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Week in Review: FDA approves TAVR for asymptomatic patients | Heart pump accessories recalled | PFA linked to heart damage risk

News You Need to Know Today
Week in Review: FDA approves TAVR for asymptomatic patients | Heart pump accessories recalled | PFA linked to heart damage risk
Saturday, May 3, 2025
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This Week’s News

A victory for early treatment: FDA approves first TAVR valves for asymptomatic severe aortic stenosis

The FDA has approved the balloon-expandable Sapien 3 TAVR platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis. This is the first time the agency has approved any TAVR technology to be used in asymptomatic patients. 

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Sapien 3 Ultra Resilia TAVR valves
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A victory for early treatment: FDA approves first TAVR valves for asymptomatic severe aortic stenosis

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Sapien 3 Ultra Resilia TAVR valves
The FDA has approved the balloon-expandable Sapien 3 TAVR platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis. This is the first time the agency has approved any TAVR technology to be used in asymptomatic patients. 
READ MORE >

FDA announces new recall of Abbott heart pump accessories over significant safety risks

The mobile power units of certain HeartMate 3 and HeartMate II LVADs have been experiencing “sudden, unexpected performance issues” such as turning on, off or even restarting with no warning. These issues can potentially be fatal, according to an alert shared by the FDA.

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Product Recall
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FDA announces new recall of Abbott heart pump accessories over significant safety risks

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Product Recall
The mobile power units of certain HeartMate 3 and HeartMate II LVADs have been experiencing “sudden, unexpected performance issues” such as turning on, off or even restarting with no warning. These issues can potentially be fatal, according to an alert shared by the FDA.
READ MORE >

Champagne could be good for the heart—and other lessons from a new risk analysis

Researchers explored the potential impact of more than 100 risk factors on a person's risk of sudden cardiac arrest. Some of their findings were what you may expect, but others were much more surprising.

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drink champagne alcohol
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Champagne could be good for the heart—and other lessons from a new risk analysis

Share on Twitter Share on Facebook Share on Linkedin
drink champagne alcohol
Researchers explored the potential impact of more than 100 risk factors on a person's risk of sudden cardiac arrest. Some of their findings were what you may expect, but others were much more surprising.
READ MORE >

PFA associated with elevated risk of heart damage, real-world data show

Patient outcomes do not appear to be negatively impacted by these risks, researchers noted. The new data were presented at Heart Rhythm 2025 and published in JACC: Clinical Electrophysiology.

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PFA associated with elevated risk of heart damage, real-world data show

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Patient outcomes do not appear to be negatively impacted by these risks, researchers noted. The new data were presented at Heart Rhythm 2025 and published in JACC: Clinical Electrophysiology.
READ MORE >

PFA takes center stage at Heart Rhythm 2025 as medtech companies share new data

Pulsed field ablation was one of the biggest topics at Heart Rhythm 2025, the annual meeting of the Heart Rhythm Society. Medtronic, Johnson & Johnson MedTech, Boston Scientific, Abbott, Kardium and Field Medical all shared new data at the conference highlighting the safety and effectiveness of their advanced PFA technologies. 

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Heart Rhythm 2025 Heart Rhythm Society President Kenneth A. Ellenbogen, MD
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PFA takes center stage at Heart Rhythm 2025 as medtech companies share new data

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Heart Rhythm 2025 Heart Rhythm Society President Kenneth A. Ellenbogen, MD
Pulsed field ablation was one of the biggest topics at Heart Rhythm 2025, the annual meeting of the Heart Rhythm Society. Medtronic, Johnson & Johnson MedTech, Boston Scientific, Abbott, Kardium and Field Medical all shared new data at the conference highlighting the safety and effectiveness of their advanced PFA technologies. 
READ MORE >

Society of Thoracic Surgeons shares new risk calculator for complex aortic procedures

The new resource was built to help care teams plan for ascending aorta and aortic root surgeries.

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Society of Thoracic Surgeons shares new risk calculator for aortic surgeries
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Society of Thoracic Surgeons shares new risk calculator for complex aortic procedures

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Society of Thoracic Surgeons shares new risk calculator for aortic surgeries
The new resource was built to help care teams plan for ascending aorta and aortic root surgeries.
READ MORE >

Exploring the evolution of AI in cardiology

Partho Sengupta, MD, shared his perspective on the current state of artificial intelligence in cardiology. The technology continues to evolve, he said, though it does still face certain limitations.

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Partho Sengupta, MD, DM, FACC, FASE, Henry Rutgers Professor of Cardiology and Chief of Cardiovascular Medicine, at Robert Wood Johnson Medical School, and Chief of the Cardiovascular Service Line at Robert Wood Johnson University Hospital, offers an overview of the current state of artificial intelligence (AI) in cardiology. He offers insights from what he has seen from some of the more than 160 FDA-cleared algorithms specific to cardiovascular medicine and what is in development.
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Exploring the evolution of AI in cardiology

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Partho Sengupta, MD, DM, FACC, FASE, Henry Rutgers Professor of Cardiology and Chief of Cardiovascular Medicine, at Robert Wood Johnson Medical School, and Chief of the Cardiovascular Service Line at Robert Wood Johnson University Hospital, offers an overview of the current state of artificial intelligence (AI) in cardiology. He offers insights from what he has seen from some of the more than 160 FDA-cleared algorithms specific to cardiovascular medicine and what is in development.
Partho Sengupta, MD, shared his perspective on the current state of artificial intelligence in cardiology. The technology continues to evolve, he said, though it does still face certain limitations.
READ MORE >

Medtronic receives FDA approval for smallest defibrillation lead of its kind

Medtronic emphasized that this device should be especially valuable when treating younger patients or those with a small anatomy.

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OmniaSecure defibrillation lead for placement within a patient’s right ventricle
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Medtronic receives FDA approval for smallest defibrillation lead of its kind

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OmniaSecure defibrillation lead for placement within a patient’s right ventricle
Medtronic emphasized that this device should be especially valuable when treating younger patients or those with a small anatomy.
READ MORE >

AI helps cardiologists terminate AFib for good with ablation

Advanced AI can provide real-time feedback to cardiologists, helping them deliver high-quality care. 

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AI healthcare doctor surgery procedure artificial intelligence
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AI helps cardiologists terminate AFib for good with ablation

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AI healthcare doctor surgery procedure artificial intelligence
Advanced AI can provide real-time feedback to cardiologists, helping them deliver high-quality care. 
READ MORE >

FDA approves new AI-enabled wearable cardioverter defibrillator

The newly approved device can be worn for up to a week at a time, with no daily maintenance required, and includes advanced AI algorithms that minimize the risk of false alarms or inappropriate shocks.

READ MORE >
Jewel Patch Wearable Cardioverter Defibrillator from Element Science
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FDA approves new AI-enabled wearable cardioverter defibrillator

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Jewel Patch Wearable Cardioverter Defibrillator from Element Science
The newly approved device can be worn for up to a week at a time, with no daily maintenance required, and includes advanced AI algorithms that minimize the risk of false alarms or inappropriate shocks.
READ MORE >

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