Diamondback 360 Degree Orbital Atherectomy System for Treatment of A-V Shunt Stenosis
FDA Clearance Information
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
FDA-Cleared Indications
- Treatment of stenosis in arteriovenous shunts.
Clinical Applications
- Endovascular treatment of stenosis within an arteriovenous shunt used for hemodialysis access.
- Treatment of calcified or fibrotic narrowing in an A-V shunt when plaque modification is needed to improve lumen expansion.
- Orbital atherectomy during a percutaneous intervention before adjunctive balloon angioplasty or other indicated treatment.
Reported off-label uses
- Treatment of calcified peripheral arterial lesions outside the labeled A-V shunt indication.
- Plaque modification in coronary arteries or other vascular beds, depending on the specific device model, labeling and clinical setting.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- The catheter must be compatible with the guidewire, sheath, access route and target-vessel diameter specified in the current device labeling.
- Treatment is performed under fluoroscopic imaging, generally through percutaneous vascular access, and may be followed by balloon angioplasty or another access-circuit intervention.
- The rotating, diamond-coated crown requires careful handling and operation according to the instructions for use; excessive pressure or prolonged treatment in one location can increase the risk of vessel or shunt injury.
- MRI safety depends on the specific catheter and whether it remains in the patient. The current device labeling should be checked before MRI; do not assume the system is safe while implanted or retained.
- Contraindications, warnings and access-circuit limitations should be reviewed in the current manufacturer labeling. Possible complications include bleeding, vessel injury, thrombosis, embolization and loss of shunt function.
Linked Studies (19)
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 →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 →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 →Coronary orbital atherectomy using a five-French guiding catheter.
Cardiovascular intervention and therapeutics
View Source →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 →Orbital atherectomy for calcified femoropopliteal lesions: a current review.
The Journal of cardiovascular surgery
View Source →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 →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 →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 →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 →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 →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 →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 →Orbital atherectomy: device evolution and clinical data.
The Journal of invasive cardiology
RCT|prospective|retrospective|case Series|other View Source →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 →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 →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 →Use and abuse of atherectomy: where should it be used?
Seminars in vascular surgery
RCT|prospective|retrospective|case Series|other View Source →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.