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Week in Review: Catheters recalled after death | Value-based reimbursement | AI & cardiology | TMVR valve impresses FDA

News You Need to Know Today
Week in Review: Catheters recalled after death | Value-based reimbursement | AI & cardiology | TMVR valve impresses FDA
Saturday, May 18, 2024
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This Week’s News

FDA announces new recall of delivery catheters after patient’s death

The recall includes specific lots of five different medical devices used to treat stroke and other neurovascular diseases.

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FDA announces new recall of delivery catheters after patient’s death

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the words "FDA recall" on a board
The recall includes specific lots of five different medical devices used to treat stroke and other neurovascular diseases.
READ MORE >

How the shift to value-based reimbursements could transform cardiology

"I think we really need our cardiologist community to understand the changes that are happening with value-based payment," one expert tells Cardiovascular Business. 

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lex Sandhu, MD, MS, assistant professor of cardiovascular medicine, Stanford University, and cardiologist at the Palo Alto VA. He spoke in the business of cardiology sessions at ACC 2024 and explained how Medicare reimbursements will be moving toward a value based payment model by 2030. #ACC #ACC24 #ACC2024 #CMS #reimbersements #Medicare
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How the shift to value-based reimbursements could transform cardiology

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lex Sandhu, MD, MS, assistant professor of cardiovascular medicine, Stanford University, and cardiologist at the Palo Alto VA. He spoke in the business of cardiology sessions at ACC 2024 and explained how Medicare reimbursements will be moving toward a value based payment model by 2030. #ACC #ACC24 #ACC2024 #CMS #reimbersements #Medicare
"I think we really need our cardiologist community to understand the changes that are happening with value-based payment," one expert tells Cardiovascular Business. 
READ MORE >

FDA announces another new recall involving Abbott’s HeartMate 3 LVADs after 70 injuries, 2 deaths

Abbott issued the new recall after receiving more than 80 reports of blood or air entering the LVAD during implant procedures. Customers can still use these devices, but they are advised to follow specific steps to limit the risk of complications. 

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Product Recall
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FDA announces another new recall involving Abbott’s HeartMate 3 LVADs after 70 injuries, 2 deaths

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Product Recall
Abbott issued the new recall after receiving more than 80 reports of blood or air entering the LVAD during implant procedures. Customers can still use these devices, but they are advised to follow specific steps to limit the risk of complications. 
READ MORE >

Updated balloon-expandable TAVR valve from Edwards outperforming its predecessors

The fifth-generation valve is associated with improved hemodynamic data and a reduced rate of paravalvular leak, according to new research published in JACC: Cardiovascular Interventions and EuroIntervention.

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Edwards Lifesciences Sapien 3 Ultra Resilia TAVR
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Updated balloon-expandable TAVR valve from Edwards outperforming its predecessors

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Edwards Lifesciences Sapien 3 Ultra Resilia TAVR
The fifth-generation valve is associated with improved hemodynamic data and a reduced rate of paravalvular leak, according to new research published in JACC: Cardiovascular Interventions and EuroIntervention.
READ MORE >

Cardiology ranked No. 2 among all specialties with 122 FDA-cleared AI models

Only radiology is associated with more FDA-cleared AI algorithms than cardiology, according to new federal data. 

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Remote ECG access on a smart phone via the Viz.ai Cardio Suite, which enables access to dynamic ECG, echo, MRI, CT images and reports. It also enables automated detection on imaging to alert care teams for STEMI, hypertrophic cardiomyopathy, pulmonary embolism, aortic dissection and abdominal aortic aneurysm, and heart failure.
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Cardiology ranked No. 2 among all specialties with 122 FDA-cleared AI models

Share on Twitter Share on Facebook Share on Linkedin
Remote ECG access on a smart phone via the Viz.ai Cardio Suite, which enables access to dynamic ECG, echo, MRI, CT images and reports. It also enables automated detection on imaging to alert care teams for STEMI, hypertrophic cardiomyopathy, pulmonary embolism, aortic dissection and abdominal aortic aneurysm, and heart failure.
Only radiology is associated with more FDA-cleared AI algorithms than cardiology, according to new federal data. 
READ MORE >

AI-based CAD assessments dramatically improve vascular surgery outcomes

PAD patients evaluated with HeartFlow's noninvasive FFRCT Analysis technology prior to surgery experienced much better outcomes, including a 63% lower risk of all-cause mortality after five years. 

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Performing CT-derived fractional flow reserve (CT-FFR) before transcatheter aortic valve replacement (TAVR) improves the accuracy of coronary CT angiography (CCTA) and helps limit unneeded invasive coronary angiography (ICA), according to a new study published in JACC: Cardiovascular Interventions. Heartflow
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AI-based CAD assessments dramatically improve vascular surgery outcomes

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Performing CT-derived fractional flow reserve (CT-FFR) before transcatheter aortic valve replacement (TAVR) improves the accuracy of coronary CT angiography (CCTA) and helps limit unneeded invasive coronary angiography (ICA), according to a new study published in JACC: Cardiovascular Interventions. Heartflow
PAD patients evaluated with HeartFlow's noninvasive FFRCT Analysis technology prior to surgery experienced much better outcomes, including a 63% lower risk of all-cause mortality after five years. 
READ MORE >

FDA grants breakthrough device designation to new TMVR device from 4C Medical

The supra-annular AltaValve System was designed to treat both primary and secondary mitral regurgitation. It is implanted via transseptal access and positioned above the native mitral valve.

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4C Medical Technologies AltaValve
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FDA grants breakthrough device designation to new TMVR device from 4C Medical

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4C Medical Technologies AltaValve
The supra-annular AltaValve System was designed to treat both primary and secondary mitral regurgitation. It is implanted via transseptal access and positioned above the native mitral valve.
READ MORE >

New hypertrophic cardiomyopathy guidelines highlight importance of exercise, new drug class

HCM is widely underdiagnosed, but the American College of Cardiology and American Heart Association hope their new guidelines can help cardiologists learn more about the potentially fatal condition and improve patient care. 

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heart patient
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New hypertrophic cardiomyopathy guidelines highlight importance of exercise, new drug class

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heart patient
HCM is widely underdiagnosed, but the American College of Cardiology and American Heart Association hope their new guidelines can help cardiologists learn more about the potentially fatal condition and improve patient care. 
READ MORE >

Mammogram findings linked to heightened risk of CVD, type 2 diabetes and hypertension

The new research, presented during ARRS 2024 in Boston, suggests CVD risk models may need to include certain findings identified in routine mammograms. 

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Mammogram findings linked to heightened risk of CVD, type 2 diabetes and hypertension

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woman_receives_mammogram.jpg
The new research, presented during ARRS 2024 in Boston, suggests CVD risk models may need to include certain findings identified in routine mammograms. 
READ MORE >

Cardiologists examine how residual TR after transcatheter tricuspid valve repair impacts survival

Researchers tracked data from more than 600 patients, noting that heart teams may want to reconsider how they classify residual TR after treatment. 

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cardiologist viewing heart data
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Cardiologists examine how residual TR after transcatheter tricuspid valve repair impacts survival

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cardiologist viewing heart data
Researchers tracked data from more than 600 patients, noting that heart teams may want to reconsider how they classify residual TR after treatment. 
READ MORE >

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