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News You Need to Know Today
FDA clears a long-term cardiac monitor for pediatric patients for first time | More big news out of TCT 2022
Wednesday, September 21, 2022
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Today's News and Trends

FDA grants new pediatric indication for Medtronic Linq II implantable cardiac monitor 

The FDA granted the first pediatric indication for an implantable cardiac monitor. The Linq II can be used in pediatric patients over the age of 2 for up to 4.5 years of long-term, continuous monitoring. 

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The U.S. Food and Drug Administration (FDA) has granted the first pediatric indication for use for an implantable cardiac monitor to Medtronic. The Linq II Insertable Cardiac Monitor (ICM) system is the first such device receive 510(k) clearance for use in pediatric patients over the age of 2 who have heart rhythm abnormalities and require long-term, continuous monitoring.
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FDA grants new pediatric indication for Medtronic Linq II implantable cardiac monitor 

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The U.S. Food and Drug Administration (FDA) has granted the first pediatric indication for use for an implantable cardiac monitor to Medtronic. The Linq II Insertable Cardiac Monitor (ICM) system is the first such device receive 510(k) clearance for use in pediatric patients over the age of 2 who have heart rhythm abnormalities and require long-term, continuous monitoring.
The FDA granted the first pediatric indication for an implantable cardiac monitor. The Linq II can be used in pediatric patients over the age of 2 for up to 4.5 years of long-term, continuous monitoring. 
READ MORE >

Pascal transcatheter mitral repair device performs as well as MitraClip in late-breaking CLASP IID Trial 

Comparison between transcatheter edge-to-edge repair (TEER) devices found Pascal was non-inferior compared with MitraClip in the CLASP IID pivotal trial.

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The Pascal transcatheter mitral valve repair system. Similar to the latest version of the MitraClip, the Pascal can operate each leaflet independently to grasp the mitral valve leaflets. Results of the CLASP IID trial at #TCT2022.
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Pascal transcatheter mitral repair device performs as well as MitraClip in late-breaking CLASP IID Trial 

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The Pascal transcatheter mitral valve repair system. Similar to the latest version of the MitraClip, the Pascal can operate each leaflet independently to grasp the mitral valve leaflets. Results of the CLASP IID trial at #TCT2022.
Comparison between transcatheter edge-to-edge repair (TEER) devices found Pascal was non-inferior compared with MitraClip in the CLASP IID pivotal trial.
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Ultrasound guidance for femoral access did not reduce bleeding or vascular complications in TCT late-breaker

The UNIVERSAL Trial, one of the largest multicenter randomized trials comparing ultrasound with fluoroscopic guidance vs. fluoroscopic guidance alone, found there was no reduction in major vascular access complications. 

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Use of ultrasound to guide needles used for femoral vascular access for cath lab procedures can help reduce bleeding and vascular complications. But the Universal Trial at TCT 2022 showed no difference. Image courtesy of Sonosite
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Ultrasound guidance for femoral access did not reduce bleeding or vascular complications in TCT late-breaker

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Use of ultrasound to guide needles used for femoral vascular access for cath lab procedures can help reduce bleeding and vascular complications. But the Universal Trial at TCT 2022 showed no difference. Image courtesy of Sonosite
The UNIVERSAL Trial, one of the largest multicenter randomized trials comparing ultrasound with fluoroscopic guidance vs. fluoroscopic guidance alone, found there was no reduction in major vascular access complications. 
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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.
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Featured Articles

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.
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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 >

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 >

In Case You Missed It

Cardiologists identify a potential new side effect of monkeypox: acute myocarditis

A 31-year-old patient developed acute myocarditis shortly after the onset of monkeypox symptoms. The team that treated him shared their story in a new case study.

READ MORE >
monkey_pox_nih_image.png
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Cardiologists identify a potential new side effect of monkeypox: acute myocarditis

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monkey_pox_nih_image.png
A 31-year-old patient developed acute myocarditis shortly after the onset of monkeypox symptoms. The team that treated him shared their story in a new case study.
READ MORE >

New expert guidelines highlight the importance of quickly diagnosing and treating CIED infections

Though removal of the affected CIED is typically the smartest treatment option—and one supported by specialty groups all over the world—a majority of patients keep living with the device, often resulting in hospitalization or even death.

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New expert guidelines highlight the importance of quickly diagnosing and treating CIED infections

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Though removal of the affected CIED is typically the smartest treatment option—and one supported by specialty groups all over the world—a majority of patients keep living with the device, often resulting in hospitalization or even death.
READ MORE >

In Other News

Improving the diagnostic value of portable imaging: Experts propose 3 interventions

After experts from one institution evaluated 500 portable chest x-rays completed during the summer of 2021, it was revealed that 46.2% of the images obtained were problematic, requiring the imaging to be repeated. 

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Chest MRI
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Improving the diagnostic value of portable imaging: Experts propose 3 interventions

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Chest MRI
After experts from one institution evaluated 500 portable chest x-rays completed during the summer of 2021, it was revealed that 46.2% of the images obtained were problematic, requiring the imaging to be repeated. 
READ MORE >

Judge approves UnitedHealth Group’s planned acquisition of Change

UnitedHealth Group can move ahead with its planned $13 billion acquisition of Change Healthcare after a district court shot down the Department of Justice’s attempt to block the transaction.

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A gavel and a stethoscope
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Judge approves UnitedHealth Group’s planned acquisition of Change

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A gavel and a stethoscope
UnitedHealth Group can move ahead with its planned $13 billion acquisition of Change Healthcare after a district court shot down the Department of Justice’s attempt to block the transaction.
READ MORE >

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