Medical Tubing and Extrusion

Medical tubing and extrusion technologies

Abbott

Abbott imaging catheter recall flagged as Class I by FDA

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The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall. That's the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11. The recall affects … [Read more...] about Abbott imaging catheter recall flagged as Class I by FDA

Abbott announces availability of Xience Skypoint drug-eluting stent in extended sizes

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Abbott (NYSE:ABT) announced today that its Xience Skypoint drug-eluting stent platform is now available globally. Xience Skypoint has received FDA approval, CE mark and PMDA approval in Japan for the broadest expansion with the availability of extended sizes of 4.5 mm and 5 mm offerings. Get the full story at our sister site, Drug Delivery … [Read more...] about Abbott announces availability of Xience Skypoint drug-eluting stent in extended sizes

Study demonstrates freedom from AFib symptoms with use of Abbott’s ablation catheter

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Abbott (NYSE:ABT) announced today that a study showed its TactiCath ablation catheter often led to more than a year of freedom from AFib symptoms. The Persist-End study showed that 89% of patients treated for persistent AFib with the company’s TactiCath contact force ablation catheter, Sensor Enabled (TactiCath SE), remained symptom-free for up … [Read more...] about Study demonstrates freedom from AFib symptoms with use of Abbott’s ablation catheter

Abbott announces U.S. launch of Amplatzer steerable delivery sheath for Amulet device

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Abbott (NYSE:ABT) announced today that it made the Amplatzer steerable delivery sheath commercially available in the U.S. The Amplatzer steerable delivery sheath works with the Amplatzer Amulet left atrial appendage (LAA) occluder to treat people with AFib who are at risk of ischemic stroke According to a news release, the Amulet with … [Read more...] about Abbott announces U.S. launch of Amplatzer steerable delivery sheath for Amulet device

18 of the world’s most innovative medical technologies

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Judges this week are voting for the most innovative medical technologies among the nominees for the 2022 Prix Galien International Awards. The Prix Galien International Awards highlight the most innovative technologies in the life sciences industry. The New York-based Galien Foundation presents the international award to eligible nominees that … [Read more...] about 18 of the world’s most innovative medical technologies

Federal Circuit deals Abbott’s St. Jude Medical a setback in catheter IP case

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A Federal Circuit court ruled that Abbott (NYSE:ABT) subsidiary St. Jude Medical must face patent infringement claims. Just over one year ago, Abbott’s St. Jude — acquired for $25 billion in 2017 — won a patent dispute over the method for using a double catheter in heart failure patients. Get the full story at our sister site, MassDevice. … [Read more...] about Federal Circuit deals Abbott’s St. Jude Medical a setback in catheter IP case

The top 10 catheter innovations of 2021

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Last year was a big year for catheter innovation as medtech companies large and small received regulatory approvals for devices ranging from TAVR to single-use endoscopes. Catheter innovations weren't limited to just adults; Catheter-deployed devices for premature babies and toddlers were also approved and released. And catheter-based devices … [Read more...] about The top 10 catheter innovations of 2021

The top stories from Medical Tubing + Extrusion in 2021

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The medical device industry as a whole experienced a handful of innovations in 2021, but Medical Tubing + Extrusion's reader took a special interest in two catheter-based innovations last year. Here are our most popular articles of 2021:   Links to articles: Cook Medical wins FDA breakthrough device designation for next-gen … [Read more...] about The top stories from Medical Tubing + Extrusion in 2021

Abbott sees the delivery system as a differentiator for its TAVR

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A top Abbott executive explains how the company's FlexNav delivery system could make the Portico TAVR competitive. Abbott is aiming to claw away market share from transcatheter aortic valve replacement pioneers  Edwards Lifesciences and Medtronic. The Abbott Park, Illinois–based medtech company in September announced FDA approval of its Portico … [Read more...] about Abbott sees the delivery system as a differentiator for its TAVR

FDA approves Abbott’s next-gen Epic Plus heart valves

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Abbott (NYSE:ABT) announced today that it received FDA approval for its Epic Plus and Epic Plus Supra stented tissue valves. The approval offers improved therapy options for people with aortic or mitral valve disease through the next-generation devices that build off of Abbott’s Epic surgical valve platform, according to a news release. Get the … [Read more...] about FDA approves Abbott’s next-gen Epic Plus heart valves