diamondback 360 peripheral orbital atherectomy system exchangeable series

The Diamondback 360 Peripheral Orbital Atherectomy System is designed to remove plaque from peripheral arteries using an orbital mechanism. It is intended for use in patients with peripheral arterial disease to improve blood flow by modifying calcified plaque.

This device is commonly used in clinical scenarios such as critical limb ischemia and when there is a need to optimize vascular access for procedures like trans-catheter aortic valve replacement. It is particularly useful in cases with heavily calcified arteries.

The available literature includes 7 studies, ranging from retrospective analyses to observational studies, published between 2015 and 2020. These studies explore various clinical applications and economic impacts of the device.

Published studies report that the Diamondback 360 is effective in facilitating revascularization in patients with peripheral arterial disease. It has been shown to reduce vessel calcification, aiding in procedures like angioplasty and TAVR. Economic analyses suggest potential cost benefits when used in conjunction with balloon angioplasty.

Reported complications include guidewire fractures during the procedure, as noted in the MAUDE database. These events, while not systematically studied, highlight the need for careful procedural management to mitigate risks.

The current evidence is limited by the lack of large-scale randomized controlled trials. Most studies are observational or retrospective, which may introduce bias. Further research is needed to systematically evaluate long-term outcomes and safety.