AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, today announced the launch of its new 100 mm length AngioSculpt PTA Scoring Balloon Catheters for the treatment of peripheral artery disease (PAD) below the knee (BTK).
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; infra-popliteal; 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 neuro-vasculature.
The catheters incorporate longer 100 mm Scoring Balloons in diameters of 2.0, 2.5, 3.0 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 infra-popliteal PAD. 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 (Detroit, Mich.), commented: "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."
Thomas R. Trotter, president and CEO of AngioScore, added: "The peripheral artery disease market is a rapidly growing segment of the interventional cardiovascular market. Over a million percutaneous peripheral procedures are now being performed annually worldwide, and the PAD market continues to demonstrate significant growth due to improved diagnosis and the increasing prevalence of important risk factors such as adult onset diabetes mellitus. We believe that the AngioSculpt line of Scoring Balloon Catheters is particularly useful in treating this very challenging and serious disease."