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Structural Heart Disease Highlights: A close look at the TRILUMINATE trial | Key research in interventional cardiology

News You Need to Know Today
Structural Heart Disease Highlights: A close look at the TRILUMINATE trial | Key research in interventional cardiology
Wednesday, April 12, 2023
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Editor's Choice: Structural Heart Disease

TRILUMINATE trial may pave the way for FDA clearance for tricuspid valve clip device

Paul Sorajja, MD, discusses the late-breaking TRILUMINATE pivotal trial at ACC.23 and how tricuspid TEER performed against the current standard of care using medical therapy.

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Paul Sorajja, MD, director, Center for Valve and Structural Heart Disease, Minneapolis Heart Institute, Abbott Northwestern Hospital, was the principal investigator for the late-breaking TRILUMINATE pivotal trial at the American College of Cardiology (ACC) 2023 meeting and explains details of this landmark trial. #ACC #ACC23 #triluminate
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TRILUMINATE trial may pave the way for FDA clearance for tricuspid valve clip device

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Paul Sorajja, MD, director, Center for Valve and Structural Heart Disease, Minneapolis Heart Institute, Abbott Northwestern Hospital, was the principal investigator for the late-breaking TRILUMINATE pivotal trial at the American College of Cardiology (ACC) 2023 meeting and explains details of this landmark trial. #ACC #ACC23 #triluminate
Paul Sorajja, MD, discusses the late-breaking TRILUMINATE pivotal trial at ACC.23 and how tricuspid TEER performed against the current standard of care using medical therapy.
READ MORE >

5 studies that could make a big impact on interventional cardiology

SCAI President Sunil Rao, MD, spoke with us about some of the key interventional cardiology studies presented at ACC.23 in New Orleans. 

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SCAI President Sunil Rao explains what he saw as the top 5 interventional studies at ACC23. #SCAI #ACC #ACC23
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5 studies that could make a big impact on interventional cardiology

Share on Twitter Share on Facebook Share on Linkedin
SCAI President Sunil Rao explains what he saw as the top 5 interventional studies at ACC23. #SCAI #ACC #ACC23
SCAI President Sunil Rao, MD, spoke with us about some of the key interventional cardiology studies presented at ACC.23 in New Orleans. 
READ MORE >

Abbott’s new surgical solution for aortic valve disease gains FDA approval

The newly approved valve is the latest addition to Abbott’s Epic surgical valve platform.

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Abbott Epic Max heart valve for aortic valve disease
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Abbott’s new surgical solution for aortic valve disease gains FDA approval

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Abbott Epic Max heart valve for aortic valve disease
The newly approved valve is the latest addition to Abbott’s Epic surgical valve platform.
READ MORE >

Shockwave Medical launches new IVL catheter for challenging lesions in US

After its initial release was limited to certain customers, the new-look catheter is now available in four different sizes throughout the United States.

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Shockwave L6 Peripheral IVL Catheter Shockwave Medical
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Shockwave Medical launches new IVL catheter for challenging lesions in US

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Shockwave L6 Peripheral IVL Catheter Shockwave Medical
After its initial release was limited to certain customers, the new-look catheter is now available in four different sizes throughout the United States.
READ MORE >

SCAI and HRS release expert consensus on transcatheter left atrial appendage occlusion

One of the new recommendations is to conduct baseline imaging with TEE or cardiac CT.

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Images from the consensus document showing the proper left atrial appendage (LAA) sizing assessment for a transcatheter occluder device using transesophageal echo (TEE). Sizing and evaluation for pre-existing thrombus in the LAA also can be performed using cardiac CT.
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SCAI and HRS release expert consensus on transcatheter left atrial appendage occlusion

Share on Twitter Share on Facebook Share on Linkedin
Images from the consensus document showing the proper left atrial appendage (LAA) sizing assessment for a transcatheter occluder device using transesophageal echo (TEE). Sizing and evaluation for pre-existing thrombus in the LAA also can be performed using cardiac CT.
One of the new recommendations is to conduct baseline imaging with TEE or cardiac CT.
READ MORE >

In Case You Missed It

FDA warns that early deterioration is possible with Abbott’s Trifecta heart valves

Early SVD has been reported in these devices, particularly three to four years after implantation. According to the FDA, this has resulted in surgical replacement procedures and transcatheter valve-in-valve interventions. In some cases, the patient died.

READ MORE >
Abbott and the U.S. Food and Drug Administration (FDA) are warning healthcare providers about the potential risk of early structural valve deterioration (SVD) with Abbott’s line of Trifecta bioprosthetic heart valves. This includes the original Trifecta valve and the Trifecta GT, which are both designed to treat disease, damaged or malfunctioning aortic heart valves.
Share on Twitter Share on Facebook Share on Linkedin

FDA warns that early deterioration is possible with Abbott’s Trifecta heart valves

Share on Twitter Share on Facebook Share on Linkedin
Abbott and the U.S. Food and Drug Administration (FDA) are warning healthcare providers about the potential risk of early structural valve deterioration (SVD) with Abbott’s line of Trifecta bioprosthetic heart valves. This includes the original Trifecta valve and the Trifecta GT, which are both designed to treat disease, damaged or malfunctioning aortic heart valves.
Early SVD has been reported in these devices, particularly three to four years after implantation. According to the FDA, this has resulted in surgical replacement procedures and transcatheter valve-in-valve interventions. In some cases, the patient died.
READ MORE >

Medtronic relaunches Harmony TPV system after 2022 recall

The device, which gained FDA approval in 2021, was part of a voluntary recall in 2022 due to stability concerns. Medtronic worked with the FDA to address the issue, and the Harmony TPV is once again available throughout the United States. 

READ MORE >
The Medtronic Harmony transcatheter pulmonary valve on display at ACC 2022. The U.S. Food and Drug Administration (FDA) has announced that Medtronic is recalling the delivery catheter from its Harmony transcatheter pulmonary valve (TPV) system due to a risk of the piece breaking during use.
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Medtronic relaunches Harmony TPV system after 2022 recall

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The Medtronic Harmony transcatheter pulmonary valve on display at ACC 2022. The U.S. Food and Drug Administration (FDA) has announced that Medtronic is recalling the delivery catheter from its Harmony transcatheter pulmonary valve (TPV) system due to a risk of the piece breaking during use.
The device, which gained FDA approval in 2021, was part of a voluntary recall in 2022 due to stability concerns. Medtronic worked with the FDA to address the issue, and the Harmony TPV is once again available throughout the United States. 
READ MORE >

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