Medtronic has submitted its first pre-market approval (PMA) module to the U.S. Food and Drug Administration (FDA) for the IN.PACT Admiral drug-eluting balloon designed to treat atherosclerotic lesions in the superficial femoral artery (SFA).
IN.PACT Admiral is coated with a proprietary substance called FreePac, which is a formulation of the antiproliferative drug paclitaxel and the biocompatible excipient urea, which facilitates rapid absorption of the drug into the vessel wall. The balloon has been CE marked since 2008.
The total ongoing clinical program includes 24 studies involving more than 4,200 patients at approximately 230 sites worldwide.
The clinical program which involves both physician-initiated and company-sponsored studies will fully characterize the safety and efficacy of these combination devices in a variety of peripheral vascular beds, including below-the-knee arteries.
Medtronic Endovascular Therapies business president Tony Semedo said, "In the meantime, we will continue working with leading healthcare providers and researchers around the world to amass clinical and economic evidence to support the global adoption of this innovative medical technology as an important addition to the treatment options for peripheral artery disease in the lower extremities."
In the US, the IN.PACT Admiral drug-eluting balloon is limited to investigational use under an investigational device exemption (IDE) granted by the FDA.
Medtronic intends to launch the IN.PACT Admiral drug-eluting balloon in the US during the second half of calendar year 2015, pending FDA approval.