Following the news that the FDA recently announced that its preliminary review of long-term follow-up data of people with peripheral artery disease being treated by paclitaxel-coated devices, compared with bare devices, revealed a “potentially concerning signal” of increased risk of mortality rates,
Sheryl Tang, Medical Devices analyst at GlobalData offers her view:
“GlobalData estimates that the drug-coated balloons and stents market will grow at a compound annual growth rate (CAGR) of 12% by 2028 due to the rise in peripheral artery disease, significantly better outcomes associated with minimally invasive interventions compared to surgical and pharmaceutical treatment, and reduced risk of restenosis compared to their bare counterparts.
“However, with the recent announcement by the FDA, the growth will likely be impacted and the future potential of drug-coated devices in peripheral interventions is questionable. While no devices have been recalled, there will likely be much more caution surrounding the use of these devices until their long-term safety is confirmed.”