The US Food and Drug Authority (FDA) recently announced that its preliminary review of long-term, follow-up data of people with peripheral artery disease (PAD) being treated with paclitaxel-coated devices compared with bare devices revealed a “potentially concerning signal” of increased risk of mortality.

Peripheral artery disease treatment

Minimally invasive interventions for treating peripheral artery disease are growing as they continue to demonstrate better patient outcomes compared to pharmaceutical treatment and open surgery. The introduction of drug-coated devices in coronary interventions showed superior results compared to their bare counterparts, where there was a reduction in complications, such as myocardial infarction and restenosis, and better revascularisation rates.

Eventually, this led to the development of drug-coated devices in the peripheral vascular interventions market. With the rise of peripheral vascular disease and interventions being performed in clinics to reach a larger patient population, GlobalData estimates the drug-coated balloons and stents market to grow at a compound annual growth rate of 12% worldwide by 2028.

FDA and paclitaxel-coated devices

With the latest announcement by the FDA on recent data showing an increased mortality risk in patients treated with paclitaxel-coated devices for peripheral vascular disease, GlobalData predicts that this will significantly impact the current growth of the market.

The FDA has since issued recommendations on the use of paclitaxel-coated devices and considers these new data as part of the discussion of the risks and benefits. While the benefits may outweigh the risk for some patients, such as those who are at a particularly higher risk for restenosis, growth in the market will likely be impacted due to heightened caution surrounding the use of this device.