AngioScore announced the launch of new, longer AngioSculpt PTA Scoring Balloon Catheters for the treatment of peripheral artery disease. The new devices have received FDA 510(k) clearance to market for the dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
These new peripheral artery disease catheters are not labeled for use in the coronary or neuro-vasculature.
The new AngioSculpt devices incorporate longer (40 mm) balloons and scoring elements in diameters 2.0, 2.5, 3.0 and 3.5mm. These new sizes are expected to be particularly useful in treating lesions typically encountered in the treatment of complex peripheral artery disease below the knee. Barry Weinstock, interventional cardiologist, Orlando Regional Medical Center, commented, “These new longer AngioSculpt devices represent a significant improvement over conventional angioplasty balloons for the treatment of complex lesions because of their ability to achieve more predictable luminal expansion and a lower rate of dissection, thereby minimising the need to perform adjunctive stenting. This advantage is particularly important when working below the knee as stenting in those vessels is generally undesirable.”
Thomas R Trotter, president and CEO of AngioScore, added, “The peripheral artery disease market is one of the rapidly growing segments of the overall interventional cardiovascular market worldwide. Over 1.5 million percutaneous peripheral procedures are now being performed annually worldwide, and the growth rate is accelerating due to improved diagnosis and the increasing incidence 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.”
AngioSculpt represent the next generation in angioplasty balloon catheters for both coronary and peripheral artery disease. Their innovative nitinol scoring elements provide unique circumferential scoring of plaque, leading to precise and predictable luminal enlargement across a wide range of lesion types while avoiding “geographic miss” through their unique anti-slippage properties.