By Fineline Cube 
US-Irish firm Medtronic (NYSE: MDT) announced that its Prevail paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter (drug-coated balloon, DCB) has received CE Mark certification in the European Union. This certification expands the device’s indications for treating various coronary artery disease (CAD) conditions, making it the only DCB approved for treating multivessel disease, acute coronary syndrome (ACS), and diabetic patients.
Broadest CE-Approved Indications
The Prevail DCB now holds the broadest CE-approved indications among DCBs, including bifurcation lesions. This approval underscores Medtronic’s commitment to advancing cardiovascular treatments and providing healthcare professionals with versatile tools to address complex coronary conditions.
Clinical Trial Data
At the Cardiovascular Research Technologies (CRT) conference, clinical trial data revealed the Prevail DCB’s effectiveness, showing low event rates over two years. The data highlighted a 6.1% rate of new-onset myocardial infarction (MI), a 7.4% target lesion revascularization (TLR) rate, and a 0.8% incidence of definitive target lesion thrombosis. In hybrid percutaneous coronary intervention (PCI) procedures, which combine DCB and drug-eluting stents (DES), the Prevail DCB demonstrated numerically lower rates of new-onset MI compared to other DCBs.-Fineline Info & Tech