BfArM, the Ger­man Fed­er­al Insti­tute for Drugs and Med­ical Devices, recent­ly pub­lished a warn­ing notice for patients, users and man­u­fac­tur­ers of stents and bal­loons that are coat­ed with Paclitaxel.

A meta-analy­sis of ran­dom­ized con­trolled tri­als (RCTs) showed that patients treat­ed with these prod­ucts in the femoropopliteal artery of the low­er limbs had a sig­nif­i­cant­ly increased risk of death com­pared to patients who have been treat­ed with uncoat­ed bal­loons or bare met­al stents.

Man­u­fac­tur­ers of these prod­ucts are rec­om­mend­ed to take into account the results of the analy­sis when review­ing the mar­ketabil­i­ty of their devices – in coop­er­a­tion with the Noti­fied Bod­ies. Cor­rec­tive actions should be report­ed to the com­pe­tent authorities.

It is nec­es­sary to gen­er­ate addi­tion­al long-term data. For this pur­pose, fol­low-up with patients of already com­plet­ed RCTs can be resumed. 

Should you require the direct link to the above-men­tioned analy­sis, please let us know.

Source: BfArM