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Week in Review: FDA approves all-in-one PFA system | TAVR for asymptomatic AS | Cardiologist gets life in prison

News You Need to Know Today
Week in Review: FDA approves all-in-one PFA system | TAVR for asymptomatic AS | Cardiologist gets life in prison
Saturday, November 2, 2024
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This Week’s News

FDA approves Medtronic’s new all-in-one mapping and ablation system for AFib

Medtronic is now the first company to offer two FDA-approved PFA systems for the treatment of persistent AFib. The company’s PulseSelect PFA system gained approval in December 2023. 

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Medtronic's Affera mapping and ablation system with the Sphere-9 catheter
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FDA approves Medtronic’s new all-in-one mapping and ablation system for AFib

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Medtronic's Affera mapping and ablation system with the Sphere-9 catheter
Medtronic is now the first company to offer two FDA-approved PFA systems for the treatment of persistent AFib. The company’s PulseSelect PFA system gained approval in December 2023. 
READ MORE >

Abbott CGM sensors can now be worn during common imaging procedures

Sensors from the FreeStyle Libre 2 and Libre 3 continuous glucose monitoring systems can now be worn during X-rays, CT scans and MRI scans. The news represents a shift in policy from the FDA, one that came after the agency reviewed extensive testing data.

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Abbott’s FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system.
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Abbott CGM sensors can now be worn during common imaging procedures

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Abbott’s FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system.
Sensors from the FreeStyle Libre 2 and Libre 3 continuous glucose monitoring systems can now be worn during X-rays, CT scans and MRI scans. The news represents a shift in policy from the FDA, one that came after the agency reviewed extensive testing data.
READ MORE >

Colchicine falls flat in large heart attack trial, convincing cardiologists to stay away

Treating AMI patients with colchicine is not associated with better cardiovascular outcomes, according to new data presented at TCT. The drug did help with inflammation, but that was the only benefit researchers could identify.

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Cardiologist Sanjit Jolly, MD, MSc, at TCT 2024
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Colchicine falls flat in large heart attack trial, convincing cardiologists to stay away

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Cardiologist Sanjit Jolly, MD, MSc, at TCT 2024
Treating AMI patients with colchicine is not associated with better cardiovascular outcomes, according to new data presented at TCT. The drug did help with inflammation, but that was the only benefit researchers could identify.
READ MORE >

Treating asymptomatic aortic stenosis with TAVR linked to significant benefits

Attendees cheered as lead investigator Philippe Généreux, MD, shared his team's findings at TCT 2024. “A major reset in our approach to severe asymptomatic AS is now warranted,” one veteran cardiologist said about the data. “The concept of watchful waiting is no longer appropriate."

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EARLY TAVR investigator Philippe Généreux, MD, announced his team’s findings in front of a packed audience at TCT 2024.
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Treating asymptomatic aortic stenosis with TAVR linked to significant benefits

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EARLY TAVR investigator Philippe Généreux, MD, announced his team’s findings in front of a packed audience at TCT 2024.
Attendees cheered as lead investigator Philippe Généreux, MD, shared his team's findings at TCT 2024. “A major reset in our approach to severe asymptomatic AS is now warranted,” one veteran cardiologist said about the data. “The concept of watchful waiting is no longer appropriate."
READ MORE >

Cardiologist receives 158 years to life in prison for drugging, sexually assaulting multiple women

“You hurt our society," the judge said as he announced the sentencing in front of a packed courtroom. "It is a darker place because of you.” 

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A gavel and a stethoscope
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Cardiologist receives 158 years to life in prison for drugging, sexually assaulting multiple women

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A gavel and a stethoscope
“You hurt our society," the judge said as he announced the sentencing in front of a packed courtroom. "It is a darker place because of you.” 
READ MORE >

Boston Scientific TAVR valve comes up short in comparison with Medtronic, Edwards devices

The Acurate neo2 TAVR valve has been used to treat severe aortic stenosis in other parts of the world for years. In the United States, however, the device has still not been approved for commercial use.  

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Boston Scientific ACURATE neo2 aortic valve system self-expanding TAVR valve.
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Boston Scientific TAVR valve comes up short in comparison with Medtronic, Edwards devices

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Boston Scientific ACURATE neo2 aortic valve system self-expanding TAVR valve.
The Acurate neo2 TAVR valve has been used to treat severe aortic stenosis in other parts of the world for years. In the United States, however, the device has still not been approved for commercial use.  
READ MORE >

IVL vs. RA for chronic total occlusion PCI: Key data cardiologists should know

Patient outcomes for these two treatments are similar, but choosing IVL may help improve clinical workflows. 

READ MORE >
The Shockwave Medical M5+ new peripheral intravascular lithotripsy (IVL) catheter cuts procedures times in half and was showed for the first time at the American College of Cardiology (ACC) 2022 meeting. It is designed to break up calcium in heavily calcified arteries to avoid the need for vessel trauma caused by high pressure angioplasty.
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IVL vs. RA for chronic total occlusion PCI: Key data cardiologists should know

Share on Twitter Share on Facebook Share on Linkedin
The Shockwave Medical M5+ new peripheral intravascular lithotripsy (IVL) catheter cuts procedures times in half and was showed for the first time at the American College of Cardiology (ACC) 2022 meeting. It is designed to break up calcium in heavily calcified arteries to avoid the need for vessel trauma caused by high pressure angioplasty.
Patient outcomes for these two treatments are similar, but choosing IVL may help improve clinical workflows. 
READ MORE >

Medicare coverage expands again for AI-enabled coronary plaque assessments

Another MAC has agreed to cover the use of these advanced technologies to evaluate patients for signs of coronary artery disease. 

READ MORE >
robot reviewing heart data
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Medicare coverage expands again for AI-enabled coronary plaque assessments

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robot reviewing heart data
Another MAC has agreed to cover the use of these advanced technologies to evaluate patients for signs of coronary artery disease. 
READ MORE >

Impella ECP confirmed to be safe for high-risk PCI—is FDA approval next?

The Impella ECP heart pump, which measures at just 3 mm in length, was linked to positive safety data in a new study presented at TCT 2024.

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Impella ECP heart pump insertion Abiomed Johnson & Johnson MedTech
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Impella ECP confirmed to be safe for high-risk PCI—is FDA approval next?

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Impella ECP heart pump insertion Abiomed Johnson & Johnson MedTech
The Impella ECP heart pump, which measures at just 3 mm in length, was linked to positive safety data in a new study presented at TCT 2024.
READ MORE >

TAVR linked to better outcomes than surgery for women, pooled analysis confirms

New research presented at TCT combined data from the RHEIA and PARTNER 3 trials. “TAVR is a good option, and probably the best one, for an elderly woman," cardiologist Anna Sonia Petronio, MD, explained during the conference. 

READ MORE >
Didier Tchétché, MD, an interventional cardiologist and head of the structural heart disease program at Clinique Pasteur in Toulouse, France, and colleagues combined data from the RHEIA and PARTNER 3 trials into a single comparison of TAVR outcomes in female patients.
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TAVR linked to better outcomes than surgery for women, pooled analysis confirms

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Didier Tchétché, MD, an interventional cardiologist and head of the structural heart disease program at Clinique Pasteur in Toulouse, France, and colleagues combined data from the RHEIA and PARTNER 3 trials into a single comparison of TAVR outcomes in female patients.
New research presented at TCT combined data from the RHEIA and PARTNER 3 trials. “TAVR is a good option, and probably the best one, for an elderly woman," cardiologist Anna Sonia Petronio, MD, explained during the conference. 
READ MORE >

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