Sterilization plant closures: Here’s why you need to care

(Image by Jose Fontano on Unsplash)

The recent shutdown of a Sterigenics medical device sterilization plant in Willowbrook, Ill. has affected medtech giants such as Becton Dickinson (NYSE:BDX), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Smith & Nephew (NYSE:SNN) and Stryker (NYSE:SYK), according to an FDA list of devices processed at the sterilization plant.

Medium-sized and smaller firms, including Teleflex Medical (NYSE:TFX), Arthrex and ArthroCare also had devices processed there. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, knives, stents and needles. With a Viant sterilization plant in Grand Rapids, Mich. slated to close later this year, the FDA is warning of spot shortages, and smaller medtech companies may be the hardest hit.

Get the full story on our sister site, Medical Design & Outsourcing.

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Medtronic wins expanded FDA indication for Resolute DES

Medtronic logo updated

Medtronic (NYSE:MDT) said today that it won expanded FDA approval for its Resolute drug-eluting stent platform, now cleared for treating patients with coronary artery disease and de novo chronic total occlusion.

The new clearance covers the Resolute Onyx and Resolute Integrity devices, the Fridley, Minn.-based company said.

Read the whole story on our sister site, Drug Delivery Business News

The post Medtronic wins expanded FDA indication for Resolute DES appeared first on MassDevice.

Biotronik wins FDA nod for Orsiro DES

Biotronik logo

Biotronik said today that it won FDA approval for its for its Orsiro drug-eluting stent, touting it as the first and only ultrathin DES to outperform Abbott‘s (NYSE:ABT) Xience.

The Berlin, Germany-based company said that the approval came based on data from the BIOFLOW-V pivotal trial of the device. Results from the study indicated a significantly lower rate for target lesion failure and target vessel myocardial infarction at 12 months as compared to Xience in a large, complex patient audience.

Read the whole story on our sister site, Drug Delivery Business News

The post Biotronik wins FDA nod for Orsiro DES appeared first on MassDevice.

Investigators hit pause on trials following concerns over paclitaxel-coated devices

American Heart Associationmeta-analysis published in the Journal of the American Heart Association last week suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared to people treated with uncoated balloons.

The results of the study prompted investigators for two trials to stop their studies. Meanwhile, leaders in the endovascular community have promised to hold a special forum to discuss the study’s findings.

Get the full story at our sister site, Drug Delivery Business News.

The post Investigators hit pause on trials following concerns over paclitaxel-coated devices appeared first on MassDevice.

Boston Scientific CEO talks pricing pressure for drug-eluting stents

Boston ScientificOn an earnings call with analysts this week, Boston Scientific (NYSE:BSX) CEO Mike Mahoney touted the momentum of his company’s drug-eluting stent portfolio but noted that the technologies continue to face headwinds in the U.S. thanks to pricing pressure.

The Mass.-based company reported third-quarter profits of $432 million, or 31¢ per share, on sales of $2.39 billion for the three months ended Sept. 30, for a bottom-line gain of 52.7% on sales growth of 7.7% compared with Q3 2017.

Get the full story at our sister site, Drug Delivery Business News.

The post Boston Scientific CEO talks pricing pressure for drug-eluting stents appeared first on MassDevice.

EuroPCR 2018: Study compares drug-coated balloons in patients with arterial in-stent restenosis

At this year’s annual EuroPCR meeting, Boston Scientific (NYSE:BSXtouted results from the first trial to compare two drug-coated balloons with different drug formulations – Boston Scientific’s Agent paclitaxel-coated PTCA device and B. Braun’s SeQuent Please balloon.

The 125-patient study evaluated the balloons in patients with in-stent restenosis of a lesion previously treated with a drug-eluting stent or drug-coated balloon.

Get the full story at our sister site, Drug Delivery Business News.

The post EuroPCR 2018: Study compares drug-coated balloons in patients with arterial in-stent restenosis appeared first on MassDevice.

Price caps to keep Abbott’s Xience Sierra off the Indian market

  • 7 medtech stories we missed this week: Nov. 3, 2017

    From Hologic’s new product launch to CapsoVision gettting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Hologic launches new MyoSure device Hologic announced in a Nov. 1 press release that it has launched its MyoSure Manual Device in the U.S. The device is designed […]

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  • TCT 2017: OrbusNeich’s dual therapy stent non-inferior to Abbott’s Xience DES in 1-year follow-up

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    OrbusNeichOrbusNeich touted results today from a pivotal registration study comparing its Combo dual therapy stent with Abbott‘s (NYSE:ABT) Xience stent in patients with ischemic heart disease.

    The trial is designed to evaluate the effectiveness of OrbusNeich’s combined endothelial progenitor cell capture and drug-eluting stent. The data showed that the device is non-inferior to Abbott’s drug-eluting stent after 12 months, with a 7% rate of target vessel failure in the Combo group and 4.2% in the Xience group.

    Get the full story at our sister site, Drug Delivery Business News.

    Elixir Medical unveils ‘bioadaptive’ metallic drug-eluting stent at TCT 2017

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    Elixir Medical DynamXInterventional cardiologists have used stents to keep the heart’s coronary arteries open for decades. Transitioning from bare-metal stents to drug-eluting stents in the early 2000s brought tremendous benefits for patients.

    “But over the last 10 years, the technological progress and meaningful clinical improvements have plateaued,” Elixir Medical CEO Motasim Sirhan told Drug Delivery Business News.

    “When you stent an artery today, you actually cage it and by caging it you are inhibiting the normal pulsatility of the artery and inhibiting its built-in mechanism of adaptive remodeling intended to slow disease progression and clinical events,” he explained.

    So Sirhan’s 65-person company set out to create a device that has the therapeutic benefit of a drug-eluting stent, but also helps the vessel resume its natural healing process. And last night at the annual Transcatheter Cardiovascular Therapeutics meeting, Elixir Medical unveiled what the company is touting as a new class of drug-eluting stents.

    Get the full story at our sister site, Drug Delivery Business News.