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# Mortality Signal with Paclitaxel-coated Devices
- URL: https://www.fdaweb.com/mortality-signal-with-paclitaxel-coated-devices/
- Published: 2019-06-24T12:00:00.000Z
- Updated: 2026-09-15T01:34:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144407

A 6/19-20 meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee unanimously agreed that data show a mortality signal associated with paclitaxel-coated products (e.g., balloons and stents) used to treat peripheral arterial disease in the femoropopliteal arteries. However, panel members were uncertain as to the signal’s magnitude, “primarily due to the small number of trials with five-years follow-up and high levels of missing data,” the agency said in a [summary of the meeting](https://www.fda.gov/media/128246/download?ref=fdaweb.com).  

The panel meeting was convened after a [safety alert](https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm633614.htm?utm%5Fcampaign=FDA%20MedWatch%20Paclitaxel-Coated%20Balloons%20and%20Paclitaxel-Eluting%20Stents&utm%5Fmedium=email&utm%5Fsource=Eloqua) was issued in March about a preliminary data review identified a potentially concerning signal of increased long-term mortality in study subjects compared to patients treated with uncoated devices. The study examined three trials with five-year follow-up data. The alert cautioned that the data should be interpreted carefully for several reasons. First, FDA said there was “large variability in the risk estimate of mortality due to the limited amount of long-term data. Second, these studies were not originally designed to be pooled, introducing greater uncertainty in the results. Third, the specific cause and mechanism of the increased mortality is unknown.”

Panel members expressed concern about the amount of missing data (i.e., vital status, repeat interventional treatments and additional paclitaxel exposure) which “hindered the interpretation of the analyses,” the summary said. The panel recommended that future trials include mechanisms to reduce missing data to the greatest degree possible. The panel also could not identify patient subgroups that might be at particularly high (or low) mortality risk following treatment with paclitaxel-coated devices. They recommended that future studies include a heterogeneous population to help improve the value of subgroup analyses.

Additionally, the panel unanimously agreed that the short-term benefits of paclitaxel-coated devices continue to outweigh the risks, and that they should not be removed from the market. “All panelists agreed that risks should be communicated to the patient to support an informed choice,” the summary said. The panel also agreed that FDA should continue to approve devices with 12-month clinical data that demonstrate safety and effectiveness, but the agency should strengthen post-approval conditions to “ensure adequate data collection for potential signal detection,” it said.

And, regarding challenges associated with enrolling a new large randomized controlled trial, some panel members “suggested conducting further analysis of currently-available clinical data from randomized controlled trials; modifying ongoing trials to collect additional information to evaluate this signal (e.g., extend follow-up to beyond five years, capturing detailed information for repeat interventions); and initiating a randomized study that could be embedded in high-quality registries,” FDA’s summary said. The panel strongly recommended that industry collaborate and reach agreement with FDA on future study design efforts to evaluate the late mortality signal.