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News You Need to Know Today
PFA catheters recalled | Surgeons make history | Request for an American Board of Cardiovascular Medicine denied | CCTA adoption
Monday, March 3, 2025
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Today's News and Trends

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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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. 
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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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Featured Articles

FDA sued over ‘reckless and arbitrary’ semaglutide decision

The Outsourcing Facilities Association, a Texas-based trade group, is alleging that supply issues still remain for Ozempic and Wegovy. The group believes the FDA has ignored those issues.

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FDA sued over ‘reckless and arbitrary’ semaglutide decision

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The Outsourcing Facilities Association, a Texas-based trade group, is alleging that supply issues still remain for Ozempic and Wegovy. The group believes the FDA has ignored those issues.
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Teleflex to acquire Biotronik’s vascular intervention business for $791M, split into 2 separate entities

The acquisition helps Teleflex expand its interventional and vascular portfolios. Biotronik, meanwhile, is shifting its focus toward implantable devices and digital healthcare. 

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Business newspaper
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Teleflex to acquire Biotronik’s vascular intervention business for $791M, split into 2 separate entities

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Business newspaper
The acquisition helps Teleflex expand its interventional and vascular portfolios. Biotronik, meanwhile, is shifting its focus toward implantable devices and digital healthcare. 
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Popular TAVR valves linked to comparable long-term outcomes

Second-generation TAVR valves from Medtronic, Edwards Lifesciences and Boston Scientific are all associated with similar seven-year outcomes, according to a new retrospective study out of Italy. 

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The Medtronic CoreValve Evolut and the Edwards Lifesciences Sapien 3 TAVR valves.
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Popular TAVR valves linked to comparable long-term outcomes

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The Medtronic CoreValve Evolut and the Edwards Lifesciences Sapien 3 TAVR valves.
Second-generation TAVR valves from Medtronic, Edwards Lifesciences and Boston Scientific are all associated with similar seven-year outcomes, according to a new retrospective study out of Italy. 
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FDA clears Google smartwatch tech that calls 911 when a user’s heart stops

Google worked with AI specialists, cardiologists and even stunt performers to develop its new smartwatch feature.

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Google has received U.S. Food and Drug Administration (FDA) for Loss of Pulse Detection, a new smartwatch feature that detects when a person’s heart stops beating and then automatically alerts emergency services. Good Pixel Smartwatch Loss of Pulse.
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FDA clears Google smartwatch tech that calls 911 when a user’s heart stops

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Google has received U.S. Food and Drug Administration (FDA) for Loss of Pulse Detection, a new smartwatch feature that detects when a person’s heart stops beating and then automatically alerts emergency services. Good Pixel Smartwatch Loss of Pulse.
Google worked with AI specialists, cardiologists and even stunt performers to develop its new smartwatch feature.
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In Case You Missed It

Cardiologists recommend AVR for asymptomatic severe AS—TAVR and surgery both viable options

A trio of leading voices in cardiology reviewed years of data while considering their proposal. The choice between TAVR and SAVR, they added, should be made on a case-by-case basis.

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Heart cardiologists doctors surgery
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Cardiologists recommend AVR for asymptomatic severe AS—TAVR and surgery both viable options

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Heart cardiologists doctors surgery
A trio of leading voices in cardiology reviewed years of data while considering their proposal. The choice between TAVR and SAVR, they added, should be made on a case-by-case basis.
READ MORE >

Johnson & Johnson MedTech launches new large-bore catheter system for stroke

The next-generation catheter was designed to help clinicians restore blood flow safely and effectively after patients have experienced an acute ischemic stroke. 

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Johnson & Johnson MedTech has launched a new next-generation catheter to be used when treating acute ischemic stroke patients. The Cereglide 92 Catheter System includes a 0.92” catheter as well as the company’s Innerglide 9 deliver aid.
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Johnson & Johnson MedTech launches new large-bore catheter system for stroke

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Johnson & Johnson MedTech has launched a new next-generation catheter to be used when treating acute ischemic stroke patients. The Cereglide 92 Catheter System includes a 0.92” catheter as well as the company’s Innerglide 9 deliver aid.
The next-generation catheter was designed to help clinicians restore blood flow safely and effectively after patients have experienced an acute ischemic stroke. 
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HeartBeam raising $10M for FDA-cleared health tech with public offering

The FDA recently cleared the company's cable-free, credit card-sized heart monitor that produces 12-lead ECGs.

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HeartBeam raising $10M for FDA-cleared health tech with public offering

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The FDA recently cleared the company's cable-free, credit card-sized heart monitor that produces 12-lead ECGs.
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In Other News

Injuries trigger recall related to tables used during image-guided procedures

Users have identified risks related to patients falling from the Philips furniture products during transfer or position changes, the FDA said Friday. 

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Recall | Product recall
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Injuries trigger recall related to tables used during image-guided procedures

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Recall | Product recall
Users have identified risks related to patients falling from the Philips furniture products during transfer or position changes, the FDA said Friday. 
READ MORE >

Healthcare AI newswatch: Surgical symphonies, integrated intelligence, generalist AI, more

The surgeon is only one member of a team in the OR. 

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Artificial intelligence AI in healthcare
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Healthcare AI newswatch: Surgical symphonies, integrated intelligence, generalist AI, more

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Artificial intelligence AI in healthcare
The surgeon is only one member of a team in the OR. 
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