Medtronic has received CE mark approval for several expanded indications to treat coronary artery disease (CAD) with its Prevail paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter, also known as a drug-coated balloon (DCB).

The EU nod means Prevail DCB now has the broadest range of CE mark indications including bifurcation. It’s also the only DCB indicated for treating patients with multivessel disease, acute coronary syndrome, and diabetes.

The approval follows Prevail DCB’s performance in a large, real-world, complex patient population from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). In a late-breaking trial the DCB showed low event rates at two 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 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 this week. In 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 one year.

“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 Medtronic’s Coronary & Renal Denervation business. “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.”