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News You Need to Know Today
FDA announces new recall after 49 deaths | A possible remedy for staffing shortages | BTK implant impresses FDA
Friday, March 22, 2024
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Today's News and Trends

FDA announces new recall impacting more than 66,000 Impella heart pumps after 49 deaths

More than 100 patients have been seriously injured as a result of a significant safety concern. The Impella devices can still be used, according to the recall, if customers refer to Abiomed's new and revised instructions for use.

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The U.S. Food and Drug Administration (FDA) has announced that Abiomed is recalling its instructions for certain Impella left-sided blood pumps due to significant safety concerns. New and revised instructions for use (IFU) have been sent to all affected customers.
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FDA announces new recall impacting more than 66,000 Impella heart pumps after 49 deaths

Share on Twitter Share on Facebook Share on Linkedin
The U.S. Food and Drug Administration (FDA) has announced that Abiomed is recalling its instructions for certain Impella left-sided blood pumps due to significant safety concerns. New and revised instructions for use (IFU) have been sent to all affected customers.
More than 100 patients have been seriously injured as a result of a significant safety concern. The Impella devices can still be used, according to the recall, if customers refer to Abiomed's new and revised instructions for use.
READ MORE >

A possible remedy for cardiology’s staffing shortages: heart failure internists

Internal medicine physicians spend a lot of time working with heart failure patients. A new commentary in JACC: Heart Failure explored the potential impact of providing IM trainees with special training so that they can deliver additional value.

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2024 has been a banner year for structural heart treatments, especially those focused on the tricuspid valve. In February, for example, Edwards Lifesciences made history when its Evoque transcatheter tricuspid valve replacement (TTVR) system became the first device of its kind to gain U.S. Food and Drug Administration (FDA) approval for treating tricuspid regurgitation (TR). Two months later, Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system also gained FDA approval for the treatment of TR.
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A possible remedy for cardiology’s staffing shortages: heart failure internists

Share on Twitter Share on Facebook Share on Linkedin
2024 has been a banner year for structural heart treatments, especially those focused on the tricuspid valve. In February, for example, Edwards Lifesciences made history when its Evoque transcatheter tricuspid valve replacement (TTVR) system became the first device of its kind to gain U.S. Food and Drug Administration (FDA) approval for treating tricuspid regurgitation (TR). Two months later, Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system also gained FDA approval for the treatment of TR.
Internal medicine physicians spend a lot of time working with heart failure patients. A new commentary in JACC: Heart Failure explored the potential impact of providing IM trainees with special training so that they can deliver additional value.
READ MORE >

FDA grants new implant for BTK arterial disease its breakthrough device designation

Elixir Medical's DynamX BTK System is an implantable device that supports BTK vessels after PCI or other interventions.

READ MORE >
FDA grants new Elixir Medical Dynamx implant for BTK arterial disease its breakthrough device designation
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FDA grants new implant for BTK arterial disease its breakthrough device designation

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FDA grants new Elixir Medical Dynamx implant for BTK arterial disease its breakthrough device designation
Elixir Medical's DynamX BTK System is an implantable device that supports BTK vessels after PCI or other interventions.
READ MORE >

Featured Articles

‘Highly effective’: COVID-19 vaccines reduced risk of heart failure, other cardiovascular complications after infection

Researchers explored data from more than 20 million adults for the new study, tracking both short- and long-term outcomes. 

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COVID-19 vaccine vaccination myocarditis heart damage inflammation RSNA imaging radiology cardiology
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‘Highly effective’: COVID-19 vaccines reduced risk of heart failure, other cardiovascular complications after infection

Share on Twitter Share on Facebook Share on Linkedin
COVID-19 vaccine vaccination myocarditis heart damage inflammation RSNA imaging radiology cardiology
Researchers explored data from more than 20 million adults for the new study, tracking both short- and long-term outcomes. 
READ MORE >

FDA approves new hypertension drug months after Idorsia reacquired rights for $343M

Aprocitentan, sold under the brand name Tryvio, is approved for patients with high blood pressure who are already taking other antihypertensive drugs. 

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approved approval
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FDA approves new hypertension drug months after Idorsia reacquired rights for $343M

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approved approval
Aprocitentan, sold under the brand name Tryvio, is approved for patients with high blood pressure who are already taking other antihypertensive drugs. 
READ MORE >

Intermittent fasting may increase risk of death from heart attack, stroke

Time-restricted eating is popular in the United States, but new research suggests it may do more harm than good if taken to certain extremes. 

READ MORE >
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Intermittent fasting may increase risk of death from heart attack, stroke

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Time-restricted eating is popular in the United States, but new research suggests it may do more harm than good if taken to certain extremes. 
READ MORE >

In Case You Missed It

A big win for Wegovy: Weight loss drug semaglutide first in history to gain FDA approval for reducing heart risks

The FDA made a special announcement about its decision, describing the news as "a major advance for public health."

READ MORE >
Weekly doses of semaglutide, a GLP-1 receptor originally developed to treat diabetes, could help approximately 93 million U.S. adults lose weight and reduce their risk of adverse cardiovascular events, according to new research published in Cardiovascular Drugs and Therapy. Novo Nordisk sells and markets subcutaneous treatments of semaglutide 2.4 mg under the brand name Wegovy.
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A big win for Wegovy: Weight loss drug semaglutide first in history to gain FDA approval for reducing heart risks

Share on Twitter Share on Facebook Share on Linkedin
Weekly doses of semaglutide, a GLP-1 receptor originally developed to treat diabetes, could help approximately 93 million U.S. adults lose weight and reduce their risk of adverse cardiovascular events, according to new research published in Cardiovascular Drugs and Therapy. Novo Nordisk sells and markets subcutaneous treatments of semaglutide 2.4 mg under the brand name Wegovy.
The FDA made a special announcement about its decision, describing the news as "a major advance for public health."
READ MORE >

ACC, SCAI say new funding bill did not do enough to limit Medicare reimbursement cuts to cardiology services

President Joe Biden signed a funding bill worth $460 billion on March 9, but it only included partial relief for cardiologists, cardiac surgeons and other cardiology professionals. 

READ MORE >
Medicare data stethoscope healthcare trends graphs finance financials
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ACC, SCAI say new funding bill did not do enough to limit Medicare reimbursement cuts to cardiology services

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Medicare data stethoscope healthcare trends graphs finance financials
President Joe Biden signed a funding bill worth $460 billion on March 9, but it only included partial relief for cardiologists, cardiac surgeons and other cardiology professionals. 
READ MORE >

In Other News

This week in the Change Healthcare hack fallout: 10 notable quotes

“ALPHV/BlackCat and their affiliates haven’t attacked Change Healthcare. This time, they’ve attacked our families.”

READ MORE >
quotation marks
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This week in the Change Healthcare hack fallout: 10 notable quotes

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quotation marks
“ALPHV/BlackCat and their affiliates haven’t attacked Change Healthcare. This time, they’ve attacked our families.”
READ MORE >

FDA clears AI-enhanced 3D heart models generated from MR and CT images

The inHeart models significantly reduce cardiac ablation surgery times.

READ MORE >
The rapid rise of artificial intelligence (AI) has helped cardiologists, radiologists, nurses and other healthcare providers embrace precision medicine in a way that ensures more heart patients are receiving personalized care.
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FDA clears AI-enhanced 3D heart models generated from MR and CT images

Share on Twitter Share on Facebook Share on Linkedin
The rapid rise of artificial intelligence (AI) has helped cardiologists, radiologists, nurses and other healthcare providers embrace precision medicine in a way that ensures more heart patients are receiving personalized care.
The inHeart models significantly reduce cardiac ablation surgery times.
READ MORE >

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