Medtronic has received CE mark approval for several expanded indications for the treatment of coronary artery disease (CAD) with the Prevail paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter, or drug-coated balloon (DCB).
The Prevail DCB now has the broadest range of CE Mark indications including bifurcation and is the only DCB indicated for treatment in patients with multivessel disease, acute coronary syndrome, and diabetes, the company states in a press release.
The CE mark approval follows the release of data from a large, real-world, complex patient population from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) presented as late-breaking clinical research at Cardiovascular Research Technologies (CRT) 2025 (8–11 March, Washington DC, USA). There, it was reported that the Prevail DCB demonstrated low event rates at two years including 6.1% new myocardial infarction, 7.4% target lesion revascularisation, and 0.8% target lesion definite thrombosis. In hybrid percutaneous coronary intervention (defined as DCB and drug-eluting stent in the same vessel), the study showed the Prevail DCB demonstrated numerically lower new myocardial infarction rates versus other DCBs.
These results were confirmed for bifurcation patients in a subgroup analysis presented at EuroPCR (20–23 May, Paris, France). In bifurcation lesions, the Prevail demonstrated low mortality and revascularisation rates, with 2.3% new myocardial infarction, 2.8% target lesion revascularisation, and 0% target lesion definite thrombosis at one year. The event rates were consistently low across the different bifurcation strategies.
“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, senior vice president and president of the Coronary & Renal Denervation business, part of the Cardiovascular Portfolio 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.”
