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News You Need to Know Today
FDA approves new PFA system | Watchman data highlight bleeding benefit | Boston Scientific makes a move
Friday, November 29, 2024
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Editor's Choice: Heart Rhythm

Johnson & Johnson MedTech gains FDA approval for Varipulse PFA system

Johnson & Johnson is now the third company with an FDA-approved PFA system in its portfolio, joining Medtronic and Boston Scientific. Varipulse previously gained CE mark approval in February. 

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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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Johnson & Johnson MedTech gains FDA approval for Varipulse PFA system

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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
Johnson & Johnson is now the third company with an FDA-approved PFA system in its portfolio, joining Medtronic and Boston Scientific. Varipulse previously gained CE mark approval in February. 
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LAAC with Watchman FLX reduces bleeding risks after AFib ablation

The new data, presented during AHA Scientific Sessions 2024, suggest LAAC with Boston Scientific's Watchman FLX could be a safe, effective alternative to OAC for limiting post-ablation strokes.

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Left atrial appendage occlusion (LAAO) with the Watchman FLX device from Boston Scientific is associated with positive outcomes and limited adverse events after one year, according to new findings published in Circulation: Cardiovascular Interventions.[1] Many prior Watchman FLX studies, including PINNACLE FLX, had focused on the device’s performance in a controlled setting. The study’s authors hoped to gain a better understanding of its real-world impact by reviewing registry data from more than 97,000 U.S
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LAAC with Watchman FLX reduces bleeding risks after AFib ablation

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Left atrial appendage occlusion (LAAO) with the Watchman FLX device from Boston Scientific is associated with positive outcomes and limited adverse events after one year, according to new findings published in Circulation: Cardiovascular Interventions.[1] Many prior Watchman FLX studies, including PINNACLE FLX, had focused on the device’s performance in a controlled setting. The study’s authors hoped to gain a better understanding of its real-world impact by reviewing registry data from more than 97,000 U.S
The new data, presented during AHA Scientific Sessions 2024, suggest LAAC with Boston Scientific's Watchman FLX could be a safe, effective alternative to OAC for limiting post-ablation strokes.
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Boston Scientific agrees to acquire AFib ablation company

Boston Scientific has scooped up Cortex, a healthcare technology company launched by the venture capital firm Ajax Health in 2023, in a move that will expand its EP offerings.

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merger acquisition M&A business
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Boston Scientific agrees to acquire AFib ablation company

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merger acquisition M&A business
Boston Scientific has scooped up Cortex, a healthcare technology company launched by the venture capital firm Ajax Health in 2023, in a move that will expand its EP offerings.
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Eko Health’s AI platform for digital stethoscopes granted new CPT code

The Sensora platform, which includes multiple FDA-approved algorithms, has a new Category III CPT code.

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eko health digital stethoscope artificial intelligence. The combination of Eko Health’s AI-powered SENSORA platform and its digital stethoscope technology achieved a sensitivity of 94.1% and specificity of 84.5% when it came to identifying valvular heart disease.
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Eko Health’s AI platform for digital stethoscopes granted new CPT code

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eko health digital stethoscope artificial intelligence. The combination of Eko Health’s AI-powered SENSORA platform and its digital stethoscope technology achieved a sensitivity of 94.1% and specificity of 84.5% when it came to identifying valvular heart disease.
The Sensora platform, which includes multiple FDA-approved algorithms, has a new Category III CPT code.
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Predicting sudden cardiac death after a heart attack may be impossible—for now

Researchers tried to crack the code, but they fell short time and time again. AI may offer potential as one way to finally find an answer, they added. 

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Man Heart Attack
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Predicting sudden cardiac death after a heart attack may be impossible—for now

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Man Heart Attack
Researchers tried to crack the code, but they fell short time and time again. AI may offer potential as one way to finally find an answer, they added. 
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Heart Rhythm Society launches new group focused on EP advocacy

The new organization, Heart Rhythm Advocates, will urge federal policymakers to pass legislation and support actions that have a positive impact on the future of electrophysiology.

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Congress
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Heart Rhythm Society launches new group focused on EP advocacy

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Congress
The new organization, Heart Rhythm Advocates, will urge federal policymakers to pass legislation and support actions that have a positive impact on the future of electrophysiology.
READ MORE >

Concomitant ablation surgery during heart operations boosts long-term survival

Treating AFib with surgical ablation during mitral valve surgery and other common heart operations can help patients live longer, a new meta-analysis confirmed.

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According to the U.S. government, Asante Health System and one of its surgeons knowingly submitted false claims to Medicare, Medicaid and TRICARE for more than six years. Heart surgery surgeons.
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Concomitant ablation surgery during heart operations boosts long-term survival

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According to the U.S. government, Asante Health System and one of its surgeons knowingly submitted false claims to Medicare, Medicaid and TRICARE for more than six years. Heart surgery surgeons.
Treating AFib with surgical ablation during mitral valve surgery and other common heart operations can help patients live longer, a new meta-analysis confirmed.
READ MORE >

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