đź“Š Evidence-Based Reference
Diamondback 360 Peripheral Orbital Atherectomy System Stealth 360 Peripheral Orbital Atherectomy System Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
Cardiovascualr Systems
Summary: The Diamondback 360 Peripheral Orbital Atherectomy System is used for plaque modification in peripheral artery disease. Key evidence highlights its role in facilitating revascularization and addressing calcified lesions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K220568 ↗
Decision Date ?
April 27, 2022
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
19 studies
The Diamondback 360 Peripheral Orbital Atherectomy System was cleared by the FDA via the 510(k) pathway on April 27, 2022. It is manufactured by Cardiovascular Systems and is classified as a Class 2 device.
What It Is
The Diamondback 360 Peripheral Orbital Atherectomy System is a device designed to modify plaque in peripheral arteries, particularly in cases of arterial calcification. It uses an orbital mechanism to ablate calcified lesions, facilitating subsequent revascularization procedures.
FDA-Cleared Indications
- The system is indicated for atherectomy of stenotic peripheral blood vessels.
- It is intended to modify atherosclerotic plaque in peripheral arteries before or during endovascular treatment.
- The device is used in vessels appropriate for the labeled catheter and guidewire configuration, according to the cleared device instructions for use.
Clinical Applications
- Plaque modification in calcified peripheral arterial lesions before balloon angioplasty.
- Treatment preparation for peripheral endovascular revascularization in patients with peripheral artery disease.
- Atherectomy of stenotic lesions in lower-extremity peripheral arteries within the device's labeled vessel-size range.
- Modification of plaque when arterial calcium limits balloon expansion or passage of other treatment devices.
Evidence Summary
The available literature includes 7 studies, comprising various study types such as retrospective analyses and case series, published between 2015 and 2020. These studies explore the device's clinical applications and economic impact.
Reported Outcomes
Published studies report that the Diamondback 360 system effectively facilitates revascularization in patients with peripheral artery disease and critical limb ischemia. It has been shown to optimize vascular access in complex cases and may reduce the need for alternative access strategies.
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
The evidence is limited by the lack of large-scale randomized controlled trials and the predominance of retrospective analyses. Further research is needed to systematically evaluate long-term outcomes and safety profiles.
Practical Considerations
- The system is available in catheter configurations with different treatment profiles and vessel-size applications; the operator must select the size specified in the current instructions for use.
- The device is used over a compatible guidewire through an arterial introducer sheath, with fluoroscopic imaging and controlled orbital motion.
- It is generally used with local anesthesia and moderate sedation, although anesthesia needs vary by patient and procedure.
- MRI safety depends on the specific device component and whether it remains in the body; the system should be removed before MRI unless the current labeling specifically identifies the component as MR safe or MR conditional.
- Contraindications and precautions include unsuitable vessel anatomy, inability to cross the lesion with the required wire, acute thrombus or dissection, and failure to maintain appropriate wire position. The current manufacturer labeling should be reviewed before use.
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 Peripheral Orbital Atherectomy System?
The device is indicated for plaque modification in peripheral artery disease, particularly in cases with significant arterial calcification.
What outcomes have been reported in clinical studies?
Studies have reported successful facilitation of revascularization and improved access for procedures like TAVR in patients with calcified lesions.
What complications have been reported?
Safety data indicate potential complications such as guidewire fractures during the procedure, as documented in the MAUDE database.
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.