Taking a note from the FDA, U.K. and French regulators are investigating the safety of paclitaxel devices for the treatment of peripheral artery disease.
Last week, the U.K. Medicines and Healthcare Products Agency said it ordered an inquiry into the safety of these devices following the publication of a meta-analysis that suggested a heightened risk of late mortality in people treated with paclitaxel devices compared to bare devices.
French regulator Agence Nationale de Sécurité du Médicament et des Produits de Santé has also reportedly called for an investigation, according to BioWorld MedTech.
Earlier this year, the FDA said that it plans to assess long-term follow-up data from studies that supported the approval of paclitaxel-coated balloons or paclitaxel-eluting stents in the U.S. Specifically, the regulatory group is slated to focus on causes of death within these studies, paclitaxel dose delivered and patient characteristics.
Medical device manufacturers have defended the approved indications for their products. But in the wake of the meta-analysis, a number of companies have come forward about mistakes regarding the published data backing their paclitaxel devices in PAD patients.
In February, Medtronic (NYSE:MDT) reported that it inadvertently omitted an undisclosed number of patient deaths from studies of its paclitaxel-coated balloons. Later that month, the journal Circulation said that the all-cause mortality rates in a study comparing a paclitaxel stent and percutaneous transluminal angioplasty in people with peripheral artery disease were “inadvertently reversed” by the authors.
On top of the inquiries from regulators, non-for-profit org Viva Physicians also plans to lead an effort to study the use of paclitaxel devices for the treatment of PAD.