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News You Need to Know Today
FDA approves leadless CRT device, AI imaging software | Drug helps surgeons avoid a 'bloody mess' | IVC implant shows promise
Wednesday, April 16, 2025
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Today's News and Trends

FDA approves leadless CRT device for heart failure

The WiSE CRT system is approximately the size of a single cooked grain of rice. It works with a patient’s existing implant to provide biventricular pacing. 

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The tiny WiSE CRT system from EBR Systems enables leadless pacing. The WiSE CRT system is approximately the size of a single cooked grain of rice. It works with a patient’s existing implant to provide biventricular pacing.
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FDA approves leadless CRT device for heart failure

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The tiny WiSE CRT system from EBR Systems enables leadless pacing. The WiSE CRT system is approximately the size of a single cooked grain of rice. It works with a patient’s existing implant to provide biventricular pacing.
The WiSE CRT system is approximately the size of a single cooked grain of rice. It works with a patient’s existing implant to provide biventricular pacing. 
READ MORE >

New drug reverses antiplatelet effects of ticagrelor, helping surgeons avoid a 'bloody mess'

Deepak Bhatt, MD, believes bentracimab could be a game-changer if it gains approval. "I think it's the sort of drug that every emergency room and ICU would have to stock," he said. "A cardiac care unit would have to stock a couple of doses, as would every cath lab."

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Video of Deepak Bhatt explaining the benefits of bentracimab in the late-breaking Phase 3 REVERSE-IT trial.
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New drug reverses antiplatelet effects of ticagrelor, helping surgeons avoid a 'bloody mess'

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Video of Deepak Bhatt explaining the benefits of bentracimab in the late-breaking Phase 3 REVERSE-IT trial.
Deepak Bhatt, MD, believes bentracimab could be a game-changer if it gains approval. "I think it's the sort of drug that every emergency room and ICU would have to stock," he said. "A cardiac care unit would have to stock a couple of doses, as would every cath lab."
READ MORE >

FDA clears AI-powered echocardiography software

HeartFocus guides users through the entire process, making it so that even novices can deliver high-quality echocardiograms every time.

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HeartFocus DESKi
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FDA clears AI-powered echocardiography software

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HeartFocus DESKi
HeartFocus guides users through the entire process, making it so that even novices can deliver high-quality echocardiograms every time.
READ MORE >

Implantable IVC sensor shows early potential to guide heart failure management

The goal is to measure changes in a patient’s IVC area and collapsibility, which can help anticipate when heart failure events might occur. This first-in-human study included data from the first 50 patients to receive the device. 

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The FIRE1 Norm inferior vena cava (IVC) heart failure sensor. It is implant in the inferior vena cava (IVC) to track changes in intravascular fluid volume is both safe and feasible, according to new findings published in JACC: Heart Failure.
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Implantable IVC sensor shows early potential to guide heart failure management

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The FIRE1 Norm inferior vena cava (IVC) heart failure sensor. It is implant in the inferior vena cava (IVC) to track changes in intravascular fluid volume is both safe and feasible, according to new findings published in JACC: Heart Failure.
The goal is to measure changes in a patient’s IVC area and collapsibility, which can help anticipate when heart failure events might occur. This first-in-human study included data from the first 50 patients to receive the device. 
READ MORE >

Featured Articles

Why surgery, not TAVR, remains the best treatment for some AS patients

TAVR is being used in more patients to treat severe aortic stenosis. However, according to a new commentary piece, SAVR is still the smartest treatment option for certain populations, including younger patients with bicuspid aortic valves.

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A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]
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Why surgery, not TAVR, remains the best treatment for some AS patients

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A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]
TAVR is being used in more patients to treat severe aortic stenosis. However, according to a new commentary piece, SAVR is still the smartest treatment option for certain populations, including younger patients with bicuspid aortic valves.
READ MORE >

Edwards Lifesciences announces key approval for new mitral valve replacement system

The Sapien M3 device was designed to treat symptomatic mitral regurgitation in patients who are not suitable candidates for surgery or transcatheter edge-to-edge repair.

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The Sapien M3 system for transcatheter mitral valve replacement. Image courtesy of Edwards Lifesciences.
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Edwards Lifesciences announces key approval for new mitral valve replacement system

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The Sapien M3 system for transcatheter mitral valve replacement. Image courtesy of Edwards Lifesciences.
The Sapien M3 device was designed to treat symptomatic mitral regurgitation in patients who are not suitable candidates for surgery or transcatheter edge-to-edge repair.
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Reimbursements, non-compete clauses and more: SCAI focused on key policies in interventional cardiology

SCAI President James B. Hermiller, Jr., MD, detailed the group's key policy concerns in 2025 and beyond in a new video interview. 

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SCAI President James B. Hermiller, Jr., MD, director of the transcatheter structural heart program at Ascension St. Vincent Heart Center, Indianapolis, outlined the organization’s key policy priorities for the year. Among them: physician payment reform, peer review overhaul, medical education debt relief, the elimination of non-compete clauses, and physician mental health protections.
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Reimbursements, non-compete clauses and more: SCAI focused on key policies in interventional cardiology

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SCAI President James B. Hermiller, Jr., MD, director of the transcatheter structural heart program at Ascension St. Vincent Heart Center, Indianapolis, outlined the organization’s key policy priorities for the year. Among them: physician payment reform, peer review overhaul, medical education debt relief, the elimination of non-compete clauses, and physician mental health protections.
SCAI President James B. Hermiller, Jr., MD, detailed the group's key policy concerns in 2025 and beyond in a new video interview. 
READ MORE >

In Case You Missed It

FDA announces new recall of Medtronic surgical devices over safety concerns

The agency warned that any unused devices should be removed from the market and returned to the manufacturer.

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Recall | Product recall
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FDA announces new recall of Medtronic surgical devices over safety concerns

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Recall | Product recall
The agency warned that any unused devices should be removed from the market and returned to the manufacturer.
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Cardiologists make case against routine interventions for asymptomatic severe AS

Aortic valve replacement is likely inevitable for patients with asymptomatic severe aortic stenosis. Immediately performing TAVR or SAVR, however, may not always be the answer.

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Heart failure hospitalizations among young adults are getting more common and more expensive
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Cardiologists make case against routine interventions for asymptomatic severe AS

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Heart failure hospitalizations among young adults are getting more common and more expensive
Aortic valve replacement is likely inevitable for patients with asymptomatic severe aortic stenosis. Immediately performing TAVR or SAVR, however, may not always be the answer.
READ MORE >

Plant-based diets may help patients with diabetes, heart disease live longer

Researchers focused on data from nearly 78,000 adults with cardiometabolic disorders, sharing their findings at ACC.25 in Chicago.

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diet nuts legumes vegetables vegan vegetarian plant-based
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Plant-based diets may help patients with diabetes, heart disease live longer

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diet nuts legumes vegetables vegan vegetarian plant-based
Researchers focused on data from nearly 78,000 adults with cardiometabolic disorders, sharing their findings at ACC.25 in Chicago.
READ MORE >

In Other News

Doctor gets prison time, $20M fine for fraudulent telehealth prescriptions

John R. Manning, MD, pleaded guilty to conspiracy to commit healthcare fraud for issuing unnecessary prescriptions billed to Medicare and receiving more than $812,000 in kickbacks.

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Department of Justice DOJ
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Doctor gets prison time, $20M fine for fraudulent telehealth prescriptions

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Department of Justice DOJ
John R. Manning, MD, pleaded guilty to conspiracy to commit healthcare fraud for issuing unnecessary prescriptions billed to Medicare and receiving more than $812,000 in kickbacks.
READ MORE >

CT radiation exposure could account for 5% of future cancer diagnoses

According to new projections, the nearly 100 million CT scans conducted in the U.S. during 2023 will result in approximately 103,000 future cancer diagnoses annually due to radiation exposure alone.  

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CT radiation exposure could account for 5% of future cancer diagnoses

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According to new projections, the nearly 100 million CT scans conducted in the U.S. during 2023 will result in approximately 103,000 future cancer diagnoses annually due to radiation exposure alone.  
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