Tag: DES
FDA grants IDE approval for Selution SLR drug-eluting balloon
MedAlliance’s Selution SLR drug-eluting balloon (DEB) has received investigational device exemption (IDE) approval from the Food and Drug Administration, making it the first limus...
Cook Medical receives FDA breakthrough designation for new drug-eluting stent
Cook Medical has received Breakthrough Device designation from the Food and Drug Administration (FDA) on a new drug-eluting stent (DES) for below the knee...
One-year results show ‘superior’ primary patency rate for Eluvia DES compared...
One-year results presented at Vascular Interventional Advances (VIVA) 2021 in Las Vegas (Oct. 5–7) from the EMINENT trial demonstrated the superiority of the Eluvia...
SWEDEPAD unplanned interim analysis shows no difference in all-cause mortality for...
An unplanned interim analysis of the registry-based SWEDEPAD clinical trial, in which patients with peripheral arterial disease (PAD) received treatment with paclitaxel-coated (drug-coated balloons...
Vascular surgeons encouraged to consult talking points document on paclitaxel devices
Vascular surgeons are being encouraged to take consideration of a set of talking points about the risks and benefits of paclitaxel-equipped devices—which has been...
FDA official delivers government agency’s early reaction to latest contentious meta-analysis...
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...
Deploying robust, detailed SVS VQI data to help better define role...
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...
New meta-analysis finds ‘no observed difference’ in mortality between paclitaxel and...
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,...