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Modification to Diamondback 360 Orbital Atherectomy System
Summary: The Diamondback 360 Orbital Atherectomy System is a device used for plaque modification in calcified lesions. It is primarily used in peripheral and coronary artery disease. Key evidence highlights its efficacy in reducing calcification and improving vessel patency.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K072748 ↗
Decision Date ?
November 9, 2007
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
19 studies
The Diamondback 360 Orbital Atherectomy System was cleared by the FDA via the 510(k) pathway on November 9, 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 mechanical device designed to modify calcified plaque in arterial lesions. It operates through high-speed elliptical crown rotation, facilitating plaque modification in both peripheral and coronary arteries.
FDA-Cleared Indications
- Treatment of de novo, severely calcified lesions in peripheral arteries.
- Treatment of de novo, severely calcified coronary artery lesions.
- Plaque modification before balloon angioplasty or stent placement in appropriately selected lesions.
Clinical Applications
- Modification of calcified plaque in peripheral arterial disease during endovascular revascularization.
- Modification of calcified coronary plaque during percutaneous coronary intervention.
- Lesion preparation before balloon angioplasty in severely calcified arteries.
- Lesion preparation before coronary or peripheral stent placement when calcification limits balloon expansion or device delivery.
Reported off-label uses
- Use in selected heavily calcified lesions outside the specific anatomy, lesion characteristics, or indications described in the device labeling may be reported in clinical practice, but requires physician judgment and is not an FDA-cleared indication.
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
The available literature includes 11 studies, comprising various study types such as RCTs and observational studies, conducted between 2019 and 2025. These studies explore the device's efficacy and safety in different clinical settings.
Reported Outcomes
Published studies report that the Diamondback 360 Orbital Atherectomy System is effective in reducing calcification and improving vessel patency in both coronary and peripheral arteries. The device has demonstrated efficacy in treating calcified lesions, facilitating successful revascularization.
Safety Profile
Reported complications include guidewire fractures during procedures, as noted in the MAUDE database. These events, while not systematically studied, highlight the need for careful procedural planning and execution.
Evidence Limitations
Current evidence is limited by the lack of large-scale, randomized controlled trials. Most studies are observational or retrospective, which may introduce bias. Further research is needed to establish long-term outcomes and safety profiles.
Practical Considerations
- The system is delivered through a compatible guide catheter or sheath, and device selection depends on the target vessel, lesion location, vessel diameter, and access route.
- It requires fluoroscopic imaging and careful control of the device, including appropriate rotational speed, treatment duration, and advancement technique.
- Contraindications and warnings include inability to pass the guidewire across the lesion, significant dissection or perforation, acute thrombosis, and other conditions listed in the current instructions for use.
- The system is not an implant and does not remain in the body after the procedure; MRI considerations generally apply to any retained stent or other implanted device placed during the treatment, not to the removed atherectomy catheter.
- Atherectomy can cause distal embolization, vessel injury, perforation, slow or no-reflow, spasm, thrombosis, bleeding, or the need for additional treatment.
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 use in modifying calcified plaque in coronary and peripheral artery lesions.
What outcomes have been reported in clinical studies?
Studies have reported improved vessel patency and reduced calcification in treated lesions.
What complications have been reported?
Safety data indicate potential complications such as guidewire fractures during procedures.
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.