Novel Angioplasty Catheters Treat Peripheral Cardiovascular Disease

The AngioSculpt scoring balloon catheter devices are intended for the dilatation of lesions in the iliac, femoral, iliofemoral, popliteal, and infra popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The devices incorporate 40 mm balloons and scoring elements in diameters of 2, 2.5, 3, and 3.5 mm. 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 antislippage properties.

The flexible nitinol-scoring element is comprised of three or four rectangular spiral struts that work in tandem with a semicompliant balloon to score the target lesion. The balloon inflation focuses uniform radial forces along the edges of the nitinol element, scoring the plaque and resulting in a more precise and predictable outcome. The device also offers reduced dissection rates, better final luminal dimensions, and zero perforations. The AngioSculpt scoring balloon catheter devices are products of AngioScore (Fremont, CA, USA), and have been approved by the US Food and Drug Administration (FDA).

"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 minimizing the need to perform adjunctive stenting,” said Barry Weinstock, MD, an interventional cardiologist at Orlando Regional Medical Center (FL, USA). "This advantage is particularly important when working below the knee as stenting in those vessels is generally undesirable.”

"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,” added Thomas Trotter, president and CEO of AngioScore. "The peripheral artery disease market is one of the rapidly growing segments of the overall interventional cardiovascular market worldwide. We believe that the AngioSculpt line of scoring balloon catheters is particularly useful in treating this very challenging and serious disease.”

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