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TAVR Highlights: Treating patients with nickel allergies | Medtronic receives updated FDA approval | No sedation required?

News You Need to Know Today
TAVR Highlights: Treating patients with nickel allergies | Medtronic receives updated FDA approval | No sedation required?
Wednesday, September 10, 2025
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Editor's Choice: TAVR

TAVR still a safe option for patients with nickel allergies

More research is still needed, as this study only included data from a small number of patients, but TAVR was not linked to any severe adverse events or allergic reactions.

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The Medtronic CoreValve Evolut and the Edwards Lifesciences Sapien 3 TAVR valves.
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TAVR still a safe option for patients with nickel allergies

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The Medtronic CoreValve Evolut and the Edwards Lifesciences Sapien 3 TAVR valves.
More research is still needed, as this study only included data from a small number of patients, but TAVR was not linked to any severe adverse events or allergic reactions.
READ MORE >

Medtronic receives updated FDA approval for redo TAVR

The company also launched a new clinical trial designed to follow redo TAVR patients who present with symptomatic bioprosthetic valve failure for up to five years.

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Medtronic has received U.S. Food and Drug Administration (FDA) approval for its Evolut FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis. The larger coronary access window in the frame of the Evolut FX+. Image courtesy of Medtronic.
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Medtronic receives updated FDA approval for redo TAVR

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Medtronic has received U.S. Food and Drug Administration (FDA) approval for its Evolut FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis. The larger coronary access window in the frame of the Evolut FX+. Image courtesy of Medtronic.
The company also launched a new clinical trial designed to follow redo TAVR patients who present with symptomatic bioprosthetic valve failure for up to five years.
READ MORE >

No sedation required: Local anesthesia enough for most TAVR patients

New data out of ESC Congress 2025 suggest care teams can take a more minimalist approach during a majority of TAVR cases and only treat patients with local anesthesia. In some cases, however, sedation will still be necessary. 

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No sedation required: Local anesthesia enough for most TAVR patients

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New data out of ESC Congress 2025 suggest care teams can take a more minimalist approach during a majority of TAVR cases and only treat patients with local anesthesia. In some cases, however, sedation will still be necessary. 
READ MORE >

TAVR in patients with bicuspid aortic valve stenosis: Does device type matter?

More and more care teams are treating BAV stenosis with TAVR instead of surgical aortic valve replacement. Self-expanding and balloon-expandable valves appear to have their own benefits—as well as their own risks. 

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bicuspid aortic valve disease TAVR
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TAVR in patients with bicuspid aortic valve stenosis: Does device type matter?

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bicuspid aortic valve disease TAVR
More and more care teams are treating BAV stenosis with TAVR instead of surgical aortic valve replacement. Self-expanding and balloon-expandable valves appear to have their own benefits—as well as their own risks. 
READ MORE >

Abbott receives expanded approval for Navitor TAVR system

Abbott's TAVR valve now has CE mark approval for treating low-, intermediate- and high-risk patients who present with symptomatic severe aortic stenosis. The news comes as new data on the valve's safety and effectiveness were just published in JACC: Cardiovascular Interventions.

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Abbott's Navitor TAVR valve
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Abbott receives expanded approval for Navitor TAVR system

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Abbott's Navitor TAVR valve
Abbott's TAVR valve now has CE mark approval for treating low-, intermediate- and high-risk patients who present with symptomatic severe aortic stenosis. The news comes as new data on the valve's safety and effectiveness were just published in JACC: Cardiovascular Interventions.
READ MORE >

Hemodynamic deterioration 1 year after TAVR found in 6% of patients

Hemodynamic valve deterioration after one year was more common in patients with a small aortic annulus. In fact, receiving a larger valve was linked to a “protective” quality that appeared to help keep the risk of such complications to a minimum.

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Illustration of cardiologists going through the certification process. American College of Cardiology President B. Hadley Wilson, MD, discussed why the ACC and other leading cardiology groups are so eager to create a new, independent medical board. This has been a long-term goal for many years, he said, and now it may become a reality. 
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Hemodynamic deterioration 1 year after TAVR found in 6% of patients

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Illustration of cardiologists going through the certification process. American College of Cardiology President B. Hadley Wilson, MD, discussed why the ACC and other leading cardiology groups are so eager to create a new, independent medical board. This has been a long-term goal for many years, he said, and now it may become a reality. 
Hemodynamic valve deterioration after one year was more common in patients with a small aortic annulus. In fact, receiving a larger valve was linked to a “protective” quality that appeared to help keep the risk of such complications to a minimum.
READ MORE >

FTC challenge to Edwards JenaValve acquisition could delay FDA approval

Edwards Lifesciences asked the U.S. Federal Trade Commission (FTC) this week to dismiss the complaint against the company's acquisition of JenaValve this week. A healthcare market analysis firm also said the FTC actions will likely impact the timing of an FDA clearance of the Trilogy heart valve.

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jenavalve TAVR valve for aortic regurgitation acquired by Edwards
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FTC challenge to Edwards JenaValve acquisition could delay FDA approval

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jenavalve TAVR valve for aortic regurgitation acquired by Edwards
Edwards Lifesciences asked the U.S. Federal Trade Commission (FTC) this week to dismiss the complaint against the company's acquisition of JenaValve this week. A healthcare market analysis firm also said the FTC actions will likely impact the timing of an FDA clearance of the Trilogy heart valve.
READ MORE >

In Case You Missed It

Stroke risk after TAVR still much higher for female patients

Women are associated with a significantly higher rate of in-hospital disabling strokes than men, according to a new study of nearly 380,000 TAVR patients. What can cardiologists do to help limit these complications? 

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stroke brain dementia alzheimer's puzzle mental health
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Stroke risk after TAVR still much higher for female patients

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stroke brain dementia alzheimer's puzzle mental health
Women are associated with a significantly higher rate of in-hospital disabling strokes than men, according to a new study of nearly 380,000 TAVR patients. What can cardiologists do to help limit these complications? 
READ MORE >

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