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diamonback 360 peripheral orbital atherectomy system diamondback 360 stealth orbital atherectomy system

Cardiovascular Systems

Summary: The Diamondback 360 is an orbital atherectomy system used for plaque modification in peripheral artery disease. Key evidence highlights its effectiveness in treating calcified lesions and optimizing vascular access.

FDA Clearance Information

Pathway 510K
Number K210586 ↗
Decision Date September 14, 2021
Product Code MCW
Device Class Class 2
Evidence 19 studies

The Diamondback 360 was cleared by the FDA via the 510(k) pathway on September 14, 2021. It is manufactured by Cardiovascular Systems and classified as a Class 2 device.

What It Is

The Diamondback 360 is an orbital atherectomy system designed to modify plaque in peripheral arteries. It uses orbital sanding and pulsatile forces to treat atherosclerotic lesions, facilitating revascularization in patients with peripheral artery disease.

Clinical Applications

Commonly used in scenarios involving heavily calcified peripheral arteries, the Diamondback 360 is particularly useful in treating femoropopliteal lesions and optimizing access for procedures like trans-catheter aortic valve replacement (TAVR).

Evidence Summary

The literature includes 10 studies ranging from 2016 to 2020, encompassing randomized controlled trials, prospective and retrospective studies, and case series. These studies explore the device's efficacy and safety in various clinical settings.

Reported Outcomes

Published studies report that the Diamondback 360 is effective in modifying calcified lesions, improving lesion compliance, and facilitating successful revascularization. It has shown promise in reducing acute complications compared to balloon angioplasty.

Safety Profile

Reported complications include guidewire fractures during the procedure, as highlighted in a review of the MAUDE database. Other studies have not systematically addressed safety outcomes, indicating a need for further research.

Evidence Limitations

Current evidence is limited by the lack of large-scale, long-term studies. Many studies focus on specific clinical scenarios, and there is a need for broader research to fully understand the device's safety profile and long-term efficacy.

Linked Studies (19)

PubMed • 2023

Coronary Intra-orbital Atherectomy Complications and Procedural Failure: Insight From the Manufacturer and User Facility Device Experience (MAUDE) Database.

Cureus

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

Initial experience with orbital atherectomy in a tertiary centre in the Netherlands.

Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, Harmonization by Doing Proof-of-Concept.

Cardiovascular revascularization medicine : including molecular interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

Coronary orbital atherectomy using a five-French guiding catheter.

Cardiovascular intervention and therapeutics

View Source →
PubMed • 2021

Is crossability of the classic crown with the glide assist superior to the micro crown in the Diamondback 360® coronary orbital atherectomy system?

Cardiovascular intervention and therapeutics

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2019

Orbital atherectomy for calcified femoropopliteal lesions: a current review.

The Journal of cardiovascular surgery

View Source →
PubMed • 2019

Iliofemoral peripheral orbital atherectomy for optimizing TAVR access: An innovative strategy in the absence of alternative access options.

Cardiovascular revascularization medicine : including molecular interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2018

Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial.

Cardiovascular revascularization medicine : including molecular interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2017

The potential cost-effectiveness of the Diamondback 360® Coronary Orbital Atherectomy System for treating de novo, severely calcified coronary lesions: an economic modeling approach.

Therapeutic advances in cardiovascular disease

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2017

Quantification by optical coherence tomography imaging of the ablation volume obtained with the Orbital Atherectomy System in calcified coronary lesions.

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2017

Critical hand ischemia treatment via orbital atherectomy-A single center observational retrospective analysis.

Cardiovascular revascularization medicine : including molecular interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2015

Evaluation of the Diamondback 360 Coronary Orbital Atherectomy System for treating de novo, severely calcified lesions.

Expert review of medical devices

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2015

Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial).

The American journal of cardiology

View Source →
PubMed • 2015

Orbital atherectomy: device evolution and clinical data.

The Journal of invasive cardiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2014

Cost-effectiveness analysis of orbital atherectomy plus balloon angioplasty vs balloon angioplasty alone in subjects with calcified femoropopliteal lesions.

ClinicoEconomics and outcomes research : CEOR

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2011

Orbital atherectomy for symptomatic lower extremity disease.

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2011

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

Journal of cardiovascular translational research

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2009

Use and abuse of atherectomy: where should it be used?

Seminars in vascular surgery

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2008

Treatment of lower extremity vascular disease: the Diamondback 360 degrees Orbital Atherectomy System.

Expert review of medical devices

RCT|prospective|retrospective|case Series|other View Source →

Frequently Asked Questions

What are the clinical indications for Diamondback 360?

The Diamondback 360 is indicated for plaque modification in peripheral artery disease, particularly in calcified lesions.

What outcomes have been reported in clinical studies?

Studies report effective lesion modification and improved revascularization outcomes, with reduced acute complications compared to balloon angioplasty.

What complications have been reported?

Safety data indicate guidewire fractures as a complication, with limited systematic reporting on other adverse events.

Related Device Categories

Atherectomy Devices
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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