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viperwire advance guide wire stealth 360 orbital peripheral atherectomy device pad diamondback 360 peripheral atherectomy system

Cardiovascular Systems

Summary: The ViperWire Advance Guide Wire is used in conjunction with the Diamondback 360 Peripheral Atherectomy System for treating peripheral artery disease (PAD). It is primarily used by interventional cardiologists and vascular surgeons.

FDA Clearance Information

Pathway 510K
Decision Date April 17, 2018
Product Code MCW
Device Class Class 2
Evidence 19 studies

The ViperWire Advance Guide Wire, manufactured by Cardiovascular Systems, was cleared through the FDA 510(k) pathway on April 17, 2018. It is a Class 2 device under product code MCW.

What It Is

The ViperWire Advance Guide Wire is a specialized guide wire used in peripheral atherectomy procedures. It is designed to navigate through complex arterial lesions and facilitate the use of the Diamondback 360 Peripheral Atherectomy System. The device helps in the removal of plaque from peripheral arteries, improving blood flow and reducing symptoms of PAD.

Clinical Applications

This device is commonly used in interventional cardiology and vascular surgery settings, particularly for patients with peripheral artery disease. It is utilized in procedures aiming to restore blood flow in the peripheral arteries, such as those in the legs. The guide wire is essential for navigating through challenging arterial blockages and is often used in outpatient or hospital catheterization labs.

Indications for Use

The ViperWire Advance Guide Wire is indicated for use in patients with peripheral artery disease to assist in atherectomy procedures. It is suitable for patients with significant arterial blockages that require mechanical plaque removal.

Practical Considerations

The ViperWire Advance Guide Wire is compatible with the Diamondback 360 system and is available in various sizes to accommodate different anatomical needs. Clinicians should be familiar with the atherectomy technique and ensure proper wire handling to avoid complications.

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 is ViperWire Advance Guide Wire used for?

It is used to facilitate peripheral atherectomy procedures in patients with peripheral artery disease.

What specialties typically use this device?

Interventional cardiologists and vascular surgeons typically use this device.

What are the FDA-cleared indications?

The device is indicated for use in peripheral artery disease to assist in atherectomy procedures for plaque removal.

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.

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