Medtronic PLC and CR Bard Inc. appear to be in a close race to become the first to market a drug-eluting balloon catheter in the U.S. Both firms announced major milestones this week for pivotal trials of their drug-eluting balloons targeting the peripheral arteries.
Medtronic said June 3 it has enrolled more than 1,000 patients in clinical studies of its IN.PACT Admiral paclitaxel-eluting balloon. The firm says those patients will provide enough data to support a PMA for the device, and Medtronic plans to submit the first module of a PMA this summer