LAVascular
Contact Us
đź“Š Evidence-Based Reference

modification to diamondback 360 degree orbital atherectomy system

Cardio Systems

Summary: The Diamondback 360 Orbital Atherectomy System by Cardio Systems is used for treating peripheral arterial disease. Key evidence includes its initial use in Europe and treatment of lower extremity vascular disease.

FDA Clearance Information

Pathway 510K
Number K081944 ↗
Decision Date August 14, 2008
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 14, 2008. It is manufactured by Cardio Systems and is classified as a Class 2 device.

What It Is

The Diamondback 360 Orbital Atherectomy System is a device designed to remove atherosclerotic plaque from peripheral arteries. It uses a diamond-coated crown that rotates at high speeds to sand away plaque, improving blood flow.

Clinical Applications

This device is commonly used in patients with peripheral arterial disease (PAD) to alleviate symptoms such as pain during rest or ambulation. It is particularly useful in cases where plaque build-up significantly impairs blood flow.

Evidence Summary

The available literature includes two studies: one from 2008 and another from 2023. These studies encompass various methodologies, including prospective and retrospective analyses, focusing on the device's application in lower extremity vascular disease.

Reported Outcomes

Published studies report that the Diamondback 360 Orbital Atherectomy System effectively reduces plaque in peripheral arteries, improving blood flow and alleviating symptoms of PAD. The 2023 study highlights its successful initial use in a European tertiary center.

Safety Profile

Reported complications include typical risks associated with atherectomy procedures, such as arterial dissection and embolization. However, specific safety data from the provided studies is limited.

Evidence Limitations

The evidence is limited by the small number of studies and lack of detailed safety outcomes. Further research is needed to establish long-term efficacy and safety, as well as to explore its use in diverse patient populations.

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?

The device is indicated for the treatment of peripheral arterial disease, particularly in cases with significant atherosclerotic plaque build-up in the lower extremities.

What outcomes have been reported in clinical studies?

Studies have reported effective plaque reduction and improved blood flow in patients with PAD, with successful initial use in European centers.

What complications have been reported?

Safety data from studies is limited, but potential complications include arterial dissection and embolization, common to atherectomy 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.

📬 Stay Updated

Get the latest vascular education content delivered to your inbox.