EffPac Trial Data for iVascular's Luminor DCB Presented at LINC

February 22, 2018—iVascular SLU recently announced that the 6-month results from the EffPac trial were presented by Prof. Dierk Scheinert, MD, at LINC 2018, the Leipzig Interventional Course held January 30 to February 2 in Leipzig, Germany. The EffPac randomized controlled study compared the company's Luminor drug-coated balloon (DCB) versus plain old balloon angioplasty (POBA) in femoropopliteal lesions.

At LINC 2018, Prof. Scheinert reported that primary and secondary endpoints in EffPac were achieved with high statistical significance. The primary endpoint of late lumen loss was 0.14 mm in the DCB group versus 1.06 mm in the POBA group (P < .001). Target lesion revascularization was 1.3% for DCB versus 17.1% for POBA (P < .001). Primary patency was 94.7% for DCB versus 75% for POBA (P < .001). Rutherford stages improved overall for 85.2% patients in the DCB group versus 75% in the POBA group (P = .021), and by three stages for 44.6% patients in the DCB group versus 27.8% in the POBA group.

Luminor is a paclitaxel-coated balloon that uses nanotechnology for minimized drug loss during navigation and enhanced delivery to the artery wall. The device is available in a full range of sizes with 0.014-, 0.018-, and 0.035-inch guidewire compatibility. The Luminor DCB received European CE Mark approval in 2013 to treat superficial femoral, popliteal, and infrapopliteal arteries.