Medtronic ($MDT), buoyed by robust clinical data from over 1,000 patients, will submit the first part of its FDA PMA application over the summer for a drug-eluting balloon to treat hardening of the arteries in the upper leg. If all goes well, plans call for launching the novel angioplasty device in the U.S. by late 2015.
The Minnesota device giant said it pulled the trigger to go ahead with its premarket approval application for the IN.PACT Admiral drug-eluting balloon after finally enrolling enough patients to support the final stage. The company said it surpassed the 1,000 mark for the IN.PACT SFA I, II, II pharmacokinetics and Global studies. Those efforts are part of a larger clinical program including a whopping 4,600 patients in 29 studies around the world.
IN.PACT Admiral elutes a drug coating of paclitaxel and urea (known as FreePac) designed to help make the drug absorb better into the vessel wall. It is designed to treat peripheral artery disease in the superficial femoral artery (from the groin to the knee). The IN.PACT line has had CE mark status since 2008-2009 but remains investigational in the U.S.
Tony Semedo, president of Medtronic's Endovascular Therapies business, said in a statement that he sees the treatment standing out because "it targets atherosclerotic lesions in the superficial femoral artery with a treatment modality that aims to deliver an anti-restenotic drug while leaving nothing behind."
Last month, the company celebrated a study involving its IN.PACT Falcon drug-eluting balloon, which it said proved to be superior to Boston Scientific's ($BSX) Taxus stent to treat patients with lesions in small coronary arteries.
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