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Week in Review: PFA catheters recalled | Devices pulled from market | FDA approves stroke drug | New ACS guidelines

News You Need to Know Today
Week in Review: PFA catheters recalled | Devices pulled from market | FDA approves stroke drug | New ACS guidelines
Saturday, March 8, 2025
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This Week’s News

FDA announces catheter recall for Johnson & Johnson PFA system due to stroke risk

The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained.

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The late-breaking U.S. multicenter admIRE clinical trial at the Heart Rhythm Society 2024 meeting, showed positive data on the long-term safety and effectiveness of the the Biosense Webster Varipulse pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation. #HRS #HRS2024 #PFA
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FDA announces catheter recall for Johnson & Johnson PFA system due to stroke risk

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The late-breaking U.S. multicenter admIRE clinical trial at the Heart Rhythm Society 2024 meeting, showed positive data on the long-term safety and effectiveness of the the Biosense Webster Varipulse pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation. #HRS #HRS2024 #PFA
The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained.
READ MORE >

Philips pulls endovascular devices from market after safety issues prompt Class I recall

Philips is recalling all sizes of its Tack Endovascular System after 20 patient injuries were reported. Interventional cardiologists are urged to stop using the device immediately. 

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FDA Recall
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Philips pulls endovascular devices from market after safety issues prompt Class I recall

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FDA Recall
Philips is recalling all sizes of its Tack Endovascular System after 20 patient injuries were reported. Interventional cardiologists are urged to stop using the device immediately. 
READ MORE >

Request for an American Board of Cardiovascular Medicine denied—cardiology groups ‘deeply disappointed’

The ACC, AHA, HFSA, HRS and SCAI all worked together to try and make the new board a reality. Though their proposal has been denied, the groups say they are not done fighting. 

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Cardiologists employed by a hospital appear to be more likely to pursue cardiac catheterization or angioplasty than independent cardiologists. female physician male
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Request for an American Board of Cardiovascular Medicine denied—cardiology groups ‘deeply disappointed’

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Cardiologists employed by a hospital appear to be more likely to pursue cardiac catheterization or angioplasty than independent cardiologists. female physician male
The ACC, AHA, HFSA, HRS and SCAI all worked together to try and make the new board a reality. Though their proposal has been denied, the groups say they are not done fighting. 
READ MORE >

Surgeons make history, perform world’s first living mitral valve replacement

The historic heart procedure was part of a series of operations that saved the lives of three young girls. “The whole situation is extraordinary, whether you look at it from the standpoint of a scientific breakthrough or the average person’s point of view,” one parent said. 

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Douglas Overbey, MD, an assistant professor in the department of surgery at Duke University School of Medicine, checks in with 9-year-old Kensley Frizzell as she recovers from heart surgery. Image courtesy of Duke Health and Duke University School of Medicine.
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Surgeons make history, perform world’s first living mitral valve replacement

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Douglas Overbey, MD, an assistant professor in the department of surgery at Duke University School of Medicine, checks in with 9-year-old Kensley Frizzell as she recovers from heart surgery. Image courtesy of Duke Health and Duke University School of Medicine.
The historic heart procedure was part of a series of operations that saved the lives of three young girls. “The whole situation is extraordinary, whether you look at it from the standpoint of a scientific breakthrough or the average person’s point of view,” one parent said. 
READ MORE >

Cardiologists are first in world to use new TAVR catheter from Boston Scientific

The new Self-Centering Guide Catheter was designed to help care teams with the retrograde crossing of the aortic valve during TAVR. Researchers evaluated the safety and effectiveness of the catheter, sharing their experience in JACC: Cardiovascular Interventions.

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self-centering guide catheter (SCGC) for TAVR from Boston Scientific
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Cardiologists are first in world to use new TAVR catheter from Boston Scientific

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self-centering guide catheter (SCGC) for TAVR from Boston Scientific
The new Self-Centering Guide Catheter was designed to help care teams with the retrograde crossing of the aortic valve during TAVR. Researchers evaluated the safety and effectiveness of the catheter, sharing their experience in JACC: Cardiovascular Interventions.
READ MORE >

FDA approves first new clot-dissolving drug for ischemic stroke in decades

Tenecteplase is a tissue plasminogen activator given to patients through a single five-second intravenous bolus. It is only the second drug of its kind to gain FDA approval, and the first in many years.

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FDA approves first new clot-dissolving drug for ischemic stroke in decades

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Tenecteplase is a tissue plasminogen activator given to patients through a single five-second intravenous bolus. It is only the second drug of its kind to gain FDA approval, and the first in many years.
READ MORE >

Boston Scientific enters renal denervation market with acquisition worth up to $540M

Boston Scientific has announced another significant M&A deal, scooping up an Israeli medtech company focused on RDN technology. 

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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 enters renal denervation market with acquisition worth up to $540M

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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.
Boston Scientific has announced another significant M&A deal, scooping up an Israeli medtech company focused on RDN technology. 
READ MORE >

Why cardiac CT adoption remains low among primary care providers

The rapid rise of CCTA represents one of cardiology’s biggest ongoing trends, but most primary care providers are still not embracing a CT-first strategy.

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patient undergoing CCTA exam
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Why cardiac CT adoption remains low among primary care providers

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patient undergoing CCTA exam
The rapid rise of CCTA represents one of cardiology’s biggest ongoing trends, but most primary care providers are still not embracing a CT-first strategy.
READ MORE >

Cardiologists recommend complete revascularization, intravascular imaging in new ACS guidelines

The American College of Cardiology and American Heart Association published the new guidelines with assistance from other leading U.S. medical societies. 

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American Heart Association and Joint Commission launch new Comprehensive Heart Attack Center certification.
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Cardiologists recommend complete revascularization, intravascular imaging in new ACS guidelines

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American Heart Association and Joint Commission launch new Comprehensive Heart Attack Center certification.
The American College of Cardiology and American Heart Association published the new guidelines with assistance from other leading U.S. medical societies. 
READ MORE >

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