Ex-vivo results using a new pullback atherectomy catheter (PAC).

In order to evaluate the feasibility of performing definitive atheromatous plaque removal using a novel retrograde cutting (Pullback) atherectomy catheter, pullback atherectomy was performed in 13 severely diseased cadaveric superficial femoral arteries. All experiments were performed using cadaver tissue either mounted in a perfusion/mounting chamber (n = 10) or left in situ (n = 3). In general, a single cut was made with each of three sequentially larger atherectomy catheters (2.5 mm, 3.0 mm, and then 3.5 mm devices). The results were evaluated by angiography and by light microscopy. Nine of the 13 experiments were performed in totally occluded vessels. The mean pre-atherectomy stenosis (all specimens) was 95 +/- 3%, with a final mean postatherectomy stenosis of 21 +/- 5%. There was one vessel performation. We conclude from these preclinical studies that retrograde atherectomy with the Pullback Atherectomy Catheter is a feasible means of performing definitive atherectomy. Despite the promising potential of retrograde atherectomy, little can be said with certainty about the clinical utility of such a device at this early stage.