and two deaths. It is possible, the FDA warned, that some patients may require a device to be removed and replaced. 

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Cardiologist questions FDA’s approval process for high-risk medical devices

The technology used to diagnose, treat and manage cardiovascular disease is always evolving, keeping FDA officials quite busy. But have the agency's standards been slipping in recent years? A cardiologist with Cedars-Sinai Medical Center explored that very question.

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 resumes PFA rollout after stopping to review safety concerns

Johnson & Johnson MedTech has resumed the U.S. rollout of its Varipulse PFA system, sharing new warnings to help physicians. 

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LAAO or DOAC? Mayo Clinic AI helps guide treatment of AFib patients

It can be challenging to know which AFib patients are the best candidates for LAAO. A new algorithm out of Mayo Clinic aims to address that problem.