Medical Tubing and Extrusion

Medical tubing and extrusion technologies

Pulsed Field Ablation

Boston Scientific reports first cases with next-gen Faraflex catheter

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Boston Scientific today announced the completion of the first-ever cases with its Faraflex mapping and pulsed field ablation (PFA) catheter. This latest technology marks another milestone for the Farapulse PFA portfolio. Boston Scientific initially won FDA approval for Farapulse in January 2024 and has since reported a number of significant … [Read more...] about Boston Scientific reports first cases with next-gen Faraflex catheter

Boston Scientific wins CE mark for Farapulse Nav mapping tech

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Boston Scientific announced today that it received CE mark for its navigation-enabled Farawave Nav ablation catheter and Faraview software. Farawave Nav and the Faraview software make up part of the company’s Farapulse pulsed field ablation (PFA) system. Boston Scientific initially won FDA approval for Farapulse in January 2024. In doing so, it … [Read more...] about Boston Scientific wins CE mark for Farapulse Nav mapping tech

Johnson & Johnson MedTech resumes Varipulse sales after stroke-related pause

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This article originally ran on Feb. 15, 2025. It was updated on Feb. 28 with additional information from the FDA. Johnson & Johnson MedTech announced that it intends to resume the rollout of its Varipulse platform in the U.S. after a temporary pause. Last month, the medtech giant said it temporarily halted all U.S. cases using its … [Read more...] about Johnson & Johnson MedTech resumes Varipulse sales after stroke-related pause

Volta Medical data supports AI-guided ablation for treating AFib

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Volta Medical today announced the publication of data highlighting positive outcomes for its AI-guided ablation procedure. Investigators published findings from the landmark TAILORED-AF clinical trial in Nature Medicine. Data demonstrated that an AI-guided procedure for persistent AFib in combination with conventional pulmonary vein isolation … [Read more...] about Volta Medical data supports AI-guided ablation for treating AFib

Pulse Biosciences is on track for IDE study of PFA tech this year

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Pulse Biosciences (Nasdaq:PLSE) today announced feasibility study data supporting its Nanosecond PFA 360° cardiac catheter system. Along with the data, Paul LaViolette, the company's new CEO and co-chair, said Pulse Biosciences remains on track to begin an FDA investigational device exemption study this year. “[We] look forward to continuing … [Read more...] about Pulse Biosciences is on track for IDE study of PFA tech this year

CardioFocus has positive pulsed field ablation data

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CardioFocus today announced the publication of 12-month data from a study of its pulsed field ablation (PFA) system. ECLIPSE AF, evaluated the safety and performance of the CardioFocus Centauri system with commercial focal ablation catheters. The first-in-human study enrolled 82 patients treated across two centers in Europe. Centauri, which … [Read more...] about CardioFocus has positive pulsed field ablation data

Johnson & Johnson MedTech wins CE mark for dual-energy catheter

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Johnson & Johnson MedTech [WtwhTicker symbol="JNJ"](NYSE: JNJ)[/WtwhTicker] announced today that it received CE mark approval for its dual-energy ThermoCool SmartTouch SF catheter. The irrigated, contact-force sensing catheter features alongside the TruPulse generator. Both offer full integration with the Carto 3 electro-anatomical mapping … [Read more...] about Johnson & Johnson MedTech wins CE mark for dual-energy catheter

Johnson & Johnson MedTech halts Varipulse cases due to stroke reports

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Johnson & Johnson MedTech announced today that it "temporarily paused" all U.S. cases using its Varipulse pulsed field ablation (PFA) system as of Jan. 5. "Out of an abundance of caution, Johnson & Johnson MedTech temporarily paused the U.S. External Evaluation and all U.S. Varipulse cases while we investigate the root cause of four … [Read more...] about Johnson & Johnson MedTech halts Varipulse cases due to stroke reports

Boston Scientific updates instructions for cryoablation catheters after reported deaths

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The FDA issued a notice alerting customers to updates made by Boston Scientific to its PolarX cryoablation catheters. This recall involves updating instructions for use (IFU), not removing devices from the market. The FDA identified it as the most serious type of recall, though, as it may cause serious injury or death. Boston Scientific … [Read more...] about Boston Scientific updates instructions for cryoablation catheters after reported deaths

CardioFocus completes first-in-human pulsed-field ablation case in investigational trial

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CardioFocus announced today that investigators completed the first series of treatments in a study of its OptiShot pulsed-field ablation system. The VISION AF clinical trial evaluates OptiShot as a treatment for paroxysmal AFib. Dr. Vivek Reddy of Mount Sinai and Dr. Petr Neužil of Na Homolce Hospital (Prague) performed the first cases. The … [Read more...] about CardioFocus completes first-in-human pulsed-field ablation case in investigational trial