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Diamondback 360 Degree Orbital Atherectomy System with Viperslide Lubricant
Summary: The Diamondback 360 Orbital Atherectomy System is a device used for atherectomy in calcified coronary and peripheral arterial lesions. Key evidence highlights its efficacy in improving blood flow in severely calcified lesions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K082981 ↗
Decision Date ?
October 31, 2008
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
19 studies
The Diamondback 360 Orbital Atherectomy System was cleared by the FDA through the 510(k) pathway on October 31, 2008. It is manufactured by Cardiovascular Systems and is classified as a Class 2 medical device.
What It Is
The Diamondback 360 Orbital Atherectomy System is designed to remove atherosclerotic plaque from coronary and peripheral arteries. It uses a diamond-coated crown that rotates to sand away calcified plaque, facilitating improved blood flow.
FDA-Cleared Indications
- Treatment of de novo or restenotic calcified lesions in peripheral arteries, including the iliac, femoral, popliteal and infrapopliteal arteries.
- Treatment of stenotic lesions in native coronary arteries that are difficult to dilate because of calcification.
- Use with ViperSlide lubricant during operation of the orbital atherectomy system, according to the device labeling.
Clinical Applications
- Plaque modification in severely calcified peripheral arterial disease before angioplasty or stenting.
- Treatment of calcified lesions in the iliac, femoral, popliteal or below-the-knee arteries.
- Plaque modification in calcified native coronary artery lesions before balloon angioplasty or stent placement.
- Facilitation of balloon expansion when arterial calcium makes conventional angioplasty difficult.
Evidence Summary
The available literature includes randomized controlled trials, prospective and retrospective studies, and case series. The studies span from 2008 to 2023, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report favorable procedural outcomes with the Diamondback 360, including improved blood flow and reduced symptoms in patients with calcified lesions. Optical coherence tomography imaging has demonstrated effective plaque removal.
Safety Profile
Reported complications include potential vascular injury due to the mechanical action of the device. However, studies generally report a favorable safety profile with no significant increase in adverse events compared to other atherectomy devices.
Evidence Limitations
The evidence is limited by the small sample sizes in some studies and the lack of long-term follow-up data. Further research is needed to evaluate the long-term efficacy and safety of the device in diverse patient populations.
Practical Considerations
- The system includes a catheter with a diamond-coated orbital crown, a drive unit and ViperSlide lubricant; available catheter and crown configurations depend on the specific model and vascular territory.
- It is delivered over a guidewire through vascular access and used under fluoroscopic imaging. Correct guidewire, sheath and catheter compatibility must be confirmed before treatment.
- ViperSlide lubricant is required for the labeled system operation and should be used according to the instructions for use.
- The device is not a permanent implant and is removed after atherectomy. MRI considerations primarily relate to any other implanted device or retained material rather than to the removed catheter.
- Potential complications include vessel dissection or perforation, distal embolization, thrombosis, spasm, bleeding at the access site, arrhythmia during coronary treatment and kidney injury related to contrast. Contraindications and lesion-specific limitations should be reviewed in the current labeling.
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 patients with peripheral arterial disease and severely calcified coronary lesions to improve blood flow and reduce symptoms.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural success and blood flow in treated lesions, with favorable short-term outcomes.
What complications have been reported?
Safety data indicate potential vascular injury, but overall, the device has a favorable safety profile with no significant increase in adverse events.
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.