The expanded indications for the paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter (or drug-coated balloon/DCB) cover the treatment of coronary artery disease (CAD). According to the medtech giant, Prevail now has the broadest range of CE mark indications, including bifurcation.
Medtronic says the expanded label makes Prevail the only DCB indicated for treatment in patients with multivessel disease, acute coronary syndrome and diabetes.
CE mark comes on the heels of strong performance from Prevail in a large, real-world, complex patient population. The company shared findings from the trial in March. Findings suggested that Prevail is an effective treatment for a variety of complex coronary lesions.