Global Leader Projects Introduction of IN.PACT Admiral Drug-coated Balloon to U.S. Market in Early FY16

MINNEAPOLIS - Moving toward U.S. market introduction of its novel medical device to treat peripheral artery disease, Medtronic, Inc. (NYSE: MDT) today announced that it recently submitted the final module of its pre-market approval (PMA) application for the IN.PACT Admiral drug-coated balloon to the U.S. Food and Drug Administration (FDA). The application includes data that demonstrates 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 ever reported for the interventional treatment of peripheral artery disease.

"This exciting milestone keeps us on track for FDA approval of the IN.PACT Admiral drug-coated balloon in the U.S. in early FY16," reaffirmed Tony Semedo, president of Medtronic's endovascular therapies business. "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."


The final PMA module includes landmark pivotal data recently presented at Charing Cross and EuroPCR annual meetings from the IN.PACT SFA Trial, investigating IN.PACT Admiral for the treatment of peripheral artery disease in the superficial femoral artery (SFA) or proximal popliteal artery (both located in the leg above the knee), compared to standard balloon angioplasty. At 12 months follow-up, both primary endpoints showed a highly statistically significant difference between treatment groups:

Clinically driven target lesion revascularization (CD-TLR) rates were 2.4 percent in the drug-coated balloon (DCB) patients and 20.6 percent for the percutaneous transluminal angioplasty (PTA) patients (p<0.001).

Primary patency rates were 82.2 percent for the DCB patients and 52.4 percent for the PTA patients (p<0.001). Primary patency calculated by Kaplan-Meier survival estimates at 360 days was 89.8 percent for the DCB patients and 66.8 percent for the PTA patients.
Also included in the application is new data from the first 650 patients in the IN.PACT Global study, a first-of-its-kind, "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.

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