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Week in Review: Reprocessed catheters recalled | New payment model almost here | 3-year SMART data | Hypertension drug approved

News You Need to Know Today
Week in Review: Reprocessed catheters recalled | New payment model almost here | 3-year SMART data | Hypertension drug approved
Saturday, May 23, 2026
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This Week’s News

Thousands of reprocessed EP catheters recalled

Stryker Sustainability Solutions is recalling more than 8,000 reprocessed medical devices. This is a Class II recall, according to the FDA, and these devices should no longer be used to treat patients.

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Physician warning
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Thousands of reprocessed EP catheters recalled

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Physician warning
Stryker Sustainability Solutions is recalling more than 8,000 reprocessed medical devices. This is a Class II recall, according to the FDA, and these devices should no longer be used to treat patients.
READ MORE >

Cardiologists scramble to prepare for mandatory heart failure payment model

Samuel Jones, MD, reviews some of the biggest concerns about a new Medicare payment model focused on heart failure care that goes live in 2027. 

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Samuel Jones, MD, MPH, director of inpatient electrophysiology at the Memorial Hospital, Chattanooga Heart Institute, discusses concerns over new heart failure Medicare Ambulatory Specialty Model payment model that starts on Jan. 1, 2027.
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Cardiologists scramble to prepare for mandatory heart failure payment model

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Samuel Jones, MD, MPH, director of inpatient electrophysiology at the Memorial Hospital, Chattanooga Heart Institute, discusses concerns over new heart failure Medicare Ambulatory Specialty Model payment model that starts on Jan. 1, 2027.
Samuel Jones, MD, reviews some of the biggest concerns about a new Medicare payment model focused on heart failure care that goes live in 2027. 
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SMART update: Self-expanding TAVR valves still linked to superior durability after 3 years

These three-year data represent a major update to one of the more noteworthy TAVR trials in recent memory.

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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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SMART update: Self-expanding TAVR valves still linked to superior durability after 3 years

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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.
These three-year data represent a major update to one of the more noteworthy TAVR trials in recent memory.
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FDA approves first-in-class hypertension drug from AstraZeneca

Baxdrostat, sold by AstraZeneca under the brand name Baxfendy, is now approved to treat hypertension in combination with other antihypertensive medications.

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How aldosterone works to treat hypertension.
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FDA approves first-in-class hypertension drug from AstraZeneca

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How aldosterone works to treat hypertension.
Baxdrostat, sold by AstraZeneca under the brand name Baxfendy, is now approved to treat hypertension in combination with other antihypertensive medications.
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Medtronic recalls thousands of surgical devices due to contamination risk

This Class II recall includes more than 18,000 cannulae used during cardiac surgery.

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warning safety alert recall healthcare issue
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Medtronic recalls thousands of surgical devices due to contamination risk

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warning safety alert recall healthcare issue
This Class II recall includes more than 18,000 cannulae used during cardiac surgery.
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Exploring the latest data in PFA and leadless conduction system pacing

Vivek Reddy, MD, spoke to Cardiovascular Business about some of the biggest trends in electrophysiology today.

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Video: Vivek Reddy, MD, Director, Cardiac Arrhythmia Service, The Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology, Icahn School of Medicine at Mount Sinai, explains studies on the latest pulsed field ablation and leadless conduction pacing trials. #PFA #conductionpacing
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Exploring the latest data in PFA and leadless conduction system pacing

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Video: Vivek Reddy, MD, Director, Cardiac Arrhythmia Service, The Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology, Icahn School of Medicine at Mount Sinai, explains studies on the latest pulsed field ablation and leadless conduction pacing trials. #PFA #conductionpacing
Vivek Reddy, MD, spoke to Cardiovascular Business about some of the biggest trends in electrophysiology today.
READ MORE >

More good news for Boston Scientific’s coronary IVL tech

Late-breaking data out of EuroPCR focused on 420 patients treated with Boston Scientific's new coronary IVL catheter. Overall, the device was found to be both safe and effective for patients with severe CAD.

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Boston Scientific’s Seismiq 4CE Coronary IVL Catheter
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More good news for Boston Scientific’s coronary IVL tech

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Boston Scientific’s Seismiq 4CE Coronary IVL Catheter
Late-breaking data out of EuroPCR focused on 420 patients treated with Boston Scientific's new coronary IVL catheter. Overall, the device was found to be both safe and effective for patients with severe CAD.
READ MORE >

PFA has been a game-changer for heart patients—but there are still risks

Devi Nair, MD, reviewed some of the rare complications clinicians are seeing with PFA.

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Devi Nair, MD, director of electrophysiology and research, St. Bernards Medical Center and Arrhythmia Research Group, spoke with Cardiovascular Business at the Heart Rhythm 2026 meeting in the above video interview. She explained both the explosion of PFA use since the first FDA approvals in 2024, and the recently discovered complications of coronary vessel spasm and hemolysis and how newer PFA technology might address this.
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PFA has been a game-changer for heart patients—but there are still risks

Share on Twitter Share on Facebook Share on Linkedin
Devi Nair, MD, director of electrophysiology and research, St. Bernards Medical Center and Arrhythmia Research Group, spoke with Cardiovascular Business at the Heart Rhythm 2026 meeting in the above video interview. She explained both the explosion of PFA use since the first FDA approvals in 2024, and the recently discovered complications of coronary vessel spasm and hemolysis and how newer PFA technology might address this.
Devi Nair, MD, reviewed some of the rare complications clinicians are seeing with PFA.
READ MORE >

Boston Scientific invests $1.5B in MiRus with option to buy its TAVR business

Boston Scientific has invested heavily in Georgia-based MiRus, a rising name in the competitive TAVR landscape.

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money business cash flow dollar. Kingsway Financial Services, a Chicago-based holding company with subsidiaries in several industries, has acquired New Jersey-based Digital Diagnostics Imaging (DDI) for $11 million. The transaction was funded with $5.4 million in cash and $5.6 million in debt financing.
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Boston Scientific invests $1.5B in MiRus with option to buy its TAVR business

Share on Twitter Share on Facebook Share on Linkedin
money business cash flow dollar. Kingsway Financial Services, a Chicago-based holding company with subsidiaries in several industries, has acquired New Jersey-based Digital Diagnostics Imaging (DDI) for $11 million. The transaction was funded with $5.4 million in cash and $5.6 million in debt financing.
Boston Scientific has invested heavily in Georgia-based MiRus, a rising name in the competitive TAVR landscape.
READ MORE >

FDA warns public about Johnson & Johnson heart pump controllers after patient death

The FDA has identified another safety concern with Johnson & Johnson MedTech's Automated Impella Controllers. This comes after the devices were linked to five separate recalls in 2025. 

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The FDA has identified another safety concern with Johnson & Johnson MedTech's Automated Impella Controllers. This comes after the devices were linked to five separate recalls in 2025.
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FDA warns public about Johnson & Johnson heart pump controllers after patient death

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The FDA has identified another safety concern with Johnson & Johnson MedTech's Automated Impella Controllers. This comes after the devices were linked to five separate recalls in 2025.
The FDA has identified another safety concern with Johnson & Johnson MedTech's Automated Impella Controllers. This comes after the devices were linked to five separate recalls in 2025. 
READ MORE >

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