Mercator’s Bullfrog micro-infusion device tested to improve durability after femoropopliteal revascularization
Two-year data from Mercator Medsystem‘s Dance trial were presented at the VIVA conference this year by Dr. George Adams. The trial provides the largest, long-term data set assessing patency rates in atherectomy patients with adjunctive local drug therapy, according to the presentation.
The study was designed to evaluate the safety and efficacy of adventitial dexamethasone delivery, via Mercator’s Bullfrog micro-infusion device, to improve durability after femoropopliteal revascularization.
The Dance trial’s atherectomy subgroup included 157 limbs, according to the research team, and participants were eligible for the study if they had lesions in the femoral and/or popliteal arteries up to 15 centimeters in length, as well as Rutherford 2-4 peripheral artery disease.
Atherectomy methods included directional, rotational, laser and front-cutting, the team said, and stenting didn’t prevent subjects from enrolling in the trial.
The Bullfrog micro-infusion device delivered dexamethasone sodium phosphate with 20% contrast medium after atherectomy and prior to any stenting. Researchers followed up with patients after 6, 12, 18 and 24 months.
Primary patency was determined by lack of binary restenosis or clinically driven target lesion revascularization. The preliminary two-year primary patency rate was 72.8% and freedom from CD-TLR was 85.2%.