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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 DEB to be available to U.S. patients, the company announced in a press release. The Selution…
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 (BTK). This new stent is designed to treat patients suffering from chronic limb-threatening ischemia (CLTI). The Breakthrough…
One-year results show ‘superior’ primary patency rate for Eluvia DES compared to bare metal stents
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 drug-eluting stent (DES) system (Boston Scientific) compared to self-expanding bare metal stents for the treatment of…
SWEDEPAD unplanned interim analysis shows no difference in all-cause mortality for paclitaxel devices
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 or drug-eluting stents) or uncoated endovascular devices, “did not show a difference between the groups in…
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 developed by a multispecialty panel of medical societies—in discussions with their patients. The document is the…
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…