FDA Committee Befuddled by Data Discrepancies on Paclitaxel Devices

After two days of presentations regarding the death risk that may be associated with paclitaxel-coated balloons and paclitaxel-eluting stents on the market and in clinical trials, FDA learned a lot about but the agency still has a lot of work to do before any concrete decisions are made regarding the risk-benefit of the devices in question. How The Paclitaxel Debate Began To recap, paclitaxel balloons and stents received some bad press in late December 2018 after a meta-analysis showed an increased risk of death for patients treated with these devices. After conducting a preliminary analysis of long-term follow-up data (up to five years in some studies) of the pivotal premarket randomized trials for paclitaxel-coated products indicated for PAD, FDA sent a letter to healthcare providers in March, urging physicians to seek alternatives to paclitaxel-coated devices. The agency said its preliminary review of the data identified "a potentially concerning signal of increased long-term mortality" in clinical trial patients treated with these drug-coated devices compared to patients treated with uncoated devices. Of the three trials with five-year follow-up data, each showed higher mortality in the patients treated with paclitaxel-coated products. In total, among the 975 patients in these three trials, there was an approximately 50% increased risk of mortality in subjects treated with paclitaxel-coate...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news