Medtronic enrolls first patient in new coronary DCB trial—data could lead to FDA approval

Prevail DCB Medtronic. Medtronic’s Prevail drug-coated balloon (DCB) has received CE mark approval for several new indications related to the treatment of coronary artery disease (CAD). The paclitaxel-coated device, designed to inflate within the patient’s artery during percutaneous coronary intervention (PCI) procedures, is now approved across the EU to treat CAD patients with multivessel disease, acute coronary syndrome and diabetes.

Prevail DCB graphic courtesy of Medtronic. 

The paclitaxel-coated device, already approved in Europe and other parts of the world, will be tested on more than 1,200 patients for a new international trial. If the study is a success, Medtronic hopes to gain regulatory approval in the United States and Japan.