Diamondback 360 Peripheral Orbital Atherectomy System Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series Stealth 360 Peripheral Orbital Atherectomy System
FDA Clearance Information
The Diamondback 360 Peripheral Orbital Atherectomy System was cleared via the FDA 510(k) pathway on November 19, 2020. It is manufactured by Cardiovascular Systems and classified as a Class 2 device.
What It Is
FDA-Cleared Indications
- Treatment of stenotic lesions in peripheral arteries.
- Modification of calcified plaque before balloon angioplasty or other endovascular treatment.
- Use in peripheral vessels within the size and access limits specified in the device labeling.
Clinical Applications
- Plaque modification in calcified peripheral arterial disease.
- Preparation of peripheral arterial lesions before balloon angioplasty.
- Treatment planning for stenotic lesions in the lower-extremity peripheral arteries when atherectomy is indicated.
- Use with compatible guidewires, sheaths, and ancillary devices according to the system instructions for use.
Reported off-label uses
- Use in selected heavily calcified vascular access lesions to facilitate access for another procedure, such as transcatheter aortic valve replacement, when performed by an experienced team.
- Use in selected critical limb ischemia cases beyond the exact labeled lesion or vessel parameters.
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 system includes different catheter configurations and sizes, including exchangeable and Stealth 360 series options; the selected catheter must match the vessel diameter, lesion location, and access route specified in the labeling.
- The device is advanced over a compatible guidewire through a vascular sheath and operated under fluoroscopic imaging by trained clinicians.
- It is generally used with local anesthesia and may be combined with moderate sedation, depending on the access site and overall procedure.
- Potential complications include vessel dissection, perforation, thrombosis, distal embolization, spasm, bleeding, and need for additional treatment; contraindications and warnings in the current instructions for use apply.
- MRI safety depends on the specific system components and whether any device remains in the patient. The current manufacturer labeling should be checked before MRI; an atherectomy catheter is normally removed after treatment.
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 Peripheral Orbital Atherectomy System?
The device is indicated for plaque modification in peripheral arterial disease, particularly in cases with significant calcification, and is used in critical limb ischemia and optimizing TAVR access.
What outcomes have been reported in clinical studies?
Studies report effective revascularization in peripheral artery disease and critical limb ischemia, with improved access for TAVR procedures and potential cost benefits when used with balloon angioplasty.
What complications have been reported?
Safety data indicate complications such as guidewire fracture, vessel injury, and bleeding, particularly in complex cases requiring alternative access strategies.