Medtronic’s Prevail drug-coated balloon (DCB) has received expanded CE mark approvals for the treatment of coronary artery disease (CAD), now covering patients with multivessel disease, acute coronary syndrome, and diabetes.
The paclitaxel-coated balloon, used during PCI procedures, demonstrated strong two-year clinical outcomes:
- 6.1% new myocardial infarction rate
- 7.4% target lesion revascularization
- 0.8% target lesion definite thrombosis
Positive one-year data in bifurcation lesions was also highlighted at EuroPCR 2025.
Though already approved in many countries, Prevail is still pending FDA approval. A new global trial enrolling 1,205 patients is underway to support that effort, focusing on in-stent restenosis and small vessel disease.
Follow MEDWIRE.AI for the latest in interventional cardiology innovations.
