FDA Issues Letter Regarding Safety Concerns With Paclitaxel-Coated Devices

January 17, 2019 – The FDA has issued a letter to healthcare providers that they should monitor patients with a type of peripheral arterial disease (PAD) who have been treated with vascular balloons that were coated with paclitaxel or stents that release paclitaxel in the femoropopliteal artery in the leg. The letter follows a meta-analysis that was recently published in the Journal of the American Heart Association (JAHA; CRD42018099447), which suggested that … (leggi tutto)