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May's Top Stories: Big news from Boston Scientific | PFA & heart damage | First TAVR valves approved for asymptomatic patients

News You Need to Know Today
May's Top Stories: Big news from Boston Scientific | PFA & heart damage | First TAVR valves approved for asymptomatic patients
Tuesday, June 3, 2025
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The Month in Review

Boston Scientific pulls plug on TAVR devices after failing to gain FDA approval

After years of trying to catch up with the competition, Boston Scientific is moving on. The company is no longer seeking approval from the FDA or any other regulatory agencies for these devices, and all global sales have been discontinued.

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Boston Scientific pulls plug on TAVR devices after failing to gain FDA approval

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pull plug electric socket
After years of trying to catch up with the competition, Boston Scientific is moving on. The company is no longer seeking approval from the FDA or any other regulatory agencies for these devices, and all global sales have been discontinued.
READ MORE >

Johnson & Johnson MedTech ordered to pay $147M for antitrust violations

The company told Cardiovascular Business it respectfully disagrees with the jury's decision and is evaluating all possible legal options going forward. The Association of Medical Device Reprocessors, meanwhile, celebrated the news.

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money court scale of justice ruling legal settlement
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Johnson & Johnson MedTech ordered to pay $147M for antitrust violations

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money court scale of justice ruling legal settlement
The company told Cardiovascular Business it respectfully disagrees with the jury's decision and is evaluating all possible legal options going forward. The Association of Medical Device Reprocessors, meanwhile, celebrated the news.
READ MORE >

PFA associated with elevated risk of heart damage, real-world data show

Patient outcomes do not appear to be negatively impacted by these risks, researchers noted. The new data were presented at Heart Rhythm 2025 and published in JACC: Clinical Electrophysiology.

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PFA associated with elevated risk of heart damage, real-world data show

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Patient outcomes do not appear to be negatively impacted by these risks, researchers noted. The new data were presented at Heart Rhythm 2025 and published in JACC: Clinical Electrophysiology.
READ MORE >

Tirzepatide bests semaglutide in patients with type 2 diabetes, kidney disease and heart failure

Researchers examined data from more than 9,000 patients, sharing their findings at SCAI 2025.

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tirzepatide injections Zepbound Eli Lilly. The U.S. Food and Drug Administration (FDA) cleared Eli Lilly and Company’s tirzepatide injections for chronic weight management in adult patients who are obese, overweight or present with at least one weight-related condition such as high blood pressure or high cholesterol. These weekly injections are being sold and distributed under the brand name Zepbound. Tirzepatide is also used in Mounjaro, FDA cleared in 2022 for improving glycemic control in adults.
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Tirzepatide bests semaglutide in patients with type 2 diabetes, kidney disease and heart failure

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tirzepatide injections Zepbound Eli Lilly. The U.S. Food and Drug Administration (FDA) cleared Eli Lilly and Company’s tirzepatide injections for chronic weight management in adult patients who are obese, overweight or present with at least one weight-related condition such as high blood pressure or high cholesterol. These weekly injections are being sold and distributed under the brand name Zepbound. Tirzepatide is also used in Mounjaro, FDA cleared in 2022 for improving glycemic control in adults.
Researchers examined data from more than 9,000 patients, sharing their findings at SCAI 2025.
READ MORE >

FDA wants new heart damage warnings added to COVID-19 vaccines

COVID-19 vaccines are associated with a very low risk of myocarditis and/or pericarditis, primarily in young adults. The long-term impact of this risk has been the subject of many studies and debates over the years. One side says that the benefits of vaccination far outweigh the risks, and the other side says that even the smallest risk of heart damage is too high.

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COVID-19 vaccine vaccination myocarditis heart damage inflammation RSNA imaging radiology cardiology
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FDA wants new heart damage warnings added to COVID-19 vaccines

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COVID-19 vaccine vaccination myocarditis heart damage inflammation RSNA imaging radiology cardiology
COVID-19 vaccines are associated with a very low risk of myocarditis and/or pericarditis, primarily in young adults. The long-term impact of this risk has been the subject of many studies and debates over the years. One side says that the benefits of vaccination far outweigh the risks, and the other side says that even the smallest risk of heart damage is too high.
READ MORE >

A victory for early treatment: FDA approves first TAVR valves for asymptomatic severe aortic stenosis

The FDA has approved the balloon-expandable Sapien 3 TAVR platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis. This is the first time the agency has approved any TAVR technology to be used in asymptomatic patients. 

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Sapien 3 Ultra Resilia TAVR valves
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A victory for early treatment: FDA approves first TAVR valves for asymptomatic severe aortic stenosis

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Sapien 3 Ultra Resilia TAVR valves
The FDA has approved the balloon-expandable Sapien 3 TAVR platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis. This is the first time the agency has approved any TAVR technology to be used in asymptomatic patients. 
READ MORE >

Cardiology employment models undergoing a dramatic shift

Gerald G. Blackwell, MD, MBA, MedAxiom's president and CEO, examined how different cardiology employment models look today compared to even a decade ago.

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Gerald Blackwell, president and CEO of MedAxiom, discusses the business of cardiology at ACC 2025.
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Cardiology employment models undergoing a dramatic shift

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Gerald Blackwell, president and CEO of MedAxiom, discusses the business of cardiology at ACC 2025.
Gerald G. Blackwell, MD, MBA, MedAxiom's president and CEO, examined how different cardiology employment models look today compared to even a decade ago.
READ MORE >

Marijuana use linked to blood vessel damage—impact seen with smoking and edibles

"As cannabis legalization increases, it is crucial to understand the public health and clinical implications of marijuana use," researchers wrote in JAMA Cardiology.

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cannabis weed marijuana heart health doctor cardiologist
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Marijuana use linked to blood vessel damage—impact seen with smoking and edibles

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cannabis weed marijuana heart health doctor cardiologist
"As cannabis legalization increases, it is crucial to understand the public health and clinical implications of marijuana use," researchers wrote in JAMA Cardiology.
READ MORE >

CCTA shows colchicine's impact on atherosclerosis progression

Matthew Budoff, MD, detailed new data highlighting CCTA's value when it comes to tracking the progression of coronary atherosclerosis.

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Matthew Budoff explains use of CCTA to track coronary disease plaque progression
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CCTA shows colchicine's impact on atherosclerosis progression

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Matthew Budoff explains use of CCTA to track coronary disease plaque progression
Matthew Budoff, MD, detailed new data highlighting CCTA's value when it comes to tracking the progression of coronary atherosclerosis.
READ MORE >

Cardiologists make history, use new robotic imaging system for first time

Researchers believe a new robotic TEE system could improve the long-term health of interventional echocardiographers in addition to several other key benefits.

READ MORE >
ROB’E Robotic transesophageal echocardiography (TEE). ROB’E, a German startup, has developed a new remote-controlled robotic (RCR) system with these challenges in mind. Users are able to remotely manipulate TEE probes, performing precise movements and even saving specific positions so they can be duplicated as needed.
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Cardiologists make history, use new robotic imaging system for first time

Share on Twitter Share on Facebook Share on Linkedin
ROB’E Robotic transesophageal echocardiography (TEE). ROB’E, a German startup, has developed a new remote-controlled robotic (RCR) system with these challenges in mind. Users are able to remotely manipulate TEE probes, performing precise movements and even saving specific positions so they can be duplicated as needed.
Researchers believe a new robotic TEE system could improve the long-term health of interventional echocardiographers in addition to several other key benefits.
READ MORE >

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