Affected products
Paclitaxel-coated balloons and paclitaxel-eluting stents
Manufacturer
All manufacturers of paclitaxel-coated balloons and paclitaxel-eluting stents
Background
On 16 April 2019, 8 July 2019 and 24 June 2020, Swissmedic published information for the treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents:
Some manufacturers of paclitaxel-coated balloons and paclitaxel-eluting stents modified the instructions for use of their devices in Europe to provide information regarding the potential risk of increased long-term mortality. The product-specific clinical data was also made available in the instructions for use.
The FDA (US Food & Drug Administration) analysed all available data for the period between 2019 and 2023. This analysis did not confirm the previously suspected potential link between the use of these products and increased long-term mortality (Update FDA). Experts at the MHRA (UK Medicines and Healthcare products Regulatory Agency) came to the same conclusion (Update MHRA).
Measures by Swissmedic
Swissmedic is continuing to gather data on this subject. The Agency will also monitor the performance and safety of these products in the future and inform the public of any new recommendations.
Note for patients
If you have any health concerns connected with your treatment or 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 the latter can then make an informed decision that is appropriate for their individual situation. Furthermore, the findings and recommendations of the FDA should be taken into consideration.
Paclitaxel-Coated Balloons and Stents for Peripheral Arterial Disease
All serious incidents connected with paclitaxel-coated balloons and paclitaxel-eluting stents must be reported to Swissmedic:
Swissmedic, Swiss Agency for Therapeutic Products
Medical Devices Vigilance Department
Hallerstrasse 7
3012 Bern
Tel.: +41 58 462 02 23
Fax: +41 58 462 76 46
Internet: www.swissmedic.ch/md
