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diamondback 360 dbx

Cardiovascular Systems

Summary: The Diamondback 360 DBX is an atherectomy device used to remove plaque from blood vessels. It is primarily used by interventional cardiologists and vascular surgeons in the treatment of peripheral arterial disease.

FDA Clearance Information

Pathway 510K
Number K090521 ↗
Decision Date March 20, 2009
Product Code MCW
Device Class Class 2
Evidence 19 studies

The Diamondback 360 DBX, manufactured by Cardiovascular Systems, was cleared through the FDA 510(k) pathway on March 20, 2009. It is a Class 2 medical device under product code MCW.

What It Is

The Diamondback 360 DBX is a rotational atherectomy device designed to remove atherosclerotic plaque from peripheral arteries. It uses a diamond-coated crown that spins at high speeds to sand away plaque while preserving the vessel wall. This device is particularly useful in treating calcified lesions that are difficult to manage with balloon angioplasty alone.

Clinical Applications

The Diamondback 360 DBX is commonly used in the treatment of peripheral arterial disease, especially in cases involving calcified lesions in the lower extremities. Interventional cardiologists and vascular surgeons use this device in hospital catheterization labs and outpatient settings. It is often employed in patients who have claudication or critical limb ischemia, aiming to improve blood flow and alleviate symptoms.

Indications for Use

The FDA indications for the Diamondback 360 DBX include the removal of atherosclerotic plaque in peripheral arteries. It is intended for patients with peripheral arterial disease, particularly those with calcified lesions that are challenging to treat with other methods.

Practical Considerations

The Diamondback 360 DBX is available in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and catheters used in peripheral interventions. Clinicians should be trained in rotational atherectomy techniques to ensure safe and effective use.

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 is Diamondback 360 DBX used for?

The Diamondback 360 DBX is used for removing plaque from peripheral arteries, particularly in patients with calcified lesions.

What specialties typically use this device?

Interventional cardiologists and vascular surgeons typically use the Diamondback 360 DBX.

What are the FDA-cleared indications?

The device is indicated for the removal of atherosclerotic plaque in peripheral arteries, especially in cases of calcified lesions.

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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