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News You Need to Know Today
FDA commissioner's fiery speech | AI outperforms docs | CCTA vs. ICA | More big stories from the last week!
Saturday, September 24, 2022
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This Week’s News

FDA Commissioner Robert Califf delivers fiery speech on innovation, healthcare disparities and misinformation at TCT 2022

“The United States is essentially inventing the technology and then the rest of the world is figuring out how to use it better,” he said.

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TCT 2022 Robert Califf FDA Commissioner. Robert Califf, MD, the 25th commissioner of the U.S. Food and Drug Administration (FDA), delivered the keynote address in front of a packed room of cardiologists, surgeons and medical device manufacturers. A cardiologist himself—and an adjunct professor of cardiology at the Duke University School of Medicine. He spoke on innovation in cardiology and the need to stop misinformation..
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FDA Commissioner Robert Califf delivers fiery speech on innovation, healthcare disparities and misinformation at TCT 2022

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TCT 2022 Robert Califf FDA Commissioner. Robert Califf, MD, the 25th commissioner of the U.S. Food and Drug Administration (FDA), delivered the keynote address in front of a packed room of cardiologists, surgeons and medical device manufacturers. A cardiologist himself—and an adjunct professor of cardiology at the Duke University School of Medicine. He spoke on innovation in cardiology and the need to stop misinformation..
“The United States is essentially inventing the technology and then the rest of the world is figuring out how to use it better,” he said.
READ MORE >

TAVR embolic protection devices fail to reduce stroke risk, but some cardiologists—and a leading vendor—remain encouraged

The PROTECTED TAVR results presented at TCT 2022 resulted in a mix of reactions. For some cardiologists, the slight reduction in the risk of a disabling stroke after TAVR is a positive result. For others, it was simply not enough. 

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The Boston Scientific Sentinel embolic protection system was tested in the PROTECTED TAVR to see if it couple prevent or reduce stroke and disabling stroke numbers during TAVR. #TCT22 #TCT2022.
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TAVR embolic protection devices fail to reduce stroke risk, but some cardiologists—and a leading vendor—remain encouraged

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The Boston Scientific Sentinel embolic protection system was tested in the PROTECTED TAVR to see if it couple prevent or reduce stroke and disabling stroke numbers during TAVR. #TCT22 #TCT2022.
The PROTECTED TAVR results presented at TCT 2022 resulted in a mix of reactions. For some cardiologists, the slight reduction in the risk of a disabling stroke after TAVR is a positive result. For others, it was simply not enough. 
READ MORE >

Artificial intelligence can objectively determine cardiac calcium scores faster than doctors

A new study shows artificial intelligence (AI) algorithms can more rapidly and objectively determine calcium scores in CT and PET/CT images than physicians.

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A study published this week in the Journal of the American College of Cardiology (JACC): Cardiovascular Imaging shows artificial intelligence (AI) algorithms can more rapidly and objectively determine calcium scores in computed tomographic (CT) and positron emission tomographic (PET) images than physicians.[1] The AI also performed well when the images were obtained from very-low-radiation CT attenuation scans. https://doi.org/10.1016/j.jcmg.2022.06.006
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Artificial intelligence can objectively determine cardiac calcium scores faster than doctors

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A study published this week in the Journal of the American College of Cardiology (JACC): Cardiovascular Imaging shows artificial intelligence (AI) algorithms can more rapidly and objectively determine calcium scores in computed tomographic (CT) and positron emission tomographic (PET) images than physicians.[1] The AI also performed well when the images were obtained from very-low-radiation CT attenuation scans. https://doi.org/10.1016/j.jcmg.2022.06.006
A new study shows artificial intelligence (AI) algorithms can more rapidly and objectively determine calcium scores in CT and PET/CT images than physicians.
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FDA clears Edwards Pascal device for transcatheter mitral valve repair

This is the second FDA-cleared transcatheter repair device for the mitral valve. Data from pivotal trial comparing Pascal vs. MitraClip will be presented at TCT 2022.

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he U.S. Food and Drug Administration (FDA) granted market clearance ion September 2022 for the Edwards Lifesciences Corp. Pascal Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER). It is indicated for the treatment of patients with degenerative mitral regurgitation (DMR).
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FDA clears Edwards Pascal device for transcatheter mitral valve repair

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he U.S. Food and Drug Administration (FDA) granted market clearance ion September 2022 for the Edwards Lifesciences Corp. Pascal Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER). It is indicated for the treatment of patients with degenerative mitral regurgitation (DMR).
This is the second FDA-cleared transcatheter repair device for the mitral valve. Data from pivotal trial comparing Pascal vs. MitraClip will be presented at TCT 2022.
READ MORE >

Cardiac CT comparable to invasive angiography when assessing stable chest pain, new meta-analysis confirms

Researchers examined data from nearly 5,400 patients, tracking such outcomes as myocardial infarction, stroke and all-cause mortality. 

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A CTA scan being performed at Beaumont Hospital in Michigan by cardiac CT expert Kavitha M Chinnaiyan, MD. CCTA has largely been used at academic medical centers for the past decade, but it is now expanding in 2022 to community hospitals and clinics thanks to a Class 1A recommendation in the 2021 chest pain guidelines. #CCTA #CTA #Beaumont
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Cardiac CT comparable to invasive angiography when assessing stable chest pain, new meta-analysis confirms

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A CTA scan being performed at Beaumont Hospital in Michigan by cardiac CT expert Kavitha M Chinnaiyan, MD. CCTA has largely been used at academic medical centers for the past decade, but it is now expanding in 2022 to community hospitals and clinics thanks to a Class 1A recommendation in the 2021 chest pain guidelines. #CCTA #CTA #Beaumont
Researchers examined data from nearly 5,400 patients, tracking such outcomes as myocardial infarction, stroke and all-cause mortality. 
READ MORE >

Medtronic launches Evolut FX TAVR system for severe aortic stenosis

This is the fourth device in Medtronic's Evolut TAVR platform. The self-expanding valve gained FDA approval in 2021 for the treatment of high- and low-risk patients presenting with symptomatic severe aortic stenosis.

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Medtronic launches Evolut FX TAVR system aortic stenosis.
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Medtronic launches Evolut FX TAVR system for severe aortic stenosis

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Medtronic launches Evolut FX TAVR system aortic stenosis.
This is the fourth device in Medtronic's Evolut TAVR platform. The self-expanding valve gained FDA approval in 2021 for the treatment of high- and low-risk patients presenting with symptomatic severe aortic stenosis.
READ MORE >

Renal denervation lowered blood pressure in two late-breaking TCT trials 

Results from the Medtronic SYMPLICITY HTN-3 trial long-term results and the pivotal RADIANCE II trial for the Recor ultrasound renal denervation system lowered blood pressure effectively in drug-resistant patients.

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Positive data was presented on the first-generation Symplicity (left) long-term outcomes and from the Recor ultrasound renal denervation system pivotal trial at TCT 2022. #TCT #TCT2022
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Renal denervation lowered blood pressure in two late-breaking TCT trials 

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Positive data was presented on the first-generation Symplicity (left) long-term outcomes and from the Recor ultrasound renal denervation system pivotal trial at TCT 2022. #TCT #TCT2022
Results from the Medtronic SYMPLICITY HTN-3 trial long-term results and the pivotal RADIANCE II trial for the Recor ultrasound renal denervation system lowered blood pressure effectively in drug-resistant patients.
READ MORE >

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