Diamondback 360 Dbx
FDA Clearance Information
The Diamondback 360 DBX, manufactured by Cardiovascular Systems, was cleared through the FDA 510(k) pathway on March 20, 2009. It is a Class 2 medical device under product code MCW.
What It Is
FDA-Cleared Indications
- Removal of atherosclerotic plaque in peripheral arteries.
- Treatment of peripheral arterial lesions that may be difficult to treat with balloon angioplasty alone.
Clinical Applications
- Rotational atherectomy of atherosclerotic plaque in peripheral arteries.
- Plaque modification before or during balloon angioplasty.
- Treatment of calcified lesions in lower-extremity peripheral arteries when plaque modification is clinically appropriate.
- Use in catheter-based peripheral arterial interventions performed over a guidewire.
Practical Considerations
- The device is used under fluoroscopic imaging by clinicians trained in peripheral rotational atherectomy.
- Appropriate device size and treatment technique depend on the target vessel diameter, lesion characteristics and guidewire compatibility.
- It is a single-use catheter system; follow the current manufacturer instructions for preparation, rotational speed, treatment time and flushing.
- MRI safety should be confirmed in the current device labeling. Do not assume that the device or any retained component is MR safe or MR conditional.
- Contraindications, warnings and precautions include factors such as unsuitable vessel anatomy, inability to cross the lesion safely, thrombus or dissection; the current FDA-cleared labeling should be reviewed before use.
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 is Diamondback 360 DBX used for?
The Diamondback 360 DBX is used for removing plaque from peripheral arteries, particularly in patients with calcified lesions.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use the Diamondback 360 DBX.
What are the FDA-cleared indications?
The device is indicated for the removal of atherosclerotic plaque in peripheral arteries, especially in cases of calcified lesions.