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cook medical

Cook Medical wins FDA breakthrough designation for new drug-eluting stent

January 25, 2022 By Danielle Kirsh

Cook Medical - updated logo

Cook Medical recently announced that it received FDA breakthrough designation for its drug-eluting stent for below the knee. Bloomington, Indiana-based Cook Medical designed the stent to treat patients who have chronic limb-threatening ischemia (CLTI). Get the full story on our sister site, Medical Tubing + Extrusion.

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Vascular Tagged With: cook medical

Medtech manufacturers must add warning label to drug-eluting PAD devices

June 16, 2020 By Nancy Crotti

UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Regulatory/Compliance, Vascular Tagged With: B. Braun Medical, Biosensors International, Biotronik, Boston Scientific, cook medical, FDA, Lutonix, LVD Biotech, Medtronic, Spectranetics, UK Medicines and Healthcare products Regulatory Agency

Cook Regentec launches blood filtration trial for critical limb ischemia

September 11, 2019 By Nancy Crotti

Cook Medical - updated logo

Cook Medical’s Regentec division today announced the launch of a clinical trial to evaluate its HemaTrate blood filtration system to treat patients with critical limb ischemia (CLI) due to peripheral arterial disease (PAD). Indianapolis-based Cook Regentec said the HemaTrate system is designed to produce an autologous, peripheral blood-derived total nucleated cell (TNC) concentrate for intramuscular […]

Filed Under: Clinical Trials, Featured, Research & Development, Uncategorized, Vascular Tagged With: cook medical, Cook Regentec

Cook Medical touts paclitaxel-coated stent PAD study results

September 10, 2019 By Nancy Crotti

Cook Medical - updated logo

Cook Medical today touted five-year data from a study into the use of its Zilver PTX paclitaxel-coated stent for peripheral arterial disease (PAD). The study concluded that there was no increase in long-term all-cause mortality due to paclitaxel after treatment using the Zilver PTX stent compared to traditional angioplasty or a bare-metal stent, according to a […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Stents, Uncategorized Tagged With: cook medical, FDA

FDA panel wants more, better data on paclitaxel-eluting devices

June 21, 2019 By Brad Perriello

FDA

An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Stents, Vascular Tagged With: Becton Dickinson, Boston Scientific, cook medical, Medtronic, Peripheral Artery Disease, Royal Philips

FDA: More data needed on paclitaxel devices

June 19, 2019 By Brad Perriello

FDA

More data is needed on devices that elute the drug paclitaxel to determine if they pose a higher mortality risk than non-eluting devices in treating peripheral artery disease, the FDA said ahead of an advisory panel meeting today. A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated balloons […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Vascular, Wall Street Beat Tagged With: Becton Dickinson, Boston Scientific, cook medical, Medtronic, Peripheral Artery Disease, Philips

Cook Regentec launches ProFusion therapeutic infusion needle

March 27, 2019 By Fink Densford

Cook Medical - updated logo

Cook Medical‘s Regentec division said today that it launched the ProFusion therapeutic infusion needle designed for the intramuscular or subdermal infusion of therapeutic agents in the U.S. and Canada. The Indianapolis-based business said that the ProFusion Therapeutic Infusion Needle features multiple sideports arranged in a spiral to aid in the uniform delivery and dispersement of […]

Filed Under: Business/Financial News Tagged With: cook medical

Late mortality rates ‘inadvertently reversed’ in 5-year study of paclitaxel-eluting stent

February 21, 2019 By Sarah Faulkner

Cook Medical - updated logo

The journal Circulation said this week that the all-cause mortality rates in a study comparing a paclitaxel stent and percutaneous transluminal angioplasty in people with peripheral artery disease were “inadvertently reversed” by the authors. In the first version of the paper, originally published in 2016, researchers reported that the 5-year all-cause mortality rate for people […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular Tagged With: Boston Scientific, cook medical, Medtronic

Cook Medical wins FDA nod for 5mm Zilver PTX stent

September 24, 2018 By Brad Perriello

Cook Medical's Zilver PTX 5mm

Cook Medical said it won FDA approval for a smaller-diameter version of its Zilver PTX peripheral drug-eluting stent. Bloomington, Ind.-based Cook said the approval for the 5mm diameter Zilver PTX makes it the first such stent up to 140mm that’s approved in the U.S. for vessels as small as 4mm. “We spend a lot of time […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Vascular Tagged With: cook medical, Peripheral Artery Disease

TCT 2018: Boston Scientific wins FDA nod for drug-eluting vascular stent

September 24, 2018 By Sarah Faulkner

Boston Scientific

On the heels of positive study results at the 30th Transcatheter Cardiovascular Therapeutics meeting, Boston Scientific (NYSE:BSX) won FDA approval for its drug-eluting vascular stent system, Eluvia. The device, which is designed for the treatment of peripheral artery disease, uses a drug-polymer combination to deliver paclitaxel over the course of a year. “Over the past decade, we’ve […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Vascular, Wall Street Beat Tagged With: abbott, biosensors, Biotronik, Boston Scientific, cook medical, Medtronic, TCT 2018

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