Viperwire Advance Guide Wire Diamondback 360 Peripheral Orbital Atherectomy System Stealth 360 Orbital Pad
Cardiovascular System
FDA Clearance Information
The ViperWire Advance Guide Wire was cleared through the FDA 510k pathway on June 10, 2015. Manufactured by Cardiovascular System, it is classified as a Class 2 device under product code MCW.
What It Is
FDA-Cleared Indications
- Treatment of peripheral arterial disease involving calcified plaque in peripheral arteries.
- Use with the Diamondback 360 Peripheral Orbital Atherectomy System to modify peripheral arterial lesions before or during endovascular treatment.
Clinical Applications
- Orbital atherectomy of calcified peripheral arterial lesions.
- Plaque modification before balloon angioplasty in peripheral arteries.
- Treatment of calcified lesions that may limit balloon expansion or impede other endovascular therapy.
- Endovascular treatment of peripheral arterial disease in a catheterization laboratory.
Practical Considerations
- The ViperWire Advance Guide Wire is used as part of the Diamondback 360 system; it is not a standalone plaque-removal device.
- The operator must select the appropriate wire, catheter, and treatment settings for the target vessel and lesion, following the device labeling and institutional protocols.
- The system requires fluoroscopic guidance and controlled advancement and withdrawal during orbital atherectomy.
- Potential complications include vessel dissection or perforation, distal embolization, thrombosis, spasm, bleeding at the access site, and renal injury related to contrast use.
- MRI safety depends on the specific wire and system configuration. The current device labeling and institutional MRI-safety guidance should be reviewed before MRI, rather than assuming the device is MR safe.
Related Literature
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 ViperWire Advance Guide Wire used for?
It is used to treat peripheral arterial disease by modifying calcified plaque in peripheral arteries.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for the treatment of calcified plaque in peripheral arteries in patients with peripheral arterial disease.