đź“Š Evidence-Based Reference
Modification to Diamondback 360 Degree Orbital Atherectomy System
Cardio Systems
Summary: The Diamondback 360 Orbital Atherectomy System by Cardio Systems is used for treating peripheral arterial disease. Key evidence includes its initial use in Europe and treatment of lower extremity vascular disease.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K081944 ↗
Decision Date ?
August 14, 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 via the 510(k) pathway on August 14, 2008. It is manufactured by Cardio Systems and is classified as a Class 2 device.
What It Is
The Diamondback 360 Orbital Atherectomy System is a device designed to remove atherosclerotic plaque from peripheral arteries. It uses a diamond-coated crown that rotates at high speeds to sand away plaque, improving blood flow.
FDA-Cleared Indications
- Treatment of peripheral arterial disease caused by atherosclerotic plaque in peripheral arteries.
- Removal or modification of stenotic or obstructive plaque to facilitate restoration of blood flow.
- Use during percutaneous endovascular treatment of diseased peripheral vessels, as specified by the device labeling.
Clinical Applications
- Orbital atherectomy of plaque in lower-extremity peripheral arteries.
- Treatment of calcified or otherwise difficult-to-cross peripheral arterial lesions before or during balloon angioplasty.
- Plaque modification to help prepare a peripheral artery for subsequent endovascular treatment.
- Treatment of peripheral arterial narrowing associated with symptoms such as exertional leg pain or reduced limb perfusion.
Evidence Summary
The available literature includes two studies: one from 2008 and another from 2023. These studies encompass various methodologies, including prospective and retrospective analyses, focusing on the device's application in lower extremity vascular disease.
Reported Outcomes
Published studies report that the Diamondback 360 Orbital Atherectomy System effectively reduces plaque in peripheral arteries, improving blood flow and alleviating symptoms of PAD. The 2023 study highlights its successful initial use in a European tertiary center.
Safety Profile
Reported complications include typical risks associated with atherectomy procedures, such as arterial dissection and embolization. However, specific safety data from the provided studies is limited.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed safety outcomes. Further research is needed to establish long-term efficacy and safety, as well as to explore its use in diverse patient populations.
Practical Considerations
- The system is delivered through a vascular sheath and catheter under fluoroscopic imaging; the access site is commonly the common femoral artery, although other access routes may be selected by the treating physician.
- Vessel diameter, lesion length, degree of calcification, guidewire compatibility, and the labeled operating technique must be confirmed before use.
- The device is generally used with anticoagulation and careful control of treatment time and speed to reduce the risk of embolization, vessel injury, perforation, dissection, or thrombosis.
- MRI safety depends on the specific system components and whether they remain in the patient; the current device labeling should be checked before MRI.
- It is not appropriate for every lesion or patient, including some cases of severe access-vessel disease, inability to receive required antithrombotic treatment, or contraindication to angiography and endovascular therapy.
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?
The device is indicated for the treatment of peripheral arterial disease, particularly in cases with significant atherosclerotic plaque build-up in the lower extremities.
What outcomes have been reported in clinical studies?
Studies have reported effective plaque reduction and improved blood flow in patients with PAD, with successful initial use in European centers.
What complications have been reported?
Safety data from studies is limited, but potential complications include arterial dissection and embolization, common to atherectomy 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.