Concerning reports about potential mortality rates caused by paclitaxel-coated devices have been raised by the FDA.
FDA approved
In an analysis of randomised clinical trials published in the Journal of the American Heart Association, the FDA found a potential increase in mortality rates after drug-coated devices were used to treat peripheral artery disease.
Paclitaxel-coated balloons and stents are used to improve blood flow to the legs and avoid repeat procedures to reopen blocked blood vessels. Paclitaxel, which is typically used in treatments for cancer, is released from the devices to help prevent scar tissue formation in in the blood vessel.
When reviewing three clinical trials with five-year follow-up data, the FDA found that there was approximately 50% increased risk of mortality for patients treated with paclitaxel-coated devices compared to those treated with bare counterparts.
However, the FDA has warned that these data should be viewed cautiously due to a large amount of variability in mortality estimations and a lack of long-term data. More so, while an increased risk was observed, it’s unknown what the specific cause of mortality was.
The FDA is now urging healthcare institutions to use alternative treatment options for most patients while it further evaluates the increased mortality rates.
Sheryl Tang, medical devices analyst at GlobalData states that the future for for drug-coated balloons and stents is now in question.
“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,” Tang said.