Affected products
Paclitaxel-coated balloons and paclitaxel-eluting stents
Manufacturers
All manufacturers of paclitaxel-coated balloons and paclitaxel-eluting stents
Reason for publication
On 16 April 2019, Swissmedic published initial information for the treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents: Link
Since that date, new findings and recommendations from the FDA (US Food & Drug Administration) and the Expert Advisory Group (EAG), formed by the UK-based MHRA (Medicines & Healthcare products Regulatory Agency), have become available: FDA recommendations, EAG recommendations
Following the recommendations of the EAG, the MHRA published a medical device alert (MDA) with revised recommendations for the treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents: MHRA MDA
Swissmedic's recommendations
All the information available to Swissmedic calling the device safety into question will be analysed. Swissmedic is continuing to gather additional data on this subject.
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. Furthermore, the new findings and recommendations of the FDA and the EAG should be taken into consideration.
All serious incidents connected with paclitaxel-coated balloons and paclitaxel-eluting stents must be reported to Swissmedic.
