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News You Need to Know Today
Device safety issues for Boston Scientific | Early rhythm control boosts outcomes | EP catheters recalled | Drug candidate fails
Tuesday, August 19, 2025
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Editor's Choice: Heart Rhythm

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.

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

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Watchman TruSteer Access System
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.
READ MORE >

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.

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U.S. FDA Sign
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FDA details defibrillation lead issue linked to 386 injuries, 16 deaths

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U.S. FDA Sign
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.
READ MORE >

Early rhythm control boosts AFib outcomes for patients with obesity, diabetes

Researchers expected these conditions to reduce the benefits of early treatment. However, that was not the case.

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doctorwithpatient.jpg
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Early rhythm control boosts AFib outcomes for patients with obesity, diabetes

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doctorwithpatient.jpg
Researchers expected these conditions to reduce the benefits of early treatment. However, that was not the case.
READ MORE >

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.

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Reprocessed Supreme Fixed Electrophysiology Catheter
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FDA announces new recall of reprocessed EP catheters due to risk of contamination

Share on Twitter Share on Facebook Share on Linkedin
Reprocessed Supreme Fixed Electrophysiology Catheter
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.
READ MORE >

New LAAO guidelines: 6 key takeaways for interventional cardiologists and electrophysiologists

SCAI and HRS have collaborated on new guidelines designed to help clinicians make the safest, smartest treatment decisions possible.

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Newsweek ranked the 50 best heart hospitals in the world
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New LAAO guidelines: 6 key takeaways for interventional cardiologists and electrophysiologists

Share on Twitter Share on Facebook Share on Linkedin
Newsweek ranked the 50 best heart hospitals in the world
SCAI and HRS have collaborated on new guidelines designed to help clinicians make the safest, smartest treatment decisions possible.
READ MORE >

FDA clears first robotically guided EP mapping catheter for ablation

Stereotaxis has received FDA clearance for the first mapping catheter of its kind. The company emphasized that this is just the first of many robotically navigated devices it is working to bring to the U.S. market.

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Stereotaxis MAGIC SWEEP electrophysiology catheter
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FDA clears first robotically guided EP mapping catheter for ablation

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Stereotaxis MAGIC SWEEP electrophysiology catheter
Stereotaxis has received FDA clearance for the first mapping catheter of its kind. The company emphasized that this is just the first of many robotically navigated devices it is working to bring to the U.S. market.
READ MORE >

ICD patients may experience fear, anxiety or depression due to their devices

Some patients feel anxiety due to the risk of being shocked. Others have device recalls and/or cybersecurity threats on their mind.

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‘Notably high’ rates of PTSD, depression and anxiety seen in patients with implantable heart devices
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ICD patients may experience fear, anxiety or depression due to their devices

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‘Notably high’ rates of PTSD, depression and anxiety seen in patients with implantable heart devices
Some patients feel anxiety due to the risk of being shocked. Others have device recalls and/or cybersecurity threats on their mind.
READ MORE >

New drug candidate for AFib fails in first-in-human trial—in fact, it made matters worse

Researchers had thought 2-HOBA might reduce the risk of AFib recurrence after catheter ablation procedures. What they found, however, was that treatment with the compound was actually harmful for patients instead of helpful. 

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pharmaceutical drug approval process
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New drug candidate for AFib fails in first-in-human trial—in fact, it made matters worse

Share on Twitter Share on Facebook Share on Linkedin
pharmaceutical drug approval process
Researchers had thought 2-HOBA might reduce the risk of AFib recurrence after catheter ablation procedures. What they found, however, was that treatment with the compound was actually harmful for patients instead of helpful. 
READ MORE >

New gene therapy for rare heart condition gains FDA’s fast track designation

Catecholaminergic polymorphic ventricular tachycardia is a rare, potentially fatal heart rhythm disorder. A new gene therapy candidate from Solid Biosciences is now one step closer to FDA approval. 

READ MORE >
Compensation for U.S. cardiologists is up across the board, according to a recent survey published by MedAxiom, an American College of Cardiology company. The report identified similar trends for cardiovascular surgeons, highlighting the country’s high demand for all heart specialists in 2024 and beyond.
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New gene therapy for rare heart condition gains FDA’s fast track designation

Share on Twitter Share on Facebook Share on Linkedin
Compensation for U.S. cardiologists is up across the board, according to a recent survey published by MedAxiom, an American College of Cardiology company. The report identified similar trends for cardiovascular surgeons, highlighting the country’s high demand for all heart specialists in 2024 and beyond.
Catecholaminergic polymorphic ventricular tachycardia is a rare, potentially fatal heart rhythm disorder. A new gene therapy candidate from Solid Biosciences is now one step closer to FDA approval. 
READ MORE >

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