Medtronic announced today that it received CE mark for several expanded indications for its Prevail balloon catheter.
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.
Medtronic also shared results for Prevail in bifurcation patients at EuroPCR 2025 in Paris this week.
Prevail currently has availability in more than 80 countries, including across Europe, where it launched in 2021. The medtech giant won FDA investigational device exemption (IDE) picked up in October 2024. Medtronic announced the first enrolled patient in the Prevail Global study to support U.S. and Japanese approval in February 2025.
More about the performance of the Medtronic Prevail DCB
Medtronic said that, in bifurcation lesions, Prevail demonstrated low mortality and revascularization rates. At one year, investigators reported 2.3% new myocardial infarction, 2.8% target lesion revascularization and 0% target lesion definite thrombosis.
Event rates proved consistently low across the different bifurcation strategies. According to Medtronic, findings suggest Prevail is an effective treatment option for a variety of complex coronary lesions.
Prevail provides superior deliverability, an effective antirestenotic drug formulation (paclitaxel), and sustainable long-term outcomes, Medtronic says. It features a differentiated FreePac coating with an extensive body of evidence in both coronary and peripheral artery disease.
“The Prevail DCB’s acute performance, clinical data, and expanded indications support the needs of physicians who treat increasingly complex patients. We are taking the same approach we’ve taken over the years with our drug-eluting stents,” said Jason Weidman, SVP and president of the Coronary & Renal Denervation business at Medtronic. “By bringing real world clinical data to the forefront, we can expand use of the Prevail DCB in new patient populations. We look forward to helping even more physicians across the globe access the tools they need to give their patients best-in-class care.”
