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News You Need to Know Today
FDA clears interventional device | Safety issues leads to recall | TAVR valve used for first time | Shockwave tests new IVL tech
Tuesday, April 15, 2025
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Editor's Choice: Interventional Cardiology

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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surgery.jpg
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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 >

Safety update: FDA announces Class I recall due to atherectomy devices breaking during use

The FDA shared a warning about these safety issues in February, but said it was still reviewing the evidence. The agency is now saying the devices “may cause serious injury or death” if used without following the updated instructions for use.

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Bard Peripheral Vascular Rotarex Atherectomy System recall
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Safety update: FDA announces Class I recall due to atherectomy devices breaking during use

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Bard Peripheral Vascular Rotarex Atherectomy System recall
The FDA shared a warning about these safety issues in February, but said it was still reviewing the evidence. The agency is now saying the devices “may cause serious injury or death” if used without following the updated instructions for use.
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Cardiologists perform world’s first TAVR procedures with new fully retrievable valve

Researchers detailed their experience performing the very first TAVR procedures with the Venus-PowerX TAVR valve from Venus MedTech. The valve includes a wire-controlled mechanism that makes it possible to recapture after full deployment. 

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Venus-PowerX TAVR valve developed by Venus MedTech
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Cardiologists perform world’s first TAVR procedures with new fully retrievable valve

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Venus-PowerX TAVR valve developed by Venus MedTech
Researchers detailed their experience performing the very first TAVR procedures with the Venus-PowerX TAVR valve from Venus MedTech. The valve includes a wire-controlled mechanism that makes it possible to recapture after full deployment. 
READ MORE >

Shockwave Medical testing new-look IVL technology on challenging coronary lesions

Care teams throughout the U.S. and U.K. are now exploring the safety and effectiveness of using Shockwave Medical's new Javelin IVL catheters to treat challenging, difficult-to-cross coronary lesions. 

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Shockwave Medical IVL
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Shockwave Medical testing new-look IVL technology on challenging coronary lesions

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Shockwave Medical IVL
Care teams throughout the U.S. and U.K. are now exploring the safety and effectiveness of using Shockwave Medical's new Javelin IVL catheters to treat challenging, difficult-to-cross coronary lesions. 
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Key takeaways from ACC.25: Advances in cardiovascular science

Former American College of Cardiology president Hadley Wilson, MD, executive vice chair of Atrium Health Sanger Heart and Vascular Institute, explains his main takeaway messages from the ACC 2025 late-breaking trials.

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Former American College of Cardiology president Hadley Wilson, MD, executive vice chair of Atrium Health Sanger Heart and Vascular Institute, and a clinical professor of medicine at Wake Forest University School of Medicine, offers what he saw as the main takeaway messages in the ACC 2025 late breaking trials.
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Key takeaways from ACC.25: Advances in cardiovascular science

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Former American College of Cardiology president Hadley Wilson, MD, executive vice chair of Atrium Health Sanger Heart and Vascular Institute, and a clinical professor of medicine at Wake Forest University School of Medicine, offers what he saw as the main takeaway messages in the ACC 2025 late breaking trials.
Former American College of Cardiology president Hadley Wilson, MD, executive vice chair of Atrium Health Sanger Heart and Vascular Institute, explains his main takeaway messages from the ACC 2025 late-breaking trials.
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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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Boston Scientific finalizes Bolt Medical acquisition as FDA clears company’s IVL technology

Boston Scientific hopes to officially launch its new IVL system in the first half of 2026.

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merger acquisition M&A business
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Boston Scientific finalizes Bolt Medical acquisition as FDA clears company’s IVL technology

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merger acquisition M&A business
Boston Scientific hopes to officially launch its new IVL system in the first half of 2026.
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Advances in bioresorbable stents show promise for treating PAD

Bioresorbable stents are back in the spotlight thanks to some significant progress from multiple medtech companies. Eric Secemsky, MD, discussed some of the biggest breakthroughs in this space at CRT 2025.

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Eric Secemsky, MD, MSc, RPVI, FACC, FAHA, FSCAI, FSVM, director of vascular intervention, Beth Israel Deaconess, section head, interventional cardiology and vascular research, Susan F. Smith Center for Outcomes Research, and associate professor of medicine, Harvard Medical School, explained some of the new bioresorbable stent scaffold technology that is being developed for use in PAD below the knee at CRT 2025.
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Advances in bioresorbable stents show promise for treating PAD

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Eric Secemsky, MD, MSc, RPVI, FACC, FAHA, FSCAI, FSVM, director of vascular intervention, Beth Israel Deaconess, section head, interventional cardiology and vascular research, Susan F. Smith Center for Outcomes Research, and associate professor of medicine, Harvard Medical School, explained some of the new bioresorbable stent scaffold technology that is being developed for use in PAD below the knee at CRT 2025.
Bioresorbable stents are back in the spotlight thanks to some significant progress from multiple medtech companies. Eric Secemsky, MD, discussed some of the biggest breakthroughs in this space at CRT 2025.
READ MORE >

Abbott makes IVL move as FDA approves new clinical trial

Abbott has received an investigational device exemption from the FDA for a new clinical trial evaluating the safety and effectiveness of using its coronary IVL technology. The trial is expected to enroll up to 335 U.S. patients.

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progress step forward business announce
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Abbott makes IVL move as FDA approves new clinical trial

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progress step forward business announce
Abbott has received an investigational device exemption from the FDA for a new clinical trial evaluating the safety and effectiveness of using its coronary IVL technology. The trial is expected to enroll up to 335 U.S. patients.
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Choosing left radial access in the cath lab helps cardiologists limit radiation exposure

Using a left radial artery approach in the cath lab exposes interventional cardiologists to significantly less radiation than a hyper-adducted right radial artery approach. The difference is substantial enough for researchers to declare LRA "the primary access site for cardiac catheterization."

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Using a left radial artery (LRA) vs. hyper-adducted right radial artery (HARRA) approach in the cath lab.
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Choosing left radial access in the cath lab helps cardiologists limit radiation exposure

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Using a left radial artery (LRA) vs. hyper-adducted right radial artery (HARRA) approach in the cath lab.
Using a left radial artery approach in the cath lab exposes interventional cardiologists to significantly less radiation than a hyper-adducted right radial artery approach. The difference is substantial enough for researchers to declare LRA "the primary access site for cardiac catheterization."
READ MORE >

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