Medical Tubing and Extrusion

Medical tubing and extrusion technologies

medtronic

Medtronic has a Class I recall involving balloon catheters to treat heart defects

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FDA today designated a Medtronic recall of Rashkind balloon septostomy catheters as Class I, its most serious level. The balloon catheters create an atrial septal defect or to enlarge an existing atrial septal defect in order to treat congenital heart defects. Medtronic (NYSE:MDT) initiated a recall of the Rashkind balloon septostomy … [Read more...] about Medtronic has a Class I recall involving balloon catheters to treat heart defects

FDA approves Medtronic venous stent

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Medtronic this week announced that it received FDA approval for its Abre venous self-expanding stent system. The device is indicated for use in the iliofemoral veins in patients that have symptomatic iliofemoral venous outflow obstruction. "Patients with deep venous obstruction are often younger, therefore it's critical to have a venous stent … [Read more...] about FDA approves Medtronic venous stent

Medtronic Resolute Onyx stent gains expanded FDA clearance

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Medtronic today said it received FDA clearance for an expanded indication of its Resolute Onyx drug-eluting stent (DES). The new indication allows for one-month of dual-antiplatelet therapy (DAPT) labeling with an expanded indication for high bleeding risk patients that are implanted with the device. Resolute Onyx is the only DES in the U.S. … [Read more...] about Medtronic Resolute Onyx stent gains expanded FDA clearance

Medtronic touts cryoablation therapy study results

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Medtronic (NYSE:MDT) touted results demonstrating the superiority of two of its cryoablation therapy technologies. Fridley, Minn.-based Medtronic said in a news release that trials showed the superiority of the Arctic Front advance cardiac cryoballoon and the Freezor max cardiac cryoablation catheter for the first-line treatment (before drug … [Read more...] about Medtronic touts cryoablation therapy study results

Study: Medtronic’s drug-coated balloon reduces dialysis interruptions

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Medtronic (NYSE:MDT) recently announced the results of a study showing that some kidney disease patients who had a drug-coated balloon (DCB) implanted to treat arteriovenous (AV) failure experienced fewer interruptions of dialysis treatment. Many end-stage renal disease (ESRD) patients require AV fistulae in order to receive continuous dialysis. … [Read more...] about Study: Medtronic’s drug-coated balloon reduces dialysis interruptions

Medtronic recalls certain balloon catheters

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Medtronic is voluntarily recalling certain balloon dilation catheters that have proven difficult to remove from patients’ bodies. The recall affects a subset of the company’s Euphora and Solarice semi-compliant rapid exchange balloon dilatation catheters manufactured from February 27, 2019, through July 31, 2019, according to a letter sent to … [Read more...] about Medtronic recalls certain balloon catheters

Innovative Health lands another catheter reprocessing clearance

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Innovative Health said today that it has received FDA clearance to reprocess the Biosense Webster PentaRay Nav eco high-density mapping catheter for reuse. The clearance is the latest allowing Scottsdale, Ariz.-based Innovative Health to reprocess catheters. The FDA cleared it in 2018 to reprocess St. Jude Medical’s Advisor FL, Medtronic’s Torqr … [Read more...] about Innovative Health lands another catheter reprocessing clearance

CMS expands TAVR coverage

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The Centers for Medicare and Medicaid Services have updated the criteria for hospitals and physicians to begin or continue providing transcatheter aortic valve replacement surgery. The decision gives hospitals and providers more flexibility to meet the CMS requirements for performing TAVR, the agency said Friday. The original National Coverage … [Read more...] about CMS expands TAVR coverage

7 innovations that made nurses’ jobs easier

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There are approximately 4 million registered nurses in the U.S., according to the American Nurses Association. As the heart of every hospital, nurses have to handle different patients and situations on a daily basis and are a pivotal part of healthcare settings around the globe. I asked veteran nurses who have taken care of a wide range of … [Read more...] about 7 innovations that made nurses’ jobs easier

How innovative pump designs power intelligent balloon catheters

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The next generation of intelligent balloon catheters depends on novel designs of ball-screw-driven pumps. Bruce Gretz, Steinmeyer Balloon catheters have long seen widespread use in cardiovascular applications. One of the first, decades ago, was intra-aortic. A balloon was implanted into the descending aorta and pressurized via a percutaneous … [Read more...] about How innovative pump designs power intelligent balloon catheters