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News You Need to Know Today
Troubled heart devices recalled again | Surgery & interventional therapies for HCM | FDA's new labeling guidance
Friday, August 11, 2023
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Today's News and Trends

FDA announces fourth recall of 2023 for troubled heart devices

This latest recall was brought on by electrical failures and includes more than 4,500 devices. There have been 26 complaints due to the issue but no reported injuries or deaths. 

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Product Recall
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FDA announces fourth recall of 2023 for troubled heart devices

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Product Recall
This latest recall was brought on by electrical failures and includes more than 4,500 devices. There have been 26 complaints due to the issue but no reported injuries or deaths. 
READ MORE >

Surgery, interventional therapies still the best choice for many HCM patients

"You have to look at each patient and understand their goals," one HCM expert said in a new interview. 

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Video of Hari Naidu, MD, director of the Hypertrophic Cardiomyopathy Center of Excellence at Westchester Medical Center, explaining the role of alcohol septal ablation and surgical myectomy in the era of mavacamten. #HCM #ASE
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Surgery, interventional therapies still the best choice for many HCM patients

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Video of Hari Naidu, MD, director of the Hypertrophic Cardiomyopathy Center of Excellence at Westchester Medical Center, explaining the role of alcohol septal ablation and surgical myectomy in the era of mavacamten. #HCM #ASE
"You have to look at each patient and understand their goals," one HCM expert said in a new interview. 
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FDA highlights importance of including heart rhythm risks on drug labels

The agency has shared a new draft guidance focused on the inclusion of information related to QTc interval prolongation. 

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The U.S. Food and Drug Administration (FDA) has issued a new draft guidance designed to help applicants add clinically relevant information about QTc interval prolongation to the labeling of non-antiarrhythmic drugs
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FDA highlights importance of including heart rhythm risks on drug labels

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The U.S. Food and Drug Administration (FDA) has issued a new draft guidance designed to help applicants add clinically relevant information about QTc interval prolongation to the labeling of non-antiarrhythmic drugs
The agency has shared a new draft guidance focused on the inclusion of information related to QTc interval prolongation. 
READ MORE >

Featured Articles

FDA approves Boston Scientific’s new cryoablation system for AFib

The system includes an expandable cryoablation balloon catheter compatible with multiple balloon sizes. 

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Boston Scientific’s POLARx Cryoablation System to treat atrial fibrillation gained FDA approval in August 2023. It is compatible with two balloon sizes, 31 and 28 mm to fit different sized anatomies.
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FDA approves Boston Scientific’s new cryoablation system for AFib

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Boston Scientific’s POLARx Cryoablation System to treat atrial fibrillation gained FDA approval in August 2023. It is compatible with two balloon sizes, 31 and 28 mm to fit different sized anatomies.
The system includes an expandable cryoablation balloon catheter compatible with multiple balloon sizes. 
READ MORE >

How medical imaging helps cardiologists treat hypertrophic cardiomyopathy

Hypertrophic cardiomyopathy expert Sherif F. Nagueh, MD, examined imaging's role in treating this serious condition. 

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HCM expert Sherif F. Nagueh, MD, FACC, FASE, professor of cardiology, Methodist DeBakey Heart and Vascular Center, explains the key points of HCM imaging. #ASE #HCM
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How medical imaging helps cardiologists treat hypertrophic cardiomyopathy

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HCM expert Sherif F. Nagueh, MD, FACC, FASE, professor of cardiology, Methodist DeBakey Heart and Vascular Center, explains the key points of HCM imaging. #ASE #HCM
Hypertrophic cardiomyopathy expert Sherif F. Nagueh, MD, examined imaging's role in treating this serious condition. 
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A surgeon's perspective on treating hypertrophic cardiomyopathy

Nicholas Smedira, MD, a cardiovascular surgeon with Cleveland Clinic, discusses septal myectomy and the need to improve overall HCM care with new standards and evidence-based guidelines.

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Photo of a surgical cardiac septal myectomy to treat hypertrophic cardiomyopathy (HCM). Nicholas Smedira MD discusses septal myectomy in HCM patients and the need for more detailed protocols for HCM care. #HCM #ASE #ASE2023 #myectomy
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A surgeon's perspective on treating hypertrophic cardiomyopathy

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Photo of a surgical cardiac septal myectomy to treat hypertrophic cardiomyopathy (HCM). Nicholas Smedira MD discusses septal myectomy in HCM patients and the need for more detailed protocols for HCM care. #HCM #ASE #ASE2023 #myectomy
Nicholas Smedira, MD, a cardiovascular surgeon with Cleveland Clinic, discusses septal myectomy and the need to improve overall HCM care with new standards and evidence-based guidelines.
READ MORE >

Relaxed fasting instructions prior to TAVR, other heart procedures do not affect outcomes

Fasting before major operations has been common in healthcare for nearly 80 years, but that has started to change since the turn of the century. 

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fasting before tavr or ablation
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Relaxed fasting instructions prior to TAVR, other heart procedures do not affect outcomes

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fasting before tavr or ablation
Fasting before major operations has been common in healthcare for nearly 80 years, but that has started to change since the turn of the century. 
READ MORE >

In Case You Missed It

Abbott pulls Trifecta heart valves off the market due to early deterioration

The FDA sent notice today that Abbott is pulling the Trifecta aortic surgical heart valve off the U.S. market due to the risk of early structural valve deterioration in less than 5 years. 

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Abbott pulled the Trifecta GTaortic surgical valve off market in July 2023 after it was determined it had early structural valve deterioration (SVD) before 5 years.
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Abbott pulls Trifecta heart valves off the market due to early deterioration

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Abbott pulled the Trifecta GTaortic surgical valve off market in July 2023 after it was determined it had early structural valve deterioration (SVD) before 5 years.
The FDA sent notice today that Abbott is pulling the Trifecta aortic surgical heart valve off the U.S. market due to the risk of early structural valve deterioration in less than 5 years. 
READ MORE >

FDA clears new AI to guide point-of-care cardiac ultrasound exams

The FDA approved UltraSight's AI to show ultrasound users how to perform a diagnostic quality cardiac ultrasound exam at the point of care in multiple settings.

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Ultrasight's AI to guide echo cardiac ultrasound POCUS exams at ASE 2023. The thumbnail of the chest shows the user how to the position the transducer and where to move or stop for image acquisition. The bar graph shows the quality of the image.
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FDA clears new AI to guide point-of-care cardiac ultrasound exams

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Ultrasight's AI to guide echo cardiac ultrasound POCUS exams at ASE 2023. The thumbnail of the chest shows the user how to the position the transducer and where to move or stop for image acquisition. The bar graph shows the quality of the image.
The FDA approved UltraSight's AI to show ultrasound users how to perform a diagnostic quality cardiac ultrasound exam at the point of care in multiple settings.
READ MORE >

In Other News

Kim Kardashian promotes whole-body MRI service from Prenuvo, drawing concern from some

The reality star shared her experience Tuesday via Instagram, hoping to inform her 363 million followers about this “lifesaving machine.” 

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Prenuvo's newest location in New York City.
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Kim Kardashian promotes whole-body MRI service from Prenuvo, drawing concern from some

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Prenuvo's newest location in New York City.
The reality star shared her experience Tuesday via Instagram, hoping to inform her 363 million followers about this “lifesaving machine.” 
READ MORE >

Hospital CEO turnover encouragingly low for third straight year: ACHE

U.S. hospital CEOs continue sticking with the job at the highest rate since 2010 and 2011.

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hospital CEO turnover ACHE
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Hospital CEO turnover encouragingly low for third straight year: ACHE

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hospital CEO turnover ACHE
U.S. hospital CEOs continue sticking with the job at the highest rate since 2010 and 2011.
READ MORE >

Industry News

 

Corazon and the Society for Cardiovascular Angiography and Interventions announce partnership

The agreement formally endorses Corazon’s cardiovascular accreditation.   
READ MORE >
 

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