Optimal techniques with the Diamondback 360° System achieve effective results for the treatment of peripheral arterial disease

Abstract

The Diamondback 360® Orbital PAD System (DB360) is a novel orbital atherectomy system for the treatment of calcified lower extremity lesions associated with peripheral arterial disease (PAD). This percutaneous, endovascular system incorporates the use of centrifugal force and differential sanding to modify plaque morphologies. The mechanism of differential sanding discriminates between compliant arterial tissue and diseased fibro-calcific or calcific plaque. An eccentrically mounted diamond-coated crown orbits at high speeds and removes a thin layer of calcific plaque with each pass of the crown. The crown creates a more concentric, smooth vessel lumen with increased diameter, increased lesion compliance and improved blood flow while protecting the vessel media. As a result, the risk for post-procedure thrombus formation and potential for restenosis may be reduced. The risk of intra-procedural events (slow flow, hemolysis, spasm and pain) may be reduced due to the design of this orbital sanding system along with proper technique. Extensive benchtop, in vivo, and clinical testing has confirmed these results and is presented within this paper. In addition, guidelines for selecting the most appropriate crown size and type (solid versus classic) and step-by-step procedural technique and pharmacology information are presented. The DB360 System provides a safe, efficacious, and cost-effective endovascular method for PAD treatment. Careful understanding of procedural methods, use of pharmacological drugs, and understanding of device operation contributes to improved treatment success.