On December 30, 2014, the Food and Drug Administration (FDA) approved the In.Pact Admiral drug-coated balloon (DCB) catheter (Medtronic) for percutaneous transluminal angioplasty (PTA) in patients with obstructed arteries in the upper leg due to peripheral artery disease (PAD). In.Pact Admiral is the second drug-coated PTA balloon catheter approved by the FDA. In October 2014, the FDA approved the Lutonix 035 DCB PTA Catheter (Lutonix DCB) to treat PAD.
The In.Pact Admiral DCB catheter is indicated for PTA, after predilatation, of de novo or restenotic lesions up to 180 millimeters (mm) in length in native superficial femoral arteries (SFA) or popliteal arteries with reference vessel diameters of 4 to 7 mm. FDA approval was based on the results of the recently published In.Pact SFA trial. This trial randomized adults with moderate to severe intermittent claudication or ischemic rest pain due to SFA and/or proximal popliteal artery disease to undergo PTA using either the In.Pact Admiral DCB (n=220) or a standard PTA balloon (n=111). One year after the procedure, the primary patency rate was significantly higher in the DCB group than in the standard balloon group (82.2% versus 52.4%, respectively).
PAD is a chronic narrowing of arteries of the lower extremities that typically results from atherosclerosis. It affects an estimated 8 million people in the United States, although only approximately one third are symptomatic.