Medtronic, Bard In Close Race To First FDA-Approved Drug-Eluting Balloon

Article preview from "The Gray Sheet" - June 10, 2013

Medtronic says it reached the necessary trial enrollment to support PMA approval for its IN.PACT Admiral drug-eluting balloon catheter to treat atherosclerosis in the superficial femoral artery. On the same day, CR Bard said it was prepared to submit its final PMA module for its Lutonix drug-eluting balloon by year’s end.

Medtronic, Bard In Close Race To First FDA-Approved Drug-Eluting Balloon

Article preview from "The Gray Sheet" - June 10, 2013

Medtronic Inc. 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 last 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. Medtronic will ask the agency to approve the IN.PACT Admiral for treatment of atherosclerotic lesions in the superficial femoral artery.

Medtronic’s IN.PACT clinical program covers 29 studies with more than 4,600 patients treated at 230 sites around the world, according to the company. The firm’s PMA will include data from the IN.PACT SFA I European study, the IN.PACT SFA II study, pharmacokinetic studies and the IN.PACT Admiral global clinical study.

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