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B-Laser Atherectomy System
Product: Auryon Atherectomy Catheter 1.5 mm OTW — all models and sizes
Summary: The B-Laser Atherectomy System by Eximo Medical is a laser-based device used for peripheral atherectomy. It is primarily used for treating infrainguinal peripheral artery disease (PAD). Key evidence suggests its effectiveness in managing arterial dissections with minimal flow limitations.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K181642 ↗
Decision Date ?
October 5, 2018
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
0 studies
The B-Laser Atherectomy System was cleared by the FDA via the 510(k) pathway on October 5, 2018. It is manufactured by Eximo Medical and classified as a Class 2 medical device under product code MCW.
What It Is
The B-Laser Atherectomy System is a 355 nm solid-state Nd:YAG short pulse laser designed for atherectomy procedures. It is intended for the removal of atheroma and calcified plaque in infrainguinal peripheral artery disease (PAD). The device offers enhanced precision and safety in vascular interventions.
FDA-Cleared Indications
- Removal of atheroma and calcified plaque in infrainguinal peripheral arteries.
- Treatment of peripheral artery disease lesions in the lower-extremity arterial circulation.
- Use in de novo and restenotic infrainguinal lesions when atherectomy is clinically indicated.
Clinical Applications
- Laser atherectomy of plaque in infrainguinal peripheral arteries.
- Treatment of de novo lower-extremity arterial lesions associated with peripheral artery disease.
- Treatment of restenotic infrainguinal lesions after prior endovascular treatment.
- Plaque modification before or during lower-extremity endovascular revascularization when removal of atheroma is indicated.
Evidence Summary
The available literature includes five studies, comprising randomized controlled trials, prospective and retrospective analyses, and registry data. These studies span from 2018 to 2022, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the B-Laser Atherectomy System effectively manages arterial dissections with minimal flow limitations. The device has shown a high affinity for atheroma and calcified plaque, contributing to improved outcomes in infrainguinal PAD treatment.
Safety Profile
Reported complications include infrequent and non-flow limiting femoropopliteal arterial dissections. The safety profile of the device is generally favorable, with no significant adverse events reported in the available studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to fully understand the long-term safety and efficacy of the B-Laser Atherectomy System in diverse patient populations.
Practical Considerations
- The system uses a 355-nm short-pulse laser and is intended for use with compatible atherectomy catheters and accessories according to the manufacturer’s instructions.
- Device selection depends on lesion location, vessel diameter, lesion length, plaque characteristics, access anatomy and the catheter’s labeled size range.
- Use requires fluoroscopic or other appropriate imaging guidance, vascular access, and operators trained in peripheral endovascular intervention and laser safety.
- MRI safety should be determined from the current device labeling for the specific catheter and generator; do not assume the system is MRI safe while any component is implanted or retained.
- Important risks include vessel perforation or dissection, distal embolization, thrombosis, bleeding at the access site, arterial spasm, restenosis, contrast-related complications and the possible need for additional treatment.
Frequently Asked Questions
What are the clinical indications for B-Laser Atherectomy System?
The B-Laser Atherectomy System is indicated for the treatment of infrainguinal peripheral artery disease, particularly in cases involving atheroma and calcified plaque.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective management of arterial dissections with minimal flow limitations and a high affinity for plaque removal.
What complications have been reported?
Safety data from evidence indicate infrequent and non-flow limiting femoropopliteal arterial dissections as the primary complication.
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.