Boston Scientific Stands Behind Its Stents in Wake of JAHA Article and FDA Investigation

The Journal of the American Heart Association (JAHA) published an article in December saying that paclitaxel-coated balloons and stents manufactured by Boston Scientific and others had an increased risk of death. In a January 17, 2019 letter to health care providers, the U.S. Food and Drug Administration (FDA) indicated it was evaluating available long-term follow-up data to determine if there were any long-term risks associated with the devices, but had drawn no conclusions as of yet.

Boston Scientific is defending their products, indicating it will work with the FDA.