Medtronic's Prevail Drug-Coated Balloon Receives Expanded CE Mark for Broadest Indications in Coronary Artery Disease

Medtronic announced itsDrug-Coated BalloonPrevailMultiple extended indications for the treatment of coronary artery disease (CAD) have received CE approval. This allowsPrevailTo become the globally certified CE mark with the widest range of indications (covering bifurcation lesions)Drug-coated balloon, and it is the only one approved for treating multi-vessel disease, acute coronary syndrome, and diabetic patients.Drug-coated balloon.

The reason for this CE expansionPrevailIndications are based onPrevail in a SwedishLargeReal-world complex patient population study.Research showsPrevailCompared with other DCB products, it hasBetter treatment outcomes. For specific research data, see "Prevail: Medtronic Outperforms Biotronik, Bard, and Other Drug-Coated Balloons | Real-World Study of Nearly 2000 Cases”。

Executive Evaluation

"The immediate surgical outcomes, clinical evidence, and expanded indications of Prevail fully meet the needs of clinicians in addressing increasingly complex patient cases. Building on our successful experience in the drug-eluting stent field, we are focusing on real-world clinical evidence to extend the benefits of Prevail to a broader patient population. We look forward to enabling more clinicians worldwide to access this innovative tool, providing exceptional care to patients."

---Jason Weidman  President of Medtronic Cardiovascular Business, Coronary and Renal Denervation Division

Medtronic's Subgroup Analysis Presented at EuroPCR 2025 Further Validates the Efficacy of This Product in Bifurcation Lesions. For patients with bifurcation lesions,PrevailOne-year follow-up data shows:The incidence rates of new myocardial infarction, target lesion revascularization, and definite thrombosis at the target lesion were 2.3%, 2.8%, and 0%, respectively, with consistently low event rates across different bifurcation treatment strategies.。

CurrentlyPrevailAlready inLaunched in more than 80 countries worldwide,The Prevail Global Study, for which the FDA approved an IDE study in 2024, has been initiated.

PrevailAdopted PowerTrac technology, makingPrevailPossessIn Pact AdminTwice the pushing force, thereforePrevailWith betterDelivery Capability,Thereby enabling better control of the curved anatomical structure。

Medtronic, founded in 1949 and headquartered in Minneapolis, Minnesota, USA, is a global leader in medical technology, dedicated to providing lifelong treatment solutions for patients with chronic diseases. Medtronic's main products cover areas such as arrhythmia, heart failure, vascular diseases, heart valve replacement, extracorporeal heart support, minimally invasive cardiac surgery, malignant and non-malignant pain, movement disorders, diabetes, gastrointestinal diseases, urological diseases, spinal disorders, neurological diseases, and ENT surgical treatments.