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News You Need to Know Today
June's Top 10 Stories: TAVR controversy | FDA approves colchicine for CVD | Key recalls | Much more!
Thursday, July 6, 2023
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The Month in Review

Editor's Note:

When reviewing our most popular stories from June, one thing is crystal clear: TAVR remains a hugely important topic among cardiologists and other cardiology professionals. New studies and technologies are constantly emerging in the world of TAVR, and we work to cover as many of those updates as possible.

Other big stories last month focused on the FDA’s approval of colchicine, the first anti-inflammatory drug for cardiovascular disease, and a Class I recall of certain Impella heart pumps. These stories highlight yet again how quickly things can change in cardiology. When will the next big story drop? Stay tuned to find out. As always, thank you for reading. - Michael Walter | Editor

Editor's Note:

When reviewing our most popular stories from June, one thing is crystal clear: TAVR remains a hugely important topic among cardiologists and other cardiology professionals. New studies and technologies are constantly emerging in the world of TAVR, and we work to cover as many of those updates as possible. Other big stories last month focused on the FDA’s approval of colchicine, the first anti-inflammatory drug for cardiovascular disease, and a Class I recall of certain Impella heart pumps. These stories highlight yet again how quickly things can change in cardiology. When will the next big story drop? Stay tuned to find out. As always, thank you for reading. - Michael Walter | Editor

TAVR controversy: Surgeon fired after saying cardiologist treated patients without proper credentials

An Ohio doctor allegedly performed multiple procedures without the proper credentials. A vascular surgeon is now out of work for sharing the story with a local media outlet. 

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TAVR controversy: Surgeon fired after saying cardiologist treated patients without proper credentials

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An Ohio doctor allegedly performed multiple procedures without the proper credentials. A vascular surgeon is now out of work for sharing the story with a local media outlet. 
READ MORE >

FDA approves colchicine, the first anti-inflammatory drug for treating cardiovascular disease

The FDA's approval of colchicine, which is marketed and sold under the name Lodoco, is expected to have a big impact on cardiac care and outcomes.

READ MORE >
The U.S. Food and Drug Administration (FDA) priority review, the FDA has cleared the Agepha Pharma USA LLC's drug Lodoco (colchicine) as the first anti-inflammatory atheroprotective cardiovascular treatment. Colchicine prevents coronary artery plaque inflammation, heart inflammation. Colchicine for coronary artery disease. Colchicine for coronary inflammation FDA Approves Colchicine for Decreasing CV Events FDA Approves Colchicine for decreasing inflammation caused by coronary atherosclerosis.
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FDA approves colchicine, the first anti-inflammatory drug for treating cardiovascular disease

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The U.S. Food and Drug Administration (FDA) priority review, the FDA has cleared the Agepha Pharma USA LLC's drug Lodoco (colchicine) as the first anti-inflammatory atheroprotective cardiovascular treatment. Colchicine prevents coronary artery plaque inflammation, heart inflammation. Colchicine for coronary artery disease. Colchicine for coronary inflammation FDA Approves Colchicine for Decreasing CV Events FDA Approves Colchicine for decreasing inflammation caused by coronary atherosclerosis.
The FDA's approval of colchicine, which is marketed and sold under the name Lodoco, is expected to have a big impact on cardiac care and outcomes.
READ MORE >

Cardiologist kills himself after starting antibiotic, prompting coroner to share concerns

The coroner is concerned that the medication's rare side effects do not receive enough attention when it is prescribed to patients. 

READ MORE >
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Cardiologist kills himself after starting antibiotic, prompting coroner to share concerns

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The coroner is concerned that the medication's rare side effects do not receive enough attention when it is prescribed to patients. 
READ MORE >

FDA warning letter: iRhythm committed multiple violations, failed to report patient deaths in time

“It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA,” according to the warning letter. These issues, the agency added, “may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.”

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Zio AT mobile cardiac telemetry device
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FDA warning letter: iRhythm committed multiple violations, failed to report patient deaths in time

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Zio AT mobile cardiac telemetry device
“It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA,” according to the warning letter. These issues, the agency added, “may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.”
READ MORE >

FDA announces recall of certain Impella heart pumps after 3 patient injuries, nearly 200 complaints

The FDA has labeled this as a Class I recall, which means using these devices can lead to significant injuries, including death.

READ MORE >
Recall | Product recall
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FDA announces recall of certain Impella heart pumps after 3 patient injuries, nearly 200 complaints

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Recall | Product recall
The FDA has labeled this as a Class I recall, which means using these devices can lead to significant injuries, including death.
READ MORE >

Rethinking SAVR in the TAVR era: New Cleveland Clinic study explores data from nearly 3,500 patients

SAVR may be even safer for low-risk patients than previously believed, according to new research published in the Journal of Thoracic and Cardiovascular Surgery. What does this tell us about patient care going forward?

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Rethinking SAVR in the TAVR era: New Cleveland Clinic study explores data from nearly 3,500 patients

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SAVR may be even safer for low-risk patients than previously believed, according to new research published in the Journal of Thoracic and Cardiovascular Surgery. What does this tell us about patient care going forward?
READ MORE >

FDA announces recall of more than 250,000 interventional devices due to risk of catheter separation

The FDA has said this is a Class I recall, which means using the devices “may cause serious injuries or death.” A total of 18 injuries have been reported so far. 

READ MORE >
Recall | Product recall
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FDA announces recall of more than 250,000 interventional devices due to risk of catheter separation

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Recall | Product recall
The FDA has said this is a Class I recall, which means using the devices “may cause serious injuries or death.” A total of 18 injuries have been reported so far. 
READ MORE >

Cardiologists perform world’s first TAVR with new ultra-low profile valve

The 88-year-old patient was originally not seen as a viable candidate for TAVR or surgery.

READ MORE >
Valve Medical's Xemed TAVR valve. Xemed TAVR System was developed by Valve Medical, a wholly owned subsidiary of Medinol focused on treating structural heart disease. It features a modular two-piece design and can be implanted using a standard 12 French sheath.
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Cardiologists perform world’s first TAVR with new ultra-low profile valve

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Valve Medical's Xemed TAVR valve. Xemed TAVR System was developed by Valve Medical, a wholly owned subsidiary of Medinol focused on treating structural heart disease. It features a modular two-piece design and can be implanted using a standard 12 French sheath.
The 88-year-old patient was originally not seen as a viable candidate for TAVR or surgery.
READ MORE >

Balloon-expandable valves deliver better short-term TAVR outcomes than self-expandable valves

A new meta-analysis, published in Frontiers in Cardiovascular Medicine, focused on data from nearly 3,000 patients with severe symptomatic aortic stenosis.

READ MORE >
The Edwards Lifesciences Sapien transcatheter aortic valve replacement (TAVR) device in a heart model used to show patients how the device works.
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Balloon-expandable valves deliver better short-term TAVR outcomes than self-expandable valves

Share on Twitter Share on Facebook Share on Linkedin
The Edwards Lifesciences Sapien transcatheter aortic valve replacement (TAVR) device in a heart model used to show patients how the device works.
A new meta-analysis, published in Frontiers in Cardiovascular Medicine, focused on data from nearly 3,000 patients with severe symptomatic aortic stenosis.
READ MORE >

Top 20 children’s hospitals for cardiology and heart surgery

Did your facility make the cut? For its 2023-2024 list, U.S. News and World Report evaluated data from 119 hospitals and surveyed thousands of pediatric specialists.

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Top 20 children’s hospitals for cardiology and heart surgery

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Did your facility make the cut? For its 2023-2024 list, U.S. News and World Report evaluated data from 119 hospitals and surveyed thousands of pediatric specialists.
READ MORE >

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