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diamondback 360 degree orbital atherectomy system for treatment of a-v shunt stenosis

Cardiovascular Systems

Summary: The Diamondback 360 Orbital Atherectomy System is designed for the treatment of a-v shunt stenosis. It is FDA-cleared and supported by multiple studies highlighting its efficacy and safety in treating calcified lesions.

FDA Clearance Information

Pathway 510K
Number K071427 ↗
Decision Date August 30, 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 30, 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 minimally invasive device used to treat stenosis in arteriovenous shunts. It operates by orbiting a diamond-coated crown to sand away plaque, improving blood flow.

Clinical Applications

This device is commonly used in clinical settings to manage a-v shunt stenosis and peripheral arterial disease, particularly in cases involving calcified lesions. It is utilized in both coronary and peripheral vascular interventions.

Evidence Summary

The literature includes six studies, ranging from 2008 to 2023, comprising randomized controlled trials and observational studies. These studies evaluate the device's efficacy and safety in treating calcified lesions.

Reported Outcomes

Published studies report favorable procedural outcomes with the Diamondback 360, including improved blood flow and reduced stenosis in treated vessels. Optical coherence tomography imaging has shown effective ablation of calcified lesions.

Safety Profile

Reported complications include potential vascular injury and embolization, though these are generally infrequent. The device's safety profile is considered acceptable based on current evidence.

Evidence Limitations

Current evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to fully understand the long-term efficacy and safety of the device 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 System?

The device is indicated for the treatment of a-v shunt stenosis and calcified lesions in peripheral and coronary arteries.

What outcomes have been reported in clinical studies?

Studies have reported improved blood flow and reduced stenosis, with favorable procedural outcomes.

What complications have been reported?

Safety data indicate potential complications such as vascular injury and embolization, though these are infrequent.

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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