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orbital atherectomy system for treatment of a-v shunt stenosis
Cardiovascular Systems
Summary: The orbital atherectomy system is a device used primarily for treating a-v shunt stenosis. Key evidence highlights its efficacy in successful stent delivery and safety in calcified coronary lesions.
FDA Clearance Information
Pathway
510K
Number
K041630 ↗
Decision Date
January 31, 2005
Product Code
MCW
Device Class
Class 2
Evidence
0 studies
The orbital atherectomy system by Cardiovascular Systems was cleared by the FDA via the 510(k) pathway on January 31, 2005. It is classified as a Class 2 medical device.
What It Is
The orbital atherectomy system is designed to remove calcified plaque from blood vessels, particularly in the context of a-v shunt stenosis. It uses a rotating crown mechanism to ablate calcified lesions, facilitating subsequent interventions like stent placement.
Clinical Applications
This device is commonly used in scenarios involving heavily calcified coronary lesions where traditional balloon angioplasty may be insufficient. It is particularly useful in preparing vessels for stent implantation by modifying calcified plaques.
Evidence Summary
The literature includes 15 studies, encompassing randomized controlled trials, prospective and retrospective analyses, and case series. These studies span from 2021 to 2025, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the orbital atherectomy system achieves a high rate of successful stent delivery, with one study noting a success rate of 97.7%. Additionally, the 30-day major adverse cardiac event (MACE) rate was reported at 10.4% in one comparative study.
Safety Profile
Reported complications include potential tip rupture of the device, as noted in some studies. However, a multicenter analysis found no significant differences in 1-year MACE rates, suggesting a favorable safety profile.
Evidence Limitations
The evidence base is limited by the variability in study designs and patient populations. Further research is needed to establish long-term outcomes and to compare the device's efficacy directly with other atherectomy techniques in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for the orbital atherectomy system?
The device is indicated for the treatment of calcified coronary lesions, particularly in cases where traditional methods are inadequate.
What outcomes have been reported in clinical studies?
Clinical studies have reported a high success rate in stent delivery and a 30-day MACE rate of 10.4%.
What complications have been reported?
Safety data indicate potential complications such as tip rupture, but overall, no significant differences in 1-year MACE rates have been observed.
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.