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diamondback 360 orbital atherectomy system stealth 360 orbital pad system

Cardiovascular Systems

Summary: The Diamondback 360 Orbital Atherectomy System is a device used for the treatment of calcified coronary and peripheral artery lesions. Key evidence suggests its cost-effectiveness and efficacy in debulking calcified lesions.

FDA Clearance Information

Pathway 510K
Number K111388 ↗
Decision Date July 26, 2011
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 July 26, 2011. It is manufactured by Cardiovascular Systems and classified as a Class 2 device.

What It Is

The Diamondback 360 Orbital Atherectomy System is designed to remove calcified plaque from coronary and peripheral arteries. It utilizes a diamond-coated crown that rotates to sand away plaque, facilitating subsequent angioplasty or stenting.

Clinical Applications

This device is commonly used in patients with severely calcified coronary lesions and peripheral artery disease, particularly when traditional angioplasty is insufficient. It is often employed as an adjunctive therapy to improve vessel compliance.

Evidence Summary

The available literature includes 11 studies, comprising randomized controlled trials and observational studies, conducted between 2013 and 2017. These studies evaluate the device's cost-effectiveness, efficacy, and safety in various clinical settings.

Reported Outcomes

Published studies report favorable procedural outcomes with the Diamondback 360 Orbital Atherectomy System, including improved vessel patency and reduced restenosis rates. Cost-effectiveness analyses suggest economic benefits when used in conjunction with balloon angioplasty compared to angioplasty alone.

Safety Profile

Reported complications include potential vessel injury and dissection, which are inherent risks of atherectomy procedures. However, the studies reviewed did not highlight any new or unexpected safety concerns specific to this device.

Evidence Limitations

The evidence is limited by the relatively small sample sizes and short follow-up durations in some studies. Further research is needed to assess long-term outcomes and to compare the device's efficacy directly with other atherectomy systems.

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 severely calcified coronary and peripheral artery lesions, particularly when traditional angioplasty is inadequate.

What outcomes have been reported in clinical studies?

Studies report improved vessel patency and cost-effectiveness when used with balloon angioplasty, with favorable procedural outcomes.

What complications have been reported?

Safety data indicate risks of vessel injury and dissection, common to atherectomy procedures, but no unique safety concerns were identified.

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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