Treatment of lower extremity vascular disease: the Diamondback 360°™ Orbital Atherectomy System

Abstract

Atherosclerotic disease affecting the arteries of the lower extremities becomes symptomatic with the onset of pain either at rest or with ambulation. The disease, commonly referred to as peripheral arterial disease (PAD), affects nearly 30 million individuals in Europe and North America alone. The predominant factor responsible for the impaired functional capacity and quality of life in the presence of lower-extremity PAD is inadequate blood flow due to atherosclerotic plaque build-up within the arteries. Without successful lifestyle risk modifications or judicious pharmacotherapy, individuals with lower-extremity PAD may develop disabling complications that require endovascular treatment, bypass surgery or amputation of the affected extremity. The Diamondback 360°™ Orbital Atherectomy System is a promising new methodology for treating symptomatic PAD within the major and branch arteries of the leg. The device differs from other atherectomy technologies by its unique orbiting action to remove plaque and the ability to increase lumen diameter by increasing the orbital speed. Applying the principles of centrifugal force, an eccentrically mounted diamond-coated crown rotates at high speed to sand away plaque as the crown is slowly advanced through the narrowed or occluded section of artery. As crown rotation increases, centrifugal force presses the crown against the stenotic lesion to effect plaque removal, while the less diseased, more elastic arterial wall flexes away from the crown, minimizing the risk of vessel trauma. The increasing crown orbit creates a larger lumen and minimizes procedure time and the need for catheter upsizing. This device profile presents an overview of the prevalence and symptoms of PAD, describes the Diamondback 360 Orbital Atherectomy System components and mechanism of action, and closes with a case study review and perspective regarding how lower-extremity PAD will be treated in the next 5 years.