These new AngioSculpt catheters have received U.S. Food and Drug Administration (FDA) 510(k) clearance to market for the dilatation of lesions in the iliac; femoral; iliofemoral; popliteal; infrapopliteal; and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. They are not labeled for use in the coronary or neurovasculature.
The catheters incorporate longer 100 mm scoring balloons in diameters of 2, 2.5, 3 and 3.5 mm. These catheters are expected to be particularly useful in treating complex lesions typically encountered in the treatment of patients with critical limb ischemia (CLI) and infrapopliteal PAD.
“These longer AngioSculpt Scoring Balloon Catheters provide physicians with important new devices for the treatment of challenging lesions below the knee because of their ability to achieve more predictable luminal expansion and a very low rate of dissection, potentially minimizing the need to perform adjunctive stenting,” said Thomas P. Davis, M.D., director of the cardiac catheterization lab and director of peripheral interventions and disease at St. John Hospital and Medical Center in Detroit.
For more information: www.angioscore.com