The Portico self-expanding graft has obtained FDA approval and can now compete as one of the three options available in clinical practice for transcatheter aortic valve replacement (TAVR) in the United States. For the time being, its indication will have some restrictions: for example, it can only be used in high-risk patients (unlike CoreValve and…
The FDA Approves Ticagrelor for Primary Prevention in High Risk Patients
The FDA has approved the indication of ticagrelor as primary prevention in high risk CAD patients with no history of MI or stroke. The lab producing ticagrelor has informed the FDA has based this decision on the THEMIS study, which included nearly 20,000 patients with stable CAD and type 2 diabetes. This decision has come…
FDA Alert on Drug-Coated Balloons and Stents in Femoropopliteal Artery Disease
The US Food and Drug Administration (FDA) has issued an alert on the potential long-term risk of paclitaxel-coated balloons and paclitaxel-eluting stents in patients with femoropopliteal artery disease. This agency is evaluating signals of increased long-term deaths among patients with femoral or popliteal artery disease treated with paclitaxel-coated devices in a recent study. In…