📊 Evidence-Based Reference

diamondback 360 degree orbital atherectomy system

Cardiovascular Systems

Summary: The Diamondback 360 Orbital Atherectomy System is a device used for atherectomy in calcified coronary and peripheral arterial lesions. Key evidence highlights its efficacy in treating severely calcified lesions with favorable procedural outcomes.

FDA Clearance Information

Pathway 510K
Decision Date August 22, 2007
Product Code MCW
Device Class Class 2
Evidence 19 studies

The Diamondback 360 Orbital Atherectomy System was cleared by the FDA via the 510(k) pathway on August 22, 2007. It is manufactured by Cardiovascular Systems and classified as a Class 2 device under product code MCW.

What It Is

The Diamondback 360 is an orbital atherectomy system designed to remove calcified plaque from coronary and peripheral arteries. It uses a diamond-coated crown that orbits within the vessel, sanding away plaque while preserving healthy tissue.

Clinical Applications

This device is commonly used in the treatment of peripheral arterial disease (PAD) and severely calcified coronary lesions. It is particularly useful in patients with limited blood flow due to atherosclerotic plaque build-up.

Evidence Summary

The available literature includes six studies, comprising randomized controlled trials and observational studies, conducted between 2008 and 2023. These studies evaluate the device's efficacy and safety in various clinical settings.

Reported Outcomes

Published studies report favorable procedural outcomes with the Diamondback 360 in treating severely calcified lesions. Optical coherence tomography imaging has quantified the ablation volume, demonstrating its effectiveness in plaque removal. Initial experiences in Europe also indicate successful application in clinical practice.

Safety Profile

Reported complications include potential vessel injury and procedural complications typical of atherectomy procedures. However, specific adverse events were not detailed in the provided evidence.

Evidence Limitations

The evidence is limited by the small number of studies and lack of long-term follow-up data. Further research is needed to assess long-term safety and efficacy, as well as comparisons with other atherectomy devices.

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 Orbital Atherectomy System?

The device is indicated for the treatment of calcified coronary and peripheral arterial lesions, particularly in patients with peripheral arterial disease (PAD).

What outcomes have been reported in clinical studies?

Studies have reported favorable procedural outcomes, including effective plaque removal and improved blood flow in treated vessels.

What complications have been reported?

Reported complications include potential vessel injury and procedural complications, though specific adverse events were not detailed in the evidence provided.

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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