Medtronic has started IN.PACT SFA II clinical trial for its IN.PACT drug-eluting balloons in the US.
The controlled, multicenter, prospective, randomized trial is designed to assess the safety and effectiveness of the company’s IN.PACT Admiral drug-eluting balloon, with a traditional non-coated angioplasty balloon, in the treatment of peripheral artery disease in the superficial femoral artery and/or proximal popliteal artery.
Specifically, the trial will examine the effect of the device for treating de novo and non-stented restenotic atherosclerotic lesions in the vessel beds.
Medtronic said once the trial is completed, data from the company’s IN.PACT SFA II study will be combined with the company’s IN.PACT SFA I study, and is intended to support a premarket approval (PMA) application to the US Food and Drug Administration (FDA).
IN.PACT drug-eluting balloons feature a proprietary coating made of paclitaxel and urea, FreePac, an excipient that facilitates absorption of the drug into the vessel wall.
IN.PACT balloons received CE mark approvals in 2008 and 2009 and is not available in the US.