The second day of the advisory hearing on paclitaxel devices for the lower limbs included additional pushback against analyses by the FDA and a medical journal article. However, the panel struggled to isolate a dose-response metric that would have lent credibility to the argument that mortality is higher on these devices. Consequently, the panel recommended longer follow-up in future studies of new devices, and sponsors of existing approvals will have to ratchet up their follow-up efforts. Read More
