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Medical Tubing and Extrusion

Medical tubing and extrusion technologies

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Chris Newmarker

How Abbott created its next-gen RF ablation system

March 25, 2024 By Chris Newmarker

An image of the Abbott TactiFlex RF Ablation Catheter showing the distal end all the way to the handle.

For Abbott, combining two innovations into one AFib-treating system required manufacturing fine-tuning. The project’s R&D director explains. Pulsed field ablation (PFA) has generated a great deal of buzz for its potential to reduce complications in procedures for treating atrial fibrillation (AFib). But even as Abbott is developing its Volt … [Read more...] about How Abbott created its next-gen RF ablation system

Filed Under: Applications, Cardiology, Catheters, Components, Product Development, Research & Development, Technologies & Devices Tagged With: Abbott, radiofrequecy ablation

Medtronic has a serious catheter tubing recall

March 7, 2024 By Chris Newmarker

This is an FDA-provided image of Medtronic Duet EMDS catheters disconnected from luer connectors. Some of the catheters were involved in a Class I level recall in 2024.

The FDA today designated a Medtronic recall of Duet external drainage and monitoring system catheter tubing as Class I, its most serious level. Medtronic Neurosurgery initiated the recall on Jan. 22. According to the FDA, it involves 45,176 devices distributed from May 3, 2021, to Jan. 9, 2024. The model numbers involved are 46913, 46914, 46915, … [Read more...] about Medtronic has a serious catheter tubing recall

Filed Under: Catheters, Connectors, Recalls, Regulatory Tagged With: medtronic

ICU Medical’s Smiths Medical has a major syringe pump recall

February 15, 2024 By Chris Newmarker

This is the logo of ICU Medical.

The FDA this week said it's designated an ICU Medical and Smiths Medical recall of Medfusion syringe pumps as Class I, the agency's most serious level of medical device recall. The recall involves more than 50,000 Medfusion Model 4000 syringe infusion pumps in the U.S. that were distributed from Nov. 16, 2010, to July 28, 2023. The Medfusion … [Read more...] about ICU Medical’s Smiths Medical has a major syringe pump recall

Filed Under: Recalls, Regulatory Tagged With: ICU Medical, Smiths Medical

FastWave Medical kicks off first-in-human study of its IVL tech

January 17, 2024 By Chris Newmarker

This is the logo of FastWave Medical.

FastWave Medical announced the successful completion of enrollment for its first-in-human study of its peripheral intravascular lithotripsy (IVL) system to treat calcified cardiovascular disease. Dr. Miguel Montero-Baker of Houston Methodist Hospital and the Hope Vascular & Podiatry Clinic and Dr. Venkatesh Ramaiah of HonorHealth Vascular … [Read more...] about FastWave Medical kicks off first-in-human study of its IVL tech

Filed Under: Balloons, Catheters Tagged With: FastWave Medical

Reflow Medical wins CE mark for temporary spur stent

January 16, 2024 By Chris Newmarker

This is a Reflow Medical marketing image of the Bare Temporary Spur Stent System.

Reflow Medical announced today that it has received a CE mark in the EU for its Bare Temporary Spur Stent System. The system treats de novo or restenotic lesions in the infrapopliteal arteries, followed by a commercially available drug-coated balloon, to enhance drug absorption. The goal is to provide stent-like results while leaving no metal … [Read more...] about Reflow Medical wins CE mark for temporary spur stent

Filed Under: Stents Tagged With: Reflow Medical

Cook Medical brings Slip-Cath Beacon Tip back to the U.S.

January 11, 2024 By Chris Newmarker

This is a Cook Medical marketing image of the Slip-Cath Beacon Tip hydrophilic selective catheter.

Cook Medical recently announced that its Slip-Cath Beacon Tip hydrophilic selective catheter is once again available in the United States and Canada. This reintroduction follows a collaborative effort with medical professionals to refine the product to meet clinical needs better. The Slip-Cath is designed for vascular and non-vascular … [Read more...] about Cook Medical brings Slip-Cath Beacon Tip back to the U.S.

Filed Under: Catheters, Components Tagged With: Cook Medical

Zeus owners are selling to private equity

December 18, 2023 By Chris Newmarker

This is the logo of medical tubing tech company Zeus.

The EQT X fund will become the owner of medical tubing tech provider Zeus under an agreement announced today. Financial terms of the acquisition were not disclosed. Bloomberg reported that the deal values the company at $3.4 billion, citing "people with knowledge of the matter." The transaction is expected to close in Q1 2024, subject to … [Read more...] about Zeus owners are selling to private equity

Filed Under: Tubing Components Tagged With: EQT Private Equity, zeus, Zeus Inc.

Microbot Medical is a step closer to an FDA IDE submission

December 7, 2023 By Chris Newmarker

This image shows the logo of Microbot Medical.

Microbot Medical today announced the successful completion of its pivotal pre-clinical study of its Liberty endovascular robotic surgical system. The study, performed under good laboratory practice (GLP) and essential for the company's investigational device exemption (IDE) submission, took place under rigorous FDA guidelines. The study involved … [Read more...] about Microbot Medical is a step closer to an FDA IDE submission

Filed Under: Catheters, Tools Tagged With: Microbot Medical

VVT Medical announces first commercial ScleroSafe case in U.S.

November 22, 2023 By Chris Newmarker

This is a VVT Medical marketing image of the ScleroSafe system.

VVT Medical recently announced the successful completion of the first commercial U.S. varicose vein treatment using its ScleroSafe platform. Dr. Steve Elias performed the procedure at the Center for Vein Disease, part of the Englewood Health Network in Englewood, New Jersey. “The Sclerosafe procedure takes less than 30 minutes, requires only … [Read more...] about VVT Medical announces first commercial ScleroSafe case in U.S.

Filed Under: Catheters, Needles and Injections, Product Development Tagged With: VVT Medical

Medtronic pulsed-field ablation system wins CE mark

November 20, 2023 By Chris Newmarker

This is a Medtronic marketing image of the PulseSelect pulsed field ablation system.

Medtronic said today that it's received a CE mark for its PulseSelect pulsed field ablation system. In addition, the medtech giant received European Union approval for its Nitron CryoConsole, which builds upon the legacy of the company's cryo franchise with features to optimize the workflow for cryoballoon ablation. The news of the regulatory … [Read more...] about Medtronic pulsed-field ablation system wins CE mark

Filed Under: Catheters, Product Development, Regulatory Tagged With: Medtroinc, pulsed-field ablation (PFA)

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