Diamondback Spinal System
Eminent Spine
FDA Clearance Information
The Diamondback Spinal System received FDA clearance through the 510(k) pathway on April 22, 2010. It is manufactured by Eminent Spine and classified as a Class 2 device under product code MNI.
What It Is
FDA-Cleared Indications
- Spinal stabilization in patients requiring surgical treatment of spinal abnormalities.
- Use with spinal fusion procedures to help maintain alignment and immobilize vertebral segments.
- Treatment of spinal conditions such as degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformity, or traumatic spinal instability when surgical stabilization is indicated.
Clinical Applications
- Posterior spinal fixation during lumbar or thoracic spinal fusion.
- Stabilization of vertebral segments affected by degenerative disease when fusion is planned.
- Support of spinal alignment in selected cases of spondylolisthesis or spinal deformity.
- Internal fixation after traumatic spinal instability when the surgeon determines that stabilization is needed.
Practical Considerations
- The system includes components in different sizes and configurations to match the patient's anatomy and the planned spinal construct.
- Implantation requires specialized instruments and familiarity with the manufacturer's surgical technique.
- The device is generally used with bone graft and spinal fusion techniques; it does not by itself create a solid fusion.
- MRI safety depends on the exact implanted components and the manufacturer's current labeling. The implant card and device-specific MRI conditions should be reviewed before scanning.
- Contraindications and precautions may include active infection, inadequate bone quality, allergy to implant materials, or inability to follow postoperative restrictions; the treating surgeon makes the final determination.
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 the Diamondback Spinal System used for?
It is used for spinal stabilization in surgeries to treat conditions like degenerative disc disease and spinal deformities.
What specialties typically use this device?
Orthopedic surgeons and neurosurgeons commonly use this device in spinal surgeries.
What are the FDA-cleared indications?
The device is indicated for spinal stabilization in patients with conditions such as degenerative disc disease and spinal deformities.