Treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents

16.04.2019

Affected products
Paclitaxel-coated balloons and paclitaxel-eluting stents

Manufacturers
All manufacturers of paclitaxel-coated balloons and paclitaxel-eluting stents

Reason for publication
On 15 March 2019, the FDA (US Food & Drug Administration) published updated information on the potentially increased mortality associated with the treatment of femoropopliteal lesions with paclitaxel-coated balloons and paclitaxel-eluting stents: Link

This publication is based on a meta-analysis of randomised studies published in the Journal of the American Heart Association: Meta-analysis

The FDA subsequently analysed long-term data from various clinical trials and identified a possible signal of increased long-term mortality in study subjects treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared to study subjects treated with uncoated medical devices. The FDA did point out, however, that the data should be interpreted with caution.

As a result of this meta-analysis the UK-based MHRA (Medicines & Healthcare products Regulatory Agency) has set up an expert group in order to analyse the available data on these medical devices. Expert Advisory Group

Moreover, certain parties have questioned the statistical analysis of the data: Reply of the German Society for Angiology to a question from BfArM

The above-mentioned meta-analysis and its results have also been discussed at the monthly European Vigilance teleconference.

Swissmedic's recommendations
All the information available to Swissmedic calling the device safety into question will be analysed. Swissmedic has hitherto been collecting data on this problem and discussing it with partner authorities in the European context in order to evaluate the significance of these results.

Since the devices available on the market possess valid CE certificates they can remain on the Swiss market. The result of the various ongoing analyses will determine whether recommendations or other regulatory actions will be needed.

Note for patients
If you have health concerns connected with your treatment or your implants, please consult a healthcare professional.

Note for professional users
Doctors must discuss all risks associated with paclitaxel-coated balloons and paclitaxel-eluting stents for the treatment of femoropopliteal lesions with their patients before surgery so that they can then make an informed decision that is appropriate for their individual situation.

All serious incidents connected with paclitaxel-coated balloons and paclitaxel-eluting stents must be reported to Swissmedic.