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Ross procedure continues to impress | FDA approves drug label changes | The first operation of its kind | Mental health & CVD

News You Need to Know Today
Ross procedure continues to impress | FDA approves drug label changes | The first operation of its kind | Mental health & CVD
Wednesday, October 15, 2025
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Today's News and Trends

Long-term data highlight Ross procedure's safety, effectiveness in younger patients

TAVR may get more attention, but the Ross procedure has also gained significant momentum in recent years. Ismail El-Hamamsy, MD, PhD, detailed his own team's success with the complex procedure.

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Ismail El-Hamamsy, MD, PhD, director of aortic surgery for the Mount Sinai Health System, explains the long-term outcomes of the Ross procedure, where a diseased aortic valve is surgically replaced with the patient's own pulmonary valve.
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Long-term data highlight Ross procedure's safety, effectiveness in younger patients

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Ismail El-Hamamsy, MD, PhD, director of aortic surgery for the Mount Sinai Health System, explains the long-term outcomes of the Ross procedure, where a diseased aortic valve is surgically replaced with the patient's own pulmonary valve.
TAVR may get more attention, but the Ross procedure has also gained significant momentum in recent years. Ismail El-Hamamsy, MD, PhD, detailed his own team's success with the complex procedure.
READ MORE >

FDA approves labeling changes for fenofibrates due to lack of cardiovascular benefits

The FDA listened to physician feedback and updated its labeling requirements for fenofibrates. These drugs have not been linked to any significant cardiovascular benefits, and clinicians should act accordingly.

READ MORE >
doctor patient elderly check up hospital
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FDA approves labeling changes for fenofibrates due to lack of cardiovascular benefits

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doctor patient elderly check up hospital
The FDA listened to physician feedback and updated its labeling requirements for fenofibrates. These drugs have not been linked to any significant cardiovascular benefits, and clinicians should act accordingly.
READ MORE >

Cardiologists perform first TTVR of its kind on recent heart transplant recipient

When a 50-year-old patient developed severe TR just months after receiving a heart transplant, the safest treatment option was to implant an Evoque TTVR device. 

READ MORE >
Edwards Lifesciences Evoque transcatheter tricuspid valve at TCT 2024. DF
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Cardiologists perform first TTVR of its kind on recent heart transplant recipient

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Edwards Lifesciences Evoque transcatheter tricuspid valve at TCT 2024. DF
When a 50-year-old patient developed severe TR just months after receiving a heart transplant, the safest treatment option was to implant an Evoque TTVR device. 
READ MORE >

How mental health can influence cardiovascular health

Different subtypes of depression are association with specific cardiometabolic diseases, according to new data out of the Netherlands. 

READ MORE >
depression.jpg
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How mental health can influence cardiovascular health

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depression.jpg
Different subtypes of depression are association with specific cardiometabolic diseases, according to new data out of the Netherlands. 
READ MORE >

Featured Articles

Q&A: What cardiologists know and don’t know about pulsed field ablation

Peter Weiss, MD, a veteran electrophysiologist, sat down with Cardiovascular Business to discuss the ongoing rise of pulsed field ablation. While he's impressed with the technology, he says many questions remain about its long-term value. 

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Heart cardiologists doctors surgery
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Q&A: What cardiologists know and don’t know about pulsed field ablation

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Heart cardiologists doctors surgery
Peter Weiss, MD, a veteran electrophysiologist, sat down with Cardiovascular Business to discuss the ongoing rise of pulsed field ablation. While he's impressed with the technology, he says many questions remain about its long-term value. 
READ MORE >

FDA details Class I recalls for more than 1 million pacemakers—software update required

The FDA has finalized new Class I recalls related to ongoing safety concerns with Boston Scientific’s Accolade family of pacemakers. A software update is now available to help address the issue, and an additional update is already in the works.

READ MORE >
the words "FDA recall" on a board
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FDA details Class I recalls for more than 1 million pacemakers—software update required

Share on Twitter Share on Facebook Share on Linkedin
the words "FDA recall" on a board
The FDA has finalized new Class I recalls related to ongoing safety concerns with Boston Scientific’s Accolade family of pacemakers. A software update is now available to help address the issue, and an additional update is already in the works.
READ MORE >

FDA approves key update for Medtronic’s Endurant stent graft system

Going forward, Medtronic can include clinical evidence related to the treatment of ruptured abdominal aortic aneurysms in the device's labeling. This is the first time an EVAR system has received such an approval.

READ MORE >
Endurant stent graft system labeling
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FDA approves key update for Medtronic’s Endurant stent graft system

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Endurant stent graft system labeling
Going forward, Medtronic can include clinical evidence related to the treatment of ruptured abdominal aortic aneurysms in the device's labeling. This is the first time an EVAR system has received such an approval.
READ MORE >

In Case You Missed It

Heart surgeon under investigation after deaths—colleagues questioned her judgement

The surgeon has been accused of performing multiple procedures she was not skilled enough to take on. After undergoing additional training, she could soon return to the job—and her colleagues are not happy.

READ MORE >
Newsweek ranked the 50 best heart hospitals in the world
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Heart surgeon under investigation after deaths—colleagues questioned her judgement

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Newsweek ranked the 50 best heart hospitals in the world
The surgeon has been accused of performing multiple procedures she was not skilled enough to take on. After undergoing additional training, she could soon return to the job—and her colleagues are not happy.
READ MORE >

Trump's $100K visa fee will be bad for heart patients

"There is already a deficit of doctors in the U.S., and this will make it worse," one cardiologist told Cardiovascular Business. Medical societies throughout the country seem to agree. 

READ MORE >
President Trump's presidential proclamation Sept. 19 to implement a $100,000 fee for H-1B visa applications had immediate backlash from dozens of medical societies. Groups like the American Medical Association (AMA) and the American College of Cardiology (ACC) said this will cut off the flow of foreign physicians into the U.S. at a time when we cannot graduate enough American physicians to fill positions in a healthcare system that is facing a rapidly growing physician shortage.
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Trump's $100K visa fee will be bad for heart patients

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President Trump's presidential proclamation Sept. 19 to implement a $100,000 fee for H-1B visa applications had immediate backlash from dozens of medical societies. Groups like the American Medical Association (AMA) and the American College of Cardiology (ACC) said this will cut off the flow of foreign physicians into the U.S. at a time when we cannot graduate enough American physicians to fill positions in a healthcare system that is facing a rapidly growing physician shortage.
"There is already a deficit of doctors in the U.S., and this will make it worse," one cardiologist told Cardiovascular Business. Medical societies throughout the country seem to agree. 
READ MORE >

Medtronic gains key approval for LAA exclusion device

The FDA-cleared device from Medtronic, which arrives pre-loaded on a single-use delivery system, is now set to launch in Europe.

READ MORE >
Medtronic Penditure Left Atrial Appendage (LAA) Exclusion System
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Medtronic gains key approval for LAA exclusion device

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Medtronic Penditure Left Atrial Appendage (LAA) Exclusion System
The FDA-cleared device from Medtronic, which arrives pre-loaded on a single-use delivery system, is now set to launch in Europe.
READ MORE >

In Other News

Medicare contractors mull restricting coverage for key image-guided pain procedure

Five of the seven MACs recently released proposed local coverage determinations, pertaining to peripheral nerve blocks. 

READ MORE >
Medicare money payment
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Medicare contractors mull restricting coverage for key image-guided pain procedure

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Medicare money payment
Five of the seven MACs recently released proposed local coverage determinations, pertaining to peripheral nerve blocks. 
READ MORE >

Physician sues after hospital allegedly ‘lost track’ of pediatric patient, who later died

Sudesh Ebenezer, MD, claims Hurley Medical Center retaliated against him after he expressed concerns over the incident. He is seeking unspecified damages.

READ MORE >
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Physician sues after hospital allegedly ‘lost track’ of pediatric patient, who later died

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Sudesh Ebenezer, MD, claims Hurley Medical Center retaliated against him after he expressed concerns over the incident. He is seeking unspecified damages.
READ MORE >

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