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modification to diamondback 360 orbital atherectomy system

Cardiovascular Systems

Summary: The Diamondback 360 Orbital Atherectomy System is a device used for plaque modification in calcified lesions. It is primarily used in peripheral and coronary artery disease. Key evidence highlights its efficacy in reducing calcification and improving vessel patency.

FDA Clearance Information

Pathway 510K
Number K072748 ↗
Decision Date November 9, 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 November 9, 2007. It is manufactured by Cardiovascular Systems and classified as a Class 2 device.

What It Is

The Diamondback 360 Orbital Atherectomy System is a mechanical device designed to modify calcified plaque in arterial lesions. It operates through high-speed elliptical crown rotation, facilitating plaque modification in both peripheral and coronary arteries.

Clinical Applications

This device is commonly used in clinical scenarios involving calcified coronary and peripheral artery lesions. It is particularly useful in percutaneous coronary interventions (PCI) and peripheral revascularization procedures.

Evidence Summary

The available literature includes 11 studies, comprising various study types such as RCTs and observational studies, conducted between 2019 and 2025. These studies explore the device's efficacy and safety in different clinical settings.

Reported Outcomes

Published studies report that the Diamondback 360 Orbital Atherectomy System is effective in reducing calcification and improving vessel patency in both coronary and peripheral arteries. The device has demonstrated efficacy in treating calcified lesions, facilitating successful revascularization.

Safety Profile

Reported complications include guidewire fractures during procedures, as noted in the MAUDE database. These events, while not systematically studied, highlight the need for careful procedural planning and execution.

Evidence Limitations

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 establish long-term outcomes and safety profiles.

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 use in modifying calcified plaque in coronary and peripheral artery lesions.

What outcomes have been reported in clinical studies?

Studies have reported improved vessel patency and reduced calcification in treated lesions.

What complications have been reported?

Safety data indicate potential complications such as guidewire fractures during procedures.

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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