FDA probes paclitaxel-eluting stents, balloons

The FDA wrote a letter to healthcare providers yesterday on the heels of a meta-analysis that suggested an increased mortality rate after two years in people with peripheral artery disease who were treated with paclitaxel-coated and paclitaxel-eluting devices compared to bare devices. The agency is “evaluating” the new information presented by the study and recommended that healthcare providers continue closely watching patients who have been treated with the drug-eluting devices. Get the full story at our sister site, Drug Delivery Business News. The post FDA probes paclitaxel-eluting stents, balloons appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Drug-Device Combinations Featured Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Vascular Wall Street Beat Boston Scientific Medtronic Source Type: news