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News You Need to Know Today
Week in Review: Medicare covers renal denervation | In-person coverage of TCT 2025 | Patient sues Abbott | FDA clears software
Saturday, November 1, 2025
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This Week’s News

Medicare now covers renal denervation for patients with uncontrolled hypertension

This decision expands access to renal denervation to many more patients throughout the United States. Recor Medical and Medtronic both gained FDA approval for their RDN systems in 2023, and other vendors are actively developing their own treatment options.

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The U.S. Food and Drug Administration (FDA) has approved Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) system for uncontrolled hypertension. The Recor system gained FDA clearance in November 2023.
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Medicare now covers renal denervation for patients with uncontrolled hypertension

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The U.S. Food and Drug Administration (FDA) has approved Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) system for uncontrolled hypertension. The Recor system gained FDA clearance in November 2023.
This decision expands access to renal denervation to many more patients throughout the United States. Recor Medical and Medtronic both gained FDA approval for their RDN systems in 2023, and other vendors are actively developing their own treatment options.
READ MORE >

New drug recall includes more than 140K bottles of popular statin

According to the FDA, the drugs are not dissolving correctly. This can impact their ability to lower a patient’s cholesterol as intended.

READ MORE >
heart drugs with stethoscope
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New drug recall includes more than 140K bottles of popular statin

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heart drugs with stethoscope
According to the FDA, the drugs are not dissolving correctly. This can impact their ability to lower a patient’s cholesterol as intended.
READ MORE >

Cardiologist seeks answers about Trump’s health after MRI

After President Donald Trump told reporters he underwent an MRI—adding that the results were “perfect”—it remains unclear why, exactly, the scan was ordered in the first place.

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President Donald Trump with MAGA hat, White House press photo
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Cardiologist seeks answers about Trump’s health after MRI

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President Donald Trump with MAGA hat, White House press photo
After President Donald Trump told reporters he underwent an MRI—adding that the results were “perfect”—it remains unclear why, exactly, the scan was ordered in the first place.
READ MORE >

Key takeaways for interventional cardiology from TCT 2025

B. Hadley Wilson, MD, talked to Cardiovascular Business about several standout late-breaking clinical trials presented at TCT 2025. Topics of those trials included drug-coated balloons, TAVR valve durability, pulmonary embolism treatments and much more.

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Hadley Wilson, MD, MACC, executive vice chair of Atrium Health Sanger Heart and Vascular Institute, and a clinical professor of medicine at Wake Forest University School of Medicine, shares what he felt were the most important clinical trials presented at the TCT 2025.
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Key takeaways for interventional cardiology from TCT 2025

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Hadley Wilson, MD, MACC, executive vice chair of Atrium Health Sanger Heart and Vascular Institute, and a clinical professor of medicine at Wake Forest University School of Medicine, shares what he felt were the most important clinical trials presented at the TCT 2025.
B. Hadley Wilson, MD, talked to Cardiovascular Business about several standout late-breaking clinical trials presented at TCT 2025. Topics of those trials included drug-coated balloons, TAVR valve durability, pulmonary embolism treatments and much more.
READ MORE >

PARTNER 3 update: TAVR still comparable to SAVR in low-risk patients after 7 years

PARTNER 3 has been one of the most closely watched clinical trials in cardiology for many years now. Michael J. Mack, MD, presented a seven-year update during a packed session at TCT 2025. 

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Michael J. Mack, MD, discusses his team's seven-year update to the PARTNER 3 trial at TCT 2025 in San Francisco.
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PARTNER 3 update: TAVR still comparable to SAVR in low-risk patients after 7 years

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Michael J. Mack, MD, discusses his team's seven-year update to the PARTNER 3 trial at TCT 2025 in San Francisco.
PARTNER 3 has been one of the most closely watched clinical trials in cardiology for many years now. Michael J. Mack, MD, presented a seven-year update during a packed session at TCT 2025. 
READ MORE >

Patient sues Abbott after early heart valve replacement

The patient's Trifecta GT heart valve had to be replaced after just six years, an experience he says resulted in "permanent injuries." Abbott pulled the devices off the U.S. market in 2023 due to a known risk of structural valve deterioration. 

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statue justice legal verdict malpractice case lawsuit scale
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Patient sues Abbott after early heart valve replacement

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statue justice legal verdict malpractice case lawsuit scale
The patient's Trifecta GT heart valve had to be replaced after just six years, an experience he says resulted in "permanent injuries." Abbott pulled the devices off the U.S. market in 2023 due to a known risk of structural valve deterioration. 
READ MORE >

Medtronic launches FDA-cleared guidewire compatible with multiple TAVR systems

The guidewire was built specifically with Medtronic's own Evolut platform in mind. However, it is also compatible with all other commercially available TAVR systems.

READ MORE >
Medtronic Stedi Extra Support guidewire
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Medtronic launches FDA-cleared guidewire compatible with multiple TAVR systems

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Medtronic Stedi Extra Support guidewire
The guidewire was built specifically with Medtronic's own Evolut platform in mind. However, it is also compatible with all other commercially available TAVR systems.
READ MORE >

A promising SELUTION: Sirolimus-eluting balloon from Cordis makes impression at TCT 2025

The SELUTION SLR Drug-Eluting Balloon was the topic of two different late-breaking clinical trials at TCT 2025. Both studies found that the device was noninferior to traditional treatments after one year. Long-term data are still needed. 

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Christian M. Spaulding, MD, PhD, at TCT 2025
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A promising SELUTION: Sirolimus-eluting balloon from Cordis makes impression at TCT 2025

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Christian M. Spaulding, MD, PhD, at TCT 2025
The SELUTION SLR Drug-Eluting Balloon was the topic of two different late-breaking clinical trials at TCT 2025. Both studies found that the device was noninferior to traditional treatments after one year. Long-term data are still needed. 
READ MORE >

Cardiology leader, a ’40 under 40’ winner, arrested for leaving baby on beach

Both parents were arrested for neglect and then released the next day after posting a $1,000 bond. The child was unharmed.

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handcuffs arrested arrest jail
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Cardiology leader, a ’40 under 40’ winner, arrested for leaving baby on beach

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handcuffs arrested arrest jail
Both parents were arrested for neglect and then released the next day after posting a $1,000 bond. The child was unharmed.
READ MORE >

FDA clears new AI-enabled coronary plaque analysis software

Circle Cardiovascular Imaging, a Canadian medtech company, received the key approval for its cvi42 | Plaque platform.

READ MORE >
cvi42 | Plaque from Circle Cardiovascular Imaging
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FDA clears new AI-enabled coronary plaque analysis software

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cvi42 | Plaque from Circle Cardiovascular Imaging
Circle Cardiovascular Imaging, a Canadian medtech company, received the key approval for its cvi42 | Plaque platform.
READ MORE >

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