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diamondback 360 coronary orbital atherectomy device oad orbital atherectomy system pump oas pump viperwire advance c

Cardiovascular Systems

Summary: The Diamondback 360 Coronary Orbital Atherectomy Device is used for treating severely calcified coronary lesions. It is FDA-cleared and supported by 15 studies highlighting its safety and efficacy in clinical settings.

FDA Clearance Information

Pathway PMA
Number P130005 ↗
Decision Date April 10, 2019
Product Code MCX
Device Class Class 3
Evidence 19 studies

The Diamondback 360 Coronary Orbital Atherectomy Device was cleared through the FDA PMA pathway on April 10, 2019. Manufactured by Cardiovascular Systems, it is classified as a Class 3 device.

What It Is

The Diamondback 360 is an orbital atherectomy system designed to treat severely calcified coronary lesions. It operates by sanding away plaque using a diamond-coated crown, facilitating stent placement in percutaneous coronary interventions.

Clinical Applications

This device is commonly used in patients undergoing percutaneous coronary intervention (PCI) where severe calcification is present, which can impede stent deployment and expansion. It is particularly useful in complex coronary artery disease cases.

Evidence Summary

The available literature includes 15 studies, comprising randomized controlled trials and observational studies, conducted between 2022 and 2023. These studies evaluate the device's efficacy and safety in real-world and clinical trial settings.

Reported Outcomes

Published studies report that the Diamondback 360 is effective in preparing calcified coronary lesions for stent placement, reducing procedural complications associated with stent underexpansion. The device has shown positive outcomes in both clinical trials and real-world applications.

Safety Profile

Reported complications include procedural failure and access site complications, although these are minimized with the use of less invasive guiding catheters. Overall, the device has a favorable safety profile in the studies reviewed.

Evidence Limitations

Current evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to establish definitive long-term outcomes and to explore the device's efficacy across diverse patient populations.

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?

The device is indicated for the treatment of severely calcified coronary lesions to facilitate stent placement during percutaneous coronary intervention.

What outcomes have been reported in clinical studies?

Studies report effective lesion preparation and reduced procedural complications, with positive outcomes in both clinical trials and real-world settings.

What complications have been reported?

Reported complications include procedural failure and access site complications, though these are generally minimized with appropriate technique.

Related Device Categories

Atherectomy Devices
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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