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Patient deaths lead to device recalls | Cardiologists perform first-in-human heart procedures | AFib & TAVR

News You Need to Know Today
Patient deaths lead to device recalls | Cardiologists perform first-in-human heart procedures | AFib & TAVR
Friday, December 27, 2024
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Editor's Choice: Heart Rhythm

FDA announces recall of cryoablation catheters after multiple injuries, including 4 deaths

Boston Scientific is recalling the catheters associated with its POLARx Cryoablation System due to a heightened risk of esophageal injury. The FDA has ruled that this a Class I recall.

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Product Recall
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FDA announces recall of cryoablation catheters after multiple injuries, including 4 deaths

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Product Recall
Boston Scientific is recalling the catheters associated with its POLARx Cryoablation System due to a heightened risk of esophageal injury. The FDA has ruled that this a Class I recall.
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FDA and Boston Scientific issue urgent alert about pacemaker failures following 2 deaths

The U.S. Food and Drug Administration issued the recall notice for more than 200,000 pacemakers because a battery issue could lock the device in safe mode. 

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Boston Scientific recalls more than 200,000 pacemakers after 2 deaths and 697 confirmed malfunctions.
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FDA and Boston Scientific issue urgent alert about pacemaker failures following 2 deaths

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Boston Scientific recalls more than 200,000 pacemakers after 2 deaths and 697 confirmed malfunctions.
The U.S. Food and Drug Administration issued the recall notice for more than 200,000 pacemakers because a battery issue could lock the device in safe mode. 
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Cardiologists perform world’s first leadless LBBAP procedures with Abbott pacemaker

The first-in-human procedures were performed in Prague with the investigational Aveir CSP leadless pacemaker system.

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Left: Petr Neužil, MD, PhD, head of the department of cardiology at Na Homolce Hospital in Prague, Czech Republic / Right: Vivek Y. Reddy, MD, director of cardiac arrhythmia services at Mount Sinai Hospital in New York City
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Cardiologists perform world’s first leadless LBBAP procedures with Abbott pacemaker

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Left: Petr Neužil, MD, PhD, head of the department of cardiology at Na Homolce Hospital in Prague, Czech Republic / Right: Vivek Y. Reddy, MD, director of cardiac arrhythmia services at Mount Sinai Hospital in New York City
The first-in-human procedures were performed in Prague with the investigational Aveir CSP leadless pacemaker system.
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President of medical device company resigns over conduct allegations after 7 months in role

Joseph C. Wright, a longtime Merit Medical employee, resigned after unspecified allegations regarding his conduct were brought to light. He was named the company's new president back in May.

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Joseph C. Wright resigns from Merit Medical
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President of medical device company resigns over conduct allegations after 7 months in role

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Joseph C. Wright resigns from Merit Medical
Joseph C. Wright, a longtime Merit Medical employee, resigned after unspecified allegations regarding his conduct were brought to light. He was named the company's new president back in May.
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FDA approves new short-term treatment for AFib, atrial flutter in critical care settings

Landiolol, sold by AOP Health under the brand name Rapiblyk, is an intravenous treatment designed to start working right away.

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American Heart Association and Joint Commission launch new Comprehensive Heart Attack Center certification.
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FDA approves new short-term treatment for AFib, atrial flutter in critical care settings

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American Heart Association and Joint Commission launch new Comprehensive Heart Attack Center certification.
Landiolol, sold by AOP Health under the brand name Rapiblyk, is an intravenous treatment designed to start working right away.
READ MORE >

Treating AFib patients with TAVR still linked to elevated risks

While the technology and techniques associated with TAVR have advanced over the years, treating patients who present with baseline atrial fibrillation is still associated with certain risks.

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A TAVR procedure being performed at Northwestern Medicine in Chicago.
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Treating AFib patients with TAVR still linked to elevated risks

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A TAVR procedure being performed at Northwestern Medicine in Chicago.
While the technology and techniques associated with TAVR have advanced over the years, treating patients who present with baseline atrial fibrillation is still associated with certain risks.
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‘A significant step forward’: Advocates cheer as heart health bill passes Senate

The HEARTS Act is focused on improving cardiomyopathy education and awareness while getting more AEDs in schools. The ACC, AHA and other medical societies have supported the bipartisan bill, which now heads to the president's desk to be signed into law.

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An automated external defibrillator (AED) system installed in a public location to save patients who go into sudden cardiac arrest (sudden cardiac death).
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‘A significant step forward’: Advocates cheer as heart health bill passes Senate

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An automated external defibrillator (AED) system installed in a public location to save patients who go into sudden cardiac arrest (sudden cardiac death).
The HEARTS Act is focused on improving cardiomyopathy education and awareness while getting more AEDs in schools. The ACC, AHA and other medical societies have supported the bipartisan bill, which now heads to the president's desk to be signed into law.
READ MORE >

Medical device company cuts 70% of staff in push to meet Medtronic obligations

California-based Acutus Medical has said its ongoing agreement to manufacture and distribute left-heart access devices for Medtronic is the company's only source of revenue. 

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Acutus Medical, the California-based healthcare technology company focused on electrophysiology devices, has announced significant downsizing that will cut its workforce by approximately 70%. The goal of the move is to focus exclusively on manufacturing and distributing left-heart access devices as part of a distribution deal with Medtronic that was first signed in 2022.
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Medical device company cuts 70% of staff in push to meet Medtronic obligations

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Acutus Medical, the California-based healthcare technology company focused on electrophysiology devices, has announced significant downsizing that will cut its workforce by approximately 70%. The goal of the move is to focus exclusively on manufacturing and distributing left-heart access devices as part of a distribution deal with Medtronic that was first signed in 2022.
California-based Acutus Medical has said its ongoing agreement to manufacture and distribute left-heart access devices for Medtronic is the company's only source of revenue. 
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