Medtronic has submitted the final module of its pre-market approval (PMA) application to the US Food and Drug Administration (FDA) for its IN.PACT Admiral drug-coated balloon designed for the treatment of peripheral artery disease.
The final pre-market approval module includes pivotal data from the IN.PACT SFA trial evaluating IN.PACT Admiral to treat peripheral artery disease in the superficial femoral artery (SFA) or proximal popliteal artery, compared to standard balloon angioplasty.
According to Medtronic, the study demonstrated superior clinical outcomes compared with conventional angioplasty, with the lowest rates of repeat procedures (target lesion revascularization) and the highest rate of uninterrupted blood flow (primary patency) at 12 months.
Medtronic endovascular therapies business president Tony Semedo said that this exciting milestone keeps the company on track for FDA approval of the IN.PACT Admiral drug-coated balloon in the US in early FY16.
"More than 1,000 patients have been enrolled in the studies submitted to the FDA. The breadth and depth of our clinical program is unparalleled in the treatment of femoropopliteal disease across both randomized, controlled trials and real-world studies," Semedo added.
The PMA application also includes new data from the first 650 patients in the IN.PACT Global study, a real-world 1,500-patient evaluation of the IN.PACT Admiral drug-coated balloons for the treatment of femoropopliteal lesions providing important data about more complex anatomical and clinical patient characteristics.
Medtronic claims that the IN.PACT Admiral drug-coated balloon leaves no scaffolding behind in the SFA. FreePac coating enables rapid absorption of the drug into the vessel wall and prevents excess scar tissue from forming along the wall of the treated arterial segment.
FreePac is a formulation of the antiproliferative drug paclitaxel and the natural excipient urea. The IN.PACT Admiral drug-coated balloon received the CE Mark approval in 2009.
Image: Medtronic’s world headquarters in Minneapolis. Photo: Courtesy of Medtronic, Inc.