UK regulators have set up an independent expert advisory group (EAG) to review the safety of paclitaxel-coated balloons and stents, after recent research raised concerns over an increased risk of death when these devices are used to treat patients with peripheral arterial disease, particularly when implanted in the femoropopliteal artery.
The EAG has begun the process of reviewing the available but highly complex information on these medical devices, the Medicines and Healthcare products Regulatory Agency said. It is expected to...