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MHRA: Warning to be added to paclitaxel device IFUs in Europe
In a new field safety notice, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) states that a warning and clinical summary section will be added to the instructions for use (IFU) of 12 paclitaxel-coated balloons and paclitaxel-eluting stents used in…
CX 2020 LIVE pioneers virtual vascular conference format in COVID-19 era
CX 2020 LIVE came to life online—despite COVID-19—using state-of-the art broadcast technology to bring together more than 1,000 vascular specialists, live, from 95 countries across the world. The first session of the highly interactive conference, designed to deliver global vascular education…
FDA official delivers government agency’s early reaction to latest contentious meta-analysis on paclitaxel-coated devices
HOLLYWOOD, Fla.—A Food and Drug Administration (FDA) official delivered a talk which represents the government agency’s earliest public reaction to the latest meta-analysis suggesting significantly reduced amputation-free survival at one year when paclitaxel-coated balloons are applied in arteries below the…
Deploying robust, detailed SVS VQI data to help better define role of paclitaxel technology in clinical practice
In December 2018, the Journal of the American Heart Association published “Risk of death following application of paclitaxel‐coated balloons and stents in the femoropopliteal artery of the leg: A systematic review and meta‐analysis of randomized controlled trials” by Konstantinos Katsanos…
New meta-analysis finds ‘no observed difference’ in mortality between paclitaxel and uncoated device use in CLTI patients
February 2020 brings another paclitaxel device meta-analysis of randomized controlled trials in chronic limb-threatening ischemia (CLTI) patients. Krystal Dinh, BMed, of Westmead Hospital, Sydney, Australia, et al report online ahead of print that the risk of all-cause mortality after treatment with…
SVS president presents point-by-point defense of Society position on paclitaxel controversy
NEW YORK—Kim Hodgson, MD, president of the Society for Vascular Surgery, delivered a robust defense of the SVS position on the drug-coated balloon (DCB) and drug-eluting stent (DES) issue that is currently enveloping the vascular community during the 2019 iteration…
Hotly-contested meta-analysis suggests a higher risk of death or amputation at one year when paclitaxel-coated balloons are used in infrapopliteal arteries
A new meta-analysis, just published in the Journal of Vascular and Interventional Radiology (JVIR), suggests significantly reduced amputation-free survival at one year when paclitaxel-coated balloons are applied in arteries below the knee for critical limb-threatening ischemia (CLTI) treatment, but some…