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News You Need to Know Today
FDA announces new Class I catheter recalls | Hypertension guidelines embrace early treatment | Palliative care & heart failure
Monday, September 8, 2025
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Editor's Choice: Care Delivery

Update: FDA announces new Class I recalls due to safety issue with Medtronic catheters

More than 100,000 surgical devices are included in these recalls, and there may be "limited product availability" in the months ahead. The FDA first warned the public about this issue in August. 

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the words "FDA recall" on a board
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Update: FDA announces new Class I recalls due to safety issue with Medtronic catheters

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the words "FDA recall" on a board
More than 100,000 surgical devices are included in these recalls, and there may be "limited product availability" in the months ahead. The FDA first warned the public about this issue in August. 
READ MORE >

Johnson & Johnson’s PFA platform is both safe and effective, real-world data confirm

The Varipulse PFA platform, which has already received FDA and CE mark approval, was linked to an adverse event rate of just 0.6%. 

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Biosense Webster, part of Johnson & Johnson MedTech, shared updated data on its Varipulse pulsed field ablation (PFA) system at AF Symposium 2024 in Boston.
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Johnson & Johnson’s PFA platform is both safe and effective, real-world data confirm

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Biosense Webster, part of Johnson & Johnson MedTech, shared updated data on its Varipulse pulsed field ablation (PFA) system at AF Symposium 2024 in Boston.
The Varipulse PFA platform, which has already received FDA and CE mark approval, was linked to an adverse event rate of just 0.6%. 
READ MORE >

New hypertension guidelines embrace early treatment, updated risk assessments and renal denervation

New ACC/AHA recommendations encourage clinicians to take a proactive approach when managing patients with elevated or high blood pressure. The inclusion of renal denervation in this document represents clear progress for a relatively new technology.

READ MORE >
cardiologist doctor physician patient black diverse hypertension
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New hypertension guidelines embrace early treatment, updated risk assessments and renal denervation

Share on Twitter Share on Facebook Share on Linkedin
cardiologist doctor physician patient black diverse hypertension
New ACC/AHA recommendations encourage clinicians to take a proactive approach when managing patients with elevated or high blood pressure. The inclusion of renal denervation in this document represents clear progress for a relatively new technology.
READ MORE >

Philips launches smart telemetry platform for cardiac monitoring

Care teams can face alarm and cognitive overload, with an average of 350 alarms going off per patient per day. But Philips' new telemetry platform streamlines alarm management, delivers data-driven insights and automates clinical tasks—with operational simplicity and networking options.

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Philips introduced a new cardiac monitoring telemetry platform designed to help address critical challenges in healthcare, including staff shortages and alarm management. A key component of the solution is the next-generation Telemetry Monitor 5500 is an integrated central monitoring unit solution that integrates the telemetry device platform.
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Philips launches smart telemetry platform for cardiac monitoring

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Philips introduced a new cardiac monitoring telemetry platform designed to help address critical challenges in healthcare, including staff shortages and alarm management. A key component of the solution is the next-generation Telemetry Monitor 5500 is an integrated central monitoring unit solution that integrates the telemetry device platform.
Care teams can face alarm and cognitive overload, with an average of 350 alarms going off per patient per day. But Philips' new telemetry platform streamlines alarm management, delivers data-driven insights and automates clinical tasks—with operational simplicity and networking options.
READ MORE >

No sedation required: Local anesthesia enough for most TAVR patients

New data out of ESC Congress 2025 suggest care teams can take a more minimalist approach during a majority of TAVR cases and only treat patients with local anesthesia. In some cases, however, sedation will still be necessary. 

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No sedation required: Local anesthesia enough for most TAVR patients

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New data out of ESC Congress 2025 suggest care teams can take a more minimalist approach during a majority of TAVR cases and only treat patients with local anesthesia. In some cases, however, sedation will still be necessary. 
READ MORE >

Palliative care plays an essential role in heart failure care

New HFSA recommendations highlight the importance of integrating palliative care into the day-to-day care of heart failure patients.

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Senior Patient
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Palliative care plays an essential role in heart failure care

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Senior Patient
New HFSA recommendations highlight the importance of integrating palliative care into the day-to-day care of heart failure patients.
READ MORE >

FDA announces new recall of reprocessed EP catheters due to risk of contamination

Customers with these devices on hand are asked to return them right away. No serious injuries have been reported at this time, but the presence of residual particulates can lead to such side effects as pulmonary embolism and deep vein thrombosis.

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Reprocessed Supreme Fixed Electrophysiology Catheter
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FDA announces new recall of reprocessed EP catheters due to risk of contamination

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Reprocessed Supreme Fixed Electrophysiology Catheter
Customers with these devices on hand are asked to return them right away. No serious injuries have been reported at this time, but the presence of residual particulates can lead to such side effects as pulmonary embolism and deep vein thrombosis.
READ MORE >

Pericarditis: New guidance takes on the diagnosis and management of a challenging heart condition

Pericarditis, inflammation of the pericardium, accounts for approximately 5% of all emergency department evaluations for chest pain. These new recommendations are designed to help guide clinicians through the ins and outs of patient care. 

READ MORE >
Pericardial Effusion Sizing Evaluation by Echocardiography. Representative (A) small, (B) moderate, and (C) large PEffs (∗). Representative (D) simple PEff with fibrin strands, (E) exudative PEff, and (F) malignant PEff (∗) caused by pericardial mesothelioma. Adapted with permission from Klein et al. Images and caption courtesy of the American College of Cardiology and JACC.pericarditis cardiac imaging
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Pericarditis: New guidance takes on the diagnosis and management of a challenging heart condition

Share on Twitter Share on Facebook Share on Linkedin
Pericardial Effusion Sizing Evaluation by Echocardiography. Representative (A) small, (B) moderate, and (C) large PEffs (∗). Representative (D) simple PEff with fibrin strands, (E) exudative PEff, and (F) malignant PEff (∗) caused by pericardial mesothelioma. Adapted with permission from Klein et al. Images and caption courtesy of the American College of Cardiology and JACC.pericarditis cardiac imaging
Pericarditis, inflammation of the pericardium, accounts for approximately 5% of all emergency department evaluations for chest pain. These new recommendations are designed to help guide clinicians through the ins and outs of patient care. 
READ MORE >

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