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News You Need to Know Today
FDA chooses not to approve nasal spray for heart rhythm issues | Quality & ACO participation | Progress for Abbott's PFA tech
Wednesday, April 23, 2025
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Editor's Choice: Heart Rhythm

FDA chooses not to approve new nasal spray for heart rhythm issues

Etripamil's journey toward FDA approval hit a roadblock. The agency requested additional information on the drug, including a new facility inspection, in a response letter sent to Milestone Pharmaceuticals. 

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FDA chooses not to approve new nasal spray for heart rhythm issues

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nasal_spray.jpg
Etripamil's journey toward FDA approval hit a roadblock. The agency requested additional information on the drug, including a new facility inspection, in a response letter sent to Milestone Pharmaceuticals. 
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Quality of care for heart patients does not improve in first year of ACO participation

Researchers tracked patient outcomes through the use of 15 performance measures related to hypertension, coronary artery disease, heart failure and atrial fibrillation.

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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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Quality of care for heart patients does not improve in first year of ACO participation

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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]
Researchers tracked patient outcomes through the use of 15 performance measures related to hypertension, coronary artery disease, heart failure and atrial fibrillation.
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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 >

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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FDA clears new device for enabling access to the heart’s surface without an exposed needle

CardioVia's ViaOne technology includes a blunt-tip needle that remains concealed to help interventional cardiologists and electrophysiologists treat cardiac arrhythmias with a reduced risk of perforation or any other complications. 

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FDA clears new device for enabling access to the heart’s surface without an exposed needle

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surgery.jpg
CardioVia's ViaOne technology includes a blunt-tip needle that remains concealed to help interventional cardiologists and electrophysiologists treat cardiac arrhythmias with a reduced risk of perforation or any other complications. 
READ MORE >

Abbott’s Amulet LAAO device linked to long-term safety, effectiveness

Researchers explored five-year data from more than 1,800 patients with nonvalvular AFib who underwent LAAO with Abbott's Amulet or Boston Scientific's Watchman 2.5. 

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Amplatzer Amulet Left Atrial Appendage Occluder (LAAO) from Abbott
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Abbott’s Amulet LAAO device linked to long-term safety, effectiveness

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Amplatzer Amulet Left Atrial Appendage Occluder (LAAO) from Abbott
Researchers explored five-year data from more than 1,800 patients with nonvalvular AFib who underwent LAAO with Abbott's Amulet or Boston Scientific's Watchman 2.5. 
READ MORE >

Heart Rhythm Society legislative advocacy group raising funds for electrophysiology

This week, Heart Rhythm Advocates announced its establishment and called on cardiologists and EPs to support its efforts with membership and joining committees to guide efforts.

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Heart Rhythm Advocates (HRA), the political advocacy wing of the Heart Rhythm Society (HRS).
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Heart Rhythm Society legislative advocacy group raising funds for electrophysiology

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Heart Rhythm Advocates (HRA), the political advocacy wing of the Heart Rhythm Society (HRS).
This week, Heart Rhythm Advocates announced its establishment and called on cardiologists and EPs to support its efforts with membership and joining committees to guide efforts.
READ MORE >

Abbott gains CE mark approval for Volt PFA system

The approval, which Abbott said arrived earlier than expected, came after regulators reviewed data from a 2024 clinical trial.

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The Abbott Volt Pulsed Field Ablation catheter was cleared by the FDA in December 2025 and earlier had gained European CE mark.
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Abbott gains CE mark approval for Volt PFA system

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The Abbott Volt Pulsed Field Ablation catheter was cleared by the FDA in December 2025 and earlier had gained European CE mark.
The approval, which Abbott said arrived earlier than expected, came after regulators reviewed data from a 2024 clinical trial.
READ MORE >

In Case You Missed It

Most Americans use devices to monitor their heart—just 1 in 4 share the data with doctors

Just a small fraction of the people tracking their own heart health are actually doing anything with the data, according to a new survey commissioned by The Ohio State University Wexner Medical Center.

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A majority of Americans use a device to monitor their heart health, according to a new survey commissioned by The Ohio State University Wexner Medical Center. However, just 25% of those users take that extra step and share their data with a cardiologist or primary care provider.
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Most Americans use devices to monitor their heart—just 1 in 4 share the data with doctors

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A majority of Americans use a device to monitor their heart health, according to a new survey commissioned by The Ohio State University Wexner Medical Center. However, just 25% of those users take that extra step and share their data with a cardiologist or primary care provider.
Just a small fraction of the people tracking their own heart health are actually doing anything with the data, according to a new survey commissioned by The Ohio State University Wexner Medical Center.
READ MORE >

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