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News You Need to Know Today
Week in Review: Procedure kits recalled | FDA requires new warnings | J&J MedTech's legal battle continues | New TAVR tech
Saturday, June 28, 2025
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This Week’s News

FDA declares Class I recall on heart surgery procedure kits from Medline

The news is related to an earlier recall of more than 316,000 Medtronic devices.

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the words "FDA recall" on a board
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FDA declares Class I recall on heart surgery procedure kits from Medline

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the words "FDA recall" on a board
The news is related to an earlier recall of more than 316,000 Medtronic devices.
READ MORE >

FDA finalizes new heart warnings for COVID-19 vaccines

The new warnings, first proposed to Pfizer and Moderna in April, are now officially required by the FDA. They provide additional information about the potential risks of myocarditis and/or pericarditis associated with these vaccines.

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COVID-19 vaccines help reduce the serious coronavirus infections and hospitalizations. Multiple studies have shown that the risk from very rare vaccine side effects are far outweighed by the much greater risk of hospitalization and death due to COVID infections.
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FDA finalizes new heart warnings for COVID-19 vaccines

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COVID-19 vaccines help reduce the serious coronavirus infections and hospitalizations. Multiple studies have shown that the risk from very rare vaccine side effects are far outweighed by the much greater risk of hospitalization and death due to COVID infections.
The new warnings, first proposed to Pfizer and Moderna in April, are now officially required by the FDA. They provide additional information about the potential risks of myocarditis and/or pericarditis associated with these vaccines.
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Johnson & Johnson MedTech faces threat of permanent injunction after losing antitrust case

After being ordered to pay $442 million in damages—a ruling the company has said it may appeal—Johnson & Johnson MedTech is now facing the possibility of a permanent injunction that could impact certain business practices. A hearing is scheduled for July. 

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statue justice legal verdict malpractice case lawsuit scale
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Johnson & Johnson MedTech faces threat of permanent injunction after losing antitrust case

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statue justice legal verdict malpractice case lawsuit scale
After being ordered to pay $442 million in damages—a ruling the company has said it may appeal—Johnson & Johnson MedTech is now facing the possibility of a permanent injunction that could impact certain business practices. A hearing is scheduled for July. 
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Cardiologists, radiologists and surgeons share ‘landmark’ document on assessing prosthetic heart valves with CT

RSNA and several other industry societies have shared a new expert consensus document on the significant value of cardiac CT. Echo remains an effective first-line imaging option, the groups wrote, but CT can make a big impact as well. 

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CT imaging showing structural valve deterioration. An example of structural valve deterioration that shows a biological prosthetic heart valve in the aortic position. There is severe calcification and thickening of the leaflets compatible with structural valve deterioration. 3D VRT (A) and in-plane reconstructions (B). Images and caption courtesy of Budde et al. and RSNA.
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Cardiologists, radiologists and surgeons share ‘landmark’ document on assessing prosthetic heart valves with CT

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CT imaging showing structural valve deterioration. An example of structural valve deterioration that shows a biological prosthetic heart valve in the aortic position. There is severe calcification and thickening of the leaflets compatible with structural valve deterioration. 3D VRT (A) and in-plane reconstructions (B). Images and caption courtesy of Budde et al. and RSNA.
RSNA and several other industry societies have shared a new expert consensus document on the significant value of cardiac CT. Echo remains an effective first-line imaging option, the groups wrote, but CT can make a big impact as well. 
READ MORE >

Surgeons complete first fully robotic heart transplant in US history

The historic procedure was performed in Texas on a 45-year-old patient who had been hospitalized for months with advanced heart failure.

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heart surgery Baylor St. Luke's Medical Center
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Surgeons complete first fully robotic heart transplant in US history

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heart surgery Baylor St. Luke's Medical Center
The historic procedure was performed in Texas on a 45-year-old patient who had been hospitalized for months with advanced heart failure.
READ MORE >

American College of Cardiology now supports early use of medication to treat obesity

The group highlighted the proven effectiveness of these drugs, especially semaglutide and tirzepatide, while noting that eligibility, affordability and availability will still play key roles in any treatment decisions. 

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A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]
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American College of Cardiology now supports early use of medication to treat obesity

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A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]
The group highlighted the proven effectiveness of these drugs, especially semaglutide and tirzepatide, while noting that eligibility, affordability and availability will still play key roles in any treatment decisions. 
READ MORE >

A closer look at world’s first TAVR patient treated with new cerebral embolic protection device

The device covers three vessels at once and can be deployed through the patient's TAVR access site. Researchers shared their first-in-human experience in JACC: Case Reports.

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EnCompass F2 device from Nevada-based EnCompass Technologies. (A) Aortic arch deflector composed of a cylindrical nitinol frame that covers all three vessels supplying blood flow to the brain while allowing passage of the transcatheter aortic valve replacement system through its center. (B) It features an electrospun filter with very small pore size (30 μm average). Images/caption courtesy of JACC: Case Reports and George et al.
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A closer look at world’s first TAVR patient treated with new cerebral embolic protection device

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EnCompass F2 device from Nevada-based EnCompass Technologies. (A) Aortic arch deflector composed of a cylindrical nitinol frame that covers all three vessels supplying blood flow to the brain while allowing passage of the transcatheter aortic valve replacement system through its center. (B) It features an electrospun filter with very small pore size (30 μm average). Images/caption courtesy of JACC: Case Reports and George et al.
The device covers three vessels at once and can be deployed through the patient's TAVR access site. Researchers shared their first-in-human experience in JACC: Case Reports.
READ MORE >

TTVR with Evoque system linked to positive real-world outcomes after 30 days

According to early real-world data, the FDA-approved Evoque TTVR device is associated with positive outcomes when used to treat severe tricuspid regurgitation. 

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The Evoque transcatheter tricuspid valve replacement (TTVR) system for tricuspid regurgitation from Edwards Lifesciences. The Evoque is the first transcatheter tricuspid valve approved by the FDA. It is the first TTVR cleared in the U.S.
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TTVR with Evoque system linked to positive real-world outcomes after 30 days

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The Evoque transcatheter tricuspid valve replacement (TTVR) system for tricuspid regurgitation from Edwards Lifesciences. The Evoque is the first transcatheter tricuspid valve approved by the FDA. It is the first TTVR cleared in the U.S.
According to early real-world data, the FDA-approved Evoque TTVR device is associated with positive outcomes when used to treat severe tricuspid regurgitation. 
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First 250 patients enrolled in transcatheter heart failure device trial to reduce LV size

The first 250 patients has been enrolled in the CORCINCH-HF U.S. pivotal trial evaluating the AccuCinch Transcatheter Left Ventricular Restoration System in patients with HFrEF.

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Ancora Heart AccuCinch Ventricular Restoration System heart failure FDA
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First 250 patients enrolled in transcatheter heart failure device trial to reduce LV size

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Ancora Heart AccuCinch Ventricular Restoration System heart failure FDA
The first 250 patients has been enrolled in the CORCINCH-HF U.S. pivotal trial evaluating the AccuCinch Transcatheter Left Ventricular Restoration System in patients with HFrEF.
READ MORE >

Heart attack deaths are way down after decades of breakthroughs—but other risks have skyrocketed

Researchers explored more than 52 years of data, highlighting several key trends in the Journal of the American Heart Association.

READ MORE >
cardiovascular heart diagnostics
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Heart attack deaths are way down after decades of breakthroughs—but other risks have skyrocketed

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cardiovascular heart diagnostics
Researchers explored more than 52 years of data, highlighting several key trends in the Journal of the American Heart Association.
READ MORE >

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