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Philips pulls medical devices over safety concerns | Boston Scientific enters renal denervation market | New ACS guidelines

News You Need to Know Today
Philips pulls medical devices over safety concerns | Boston Scientific enters renal denervation market | New ACS guidelines
Tuesday, March 4, 2025
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Today's News and Trends

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. 
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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. 
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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. 
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Featured Articles

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.
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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.
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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. 
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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 >

In Case You Missed It

FDA announces new recall of Johnson & Johnson heart pumps over safety concerns

No devices need to be returned at this time. However, the FDA warned, using these heart pumps without reviewing the updated instructions could result in "serious injury or death.” 

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the words "FDA recall" on a board
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FDA announces new recall of Johnson & Johnson heart pumps over safety concerns

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the words "FDA recall" on a board
No devices need to be returned at this time. However, the FDA warned, using these heart pumps without reviewing the updated instructions could result in "serious injury or death.” 
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CABG, TAVR top list of most lucrative heart procedures for hospitals

Other procedures are associated with higher profits—heart transplants, for instance—but CABG and TAVR are performed much more often.

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Money dollar investments
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CABG, TAVR top list of most lucrative heart procedures for hospitals

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Money dollar investments
Other procedures are associated with higher profits—heart transplants, for instance—but CABG and TAVR are performed much more often.
READ MORE >

LAAO or DOAC? Mayo Clinic AI helps guide treatment of AFib patients

It can be challenging to know which AFib patients are the best candidates for LAAO. A new algorithm out of Mayo Clinic aims to address that problem. 

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AI artificial intelligence stethoscope doctor
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LAAO or DOAC? Mayo Clinic AI helps guide treatment of AFib patients

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AI artificial intelligence stethoscope doctor
It can be challenging to know which AFib patients are the best candidates for LAAO. A new algorithm out of Mayo Clinic aims to address that problem. 
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In Other News

New low-field scanner detects cancer spread better than traditional breast MRI

Researchers involved in its development are hopeful that the scanner could eventually lead to improved outcomes in cancer patients who require surgery to remove malignant tissue. 

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Images from traditional breast MRI (left) compared to FCI scanner images (right). Courtesy of University of Aberdeen.
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New low-field scanner detects cancer spread better than traditional breast MRI

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Images from traditional breast MRI (left) compared to FCI scanner images (right). Courtesy of University of Aberdeen.
Researchers involved in its development are hopeful that the scanner could eventually lead to improved outcomes in cancer patients who require surgery to remove malignant tissue. 
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FDA announces recall of endoscope sheaths after 26 injuries

While there have been no reported deaths, certain lots of Olympus single-use guide sheath kits are to be quarantined immediately. 

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the words "FDA recall" on a board
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FDA announces recall of endoscope sheaths after 26 injuries

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the words "FDA recall" on a board
While there have been no reported deaths, certain lots of Olympus single-use guide sheath kits are to be quarantined immediately. 
READ MORE >

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