Medtronic’s Prevail DCB Receives CE Mark for Expanded Indications

May 22, 2025—Medtronic announced that it has received CE Mark approval for several expanded indications for the treatment of coronary artery disease with the company’s Prevail paclitaxel drug-coated balloon (DCB).

According to Medtronic, the Prevail DCB catheter indications now include treatment for bifurcation and for patients with multivessel disease, acute coronary syndrome, and diabetes.

The Prevail DCB was launched in Europe in 2021 with indications for the treatment of de novo lesions, in-stent restenosis, and small vessel disease in the coronary arteries, noted Medtronic.

The company stated that the new CE Mark approval comes after results of the Prevail DCB’s performance in a large, real-world, complex patient population from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). The SCAAR results were presented by Sacharias von Koch, MD, as a late-breaking clinical trial at CRT 25, the Cardiovascular Research Technologies annual meeting held March 8-11 in Washington, DC.

In SCAAR, the Prevail DCB demonstrated low event rates at 2 years including 6.1% new myocardial infarction, 7.4% target lesion revascularization, and 0.8% target lesion definite thrombosis. In hybrid percutaneous coronary intervention (defined as DCB and drug-eluting stent in the same vessel), the Prevail DCB demonstrated numerically lower new myocardial infarction rates versus other DCBs, reported Medtronic.

Medtronic further reported that these results for bifurcation patients were confirmed in a subgroup analysis presented at the EuroPCR 2025 conference held May 20-23 in Paris, France.

In these findings for bifurcation lesions, the Prevail DCB demonstrated low mortality and revascularization rates, with 2.3% new myocardial infarction, 2.8% target lesion revascularization, and 0% target lesion definite thrombosis at 1 year.

The event rates were consistently low across the different bifurcation strategies and suggest the Prevail DCB is an effective treatment option for a variety of complex coronary lesions, stated the company.

The Prevail DCB is commercially available in more than 80 countries globally. It is limited to investigational use in the United States and Japan, advised Medtronic.