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TAVR Highlights: A big approval for Medtronic | Boston Scientific pulls the plug | Same-day discharge linked to key benefits

News You Need to Know Today
TAVR Highlights: A big approval for Medtronic | Boston Scientific pulls the plug | Same-day discharge linked to key benefits
Thursday, June 5, 2025
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Editor's Choice: TAVR

Medtronic gains a key approval for Evolut TAVR valves

More patients can now undergo redo TAVR with a Medtronic valve than ever before.

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Medtronic Evolut FX TAVR valve. Medtronic has received an additional CE mark approval for its Evolut Pro+ and FX transcatheter aortic valve replacement (TAVR) valves; they can now be used for redo TAVR in addition to traditional TAVR procedures.
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Medtronic gains a key approval for Evolut TAVR valves

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Medtronic Evolut FX TAVR valve. Medtronic has received an additional CE mark approval for its Evolut Pro+ and FX transcatheter aortic valve replacement (TAVR) valves; they can now be used for redo TAVR in addition to traditional TAVR procedures.
More patients can now undergo redo TAVR with a Medtronic valve than ever before.
READ MORE >

Answering key follow-up questions after the FDA approved TAVR in asymptomatic patients

The approval of certain TAVR valves to be used in asymptomatic patients is expected to make a significant impact on patient care going forward. 

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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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Answering key follow-up questions after the FDA approved TAVR in asymptomatic patients

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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 approval of certain TAVR valves to be used in asymptomatic patients is expected to make a significant impact on patient care going forward. 
READ MORE >

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 >

Heart patients benefit when cardiologists follow a standardized TAVR protocol

Using a standardized approach, including the cusp overlap technique, is associated with improved patient outcomes when implanting Medtronic's self-expanding TAVR valves. Researchers tracked data from more than 600 patients treated all over the world, presenting their findings in JSCAI.

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Newsweek ranked the 50 best heart hospitals in the world
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Heart patients benefit when cardiologists follow a standardized TAVR protocol

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Newsweek ranked the 50 best heart hospitals in the world
Using a standardized approach, including the cusp overlap technique, is associated with improved patient outcomes when implanting Medtronic's self-expanding TAVR valves. Researchers tracked data from more than 600 patients treated all over the world, presenting their findings in JSCAI.
READ MORE >

Same-day discharge after TAVR linked to positive outcomes

When low-risk patients undergo transfemoral TAVR, they may be able to go home without spending a single night at the hospital.

READ MORE >
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Same-day discharge after TAVR linked to positive outcomes

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When low-risk patients undergo transfemoral TAVR, they may be able to go home without spending a single night at the hospital.
READ MORE >

AI predicts LBBB risk in TAVR patients prior to treatment

The authors tested out a variety of machine learning techniques, including large language models and more traditional algorithms. They focused on data that can be gathered prior to treatment, ensuring cardiologists know as much as possible before the procedure.

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artificial intelligence heart AI
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AI predicts LBBB risk in TAVR patients prior to treatment

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artificial intelligence heart AI
The authors tested out a variety of machine learning techniques, including large language models and more traditional algorithms. They focused on data that can be gathered prior to treatment, ensuring cardiologists know as much as possible before the procedure.
READ MORE >

How anticoagulants may impact a patient’s risk of gastrointestinal bleeding after TAVR

Researchers tracked the rates of major gastrointestinal bleeding in patients with AFib randomized to receive edoxaban or a vitamin K antagonist after a successful TAVR procedure.

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How anticoagulants may impact a patient’s risk of gastrointestinal bleeding after TAVR

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heart drugs with stethoscope
Researchers tracked the rates of major gastrointestinal bleeding in patients with AFib randomized to receive edoxaban or a vitamin K antagonist after a successful TAVR procedure.
READ MORE >

TAVR and SAVR deliver similar outcomes for patients with low-flow, low-gradient aortic stenosis

Paravalvular leak was more common after TAVR, as one may expect, but that was the only notable difference between the two aortic valve replacement strategies. The study's authors did highlight the importance of additional research, including larger studies with longer follow-up periods.

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Doctor patient
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TAVR and SAVR deliver similar outcomes for patients with low-flow, low-gradient aortic stenosis

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Doctor patient
Paravalvular leak was more common after TAVR, as one may expect, but that was the only notable difference between the two aortic valve replacement strategies. The study's authors did highlight the importance of additional research, including larger studies with longer follow-up periods.
READ MORE >

A new use for IVL: helping cardiologists secure transcarotid access for TAVR

IVL can do more than help prep patients for PCI. In fact, one heart team used Shockwave Medical's IVL technology to secure access for a high-risk TAVR patient.

READ MORE >
Intravascular lithotripsy IVL carotid artery TAVR. (A) Invasive angiography of the right common carotid artery. (B) Invasive angiography of the brachiocephalic artery (note the heavily calcified aortic arch). (C and D) Intravascular lithotripsy (IVL) treatment of the brachiocephalic artery to the mid common carotid artery using a 7.0 × 60 mm × 135 cm Shockwave IVL balloon. (E) Successful deployment of a 23 mm SAPIEN 3 Ultra 9750 TFX Aortic Valve. Images courtesy of JACC: Case Reports
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A new use for IVL: helping cardiologists secure transcarotid access for TAVR

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Intravascular lithotripsy IVL carotid artery TAVR. (A) Invasive angiography of the right common carotid artery. (B) Invasive angiography of the brachiocephalic artery (note the heavily calcified aortic arch). (C and D) Intravascular lithotripsy (IVL) treatment of the brachiocephalic artery to the mid common carotid artery using a 7.0 × 60 mm × 135 cm Shockwave IVL balloon. (E) Successful deployment of a 23 mm SAPIEN 3 Ultra 9750 TFX Aortic Valve. Images courtesy of JACC: Case Reports
IVL can do more than help prep patients for PCI. In fact, one heart team used Shockwave Medical's IVL technology to secure access for a high-risk TAVR patient.
READ MORE >

Intra-annular TAVR valves from Edwards Lifesciences and Abbott deliver similar 1-year outcomes

Each valve was associated with certain benefits, but one-year outcomes were largely similar. 

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Edwards Lifesciences SAPIEN 3 Ultra TAVR valve
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Intra-annular TAVR valves from Edwards Lifesciences and Abbott deliver similar 1-year outcomes

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Edwards Lifesciences SAPIEN 3 Ultra TAVR valve
Each valve was associated with certain benefits, but one-year outcomes were largely similar. 
READ MORE >

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