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Week in Review: FDA approves leadless CRT device for HF | Cardiologist compensation drops | When SAVR is preferred over TAVR

News You Need to Know Today
Week in Review: FDA approves leadless CRT device for HF | Cardiologist compensation drops | When SAVR is preferred over TAVR
Saturday, April 19, 2025
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This Week’s News

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. 
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Cardiologist compensation drops 4%—still higher than most other healthcare specialties

Cardiology still ranks No. 4 overall, trailing just orthopedics, radiology and plastic surgery.

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Healthcare salaries and compensation
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Cardiologist compensation drops 4%—still higher than most other healthcare specialties

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Healthcare salaries and compensation
Cardiology still ranks No. 4 overall, trailing just orthopedics, radiology and plastic surgery.
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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.
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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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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.
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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."
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Death after 1 year more common for real-world low-risk TAVR patients than those treated in clinical trials

Real-world patients were still associated with "excellent" outcomes, but it is important for cardiologists and patients alike to know as much as possible about the odds of survival following treatment. 

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cardiologist viewing heart data
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Death after 1 year more common for real-world low-risk TAVR patients than those treated in clinical trials

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cardiologist viewing heart data
Real-world patients were still associated with "excellent" outcomes, but it is important for cardiologists and patients alike to know as much as possible about the odds of survival following treatment. 
READ MORE >

FDA clears catheter-based 4D visualization platform for complex heart procedures

The new technology from LUMA Vision allows operators to deliver 2D and 4D ultrasound images in real time. The advanced catheter was built with maneuverability and increased visibility in mind.

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LUMA Vision Verafeye Visualization Platform. The Verafeye Visualization Platform allows operators to deliver 2D and 4D ultrasound images in real time. The catheter was built with maneuverability and increased visibility in mind; it can capture images of up to 120 mm from the tip and provide views of the patient’s anatomy from all angles.
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FDA clears catheter-based 4D visualization platform for complex heart procedures

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LUMA Vision Verafeye Visualization Platform. The Verafeye Visualization Platform allows operators to deliver 2D and 4D ultrasound images in real time. The catheter was built with maneuverability and increased visibility in mind; it can capture images of up to 120 mm from the tip and provide views of the patient’s anatomy from all angles.
The new technology from LUMA Vision allows operators to deliver 2D and 4D ultrasound images in real time. The advanced catheter was built with maneuverability and increased visibility in mind.
READ MORE >

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 >

Cardiologist-founded startup announces FDA clearance, first uses of new TAVR pacing system

“The device takes variability out of the procedure by giving the operator full control while automating ramp-up and back-up algorithms," according to a clinician who used the new technology. "The TAVR procedure is simplified, reducing physician and staff workload."

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Solo Pace Incorporated SoloPace Control System
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Cardiologist-founded startup announces FDA clearance, first uses of new TAVR pacing system

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Solo Pace Incorporated SoloPace Control System
“The device takes variability out of the procedure by giving the operator full control while automating ramp-up and back-up algorithms," according to a clinician who used the new technology. "The TAVR procedure is simplified, reducing physician and staff workload."
READ MORE >

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