đź“Š Evidence-Based Reference
turbo-elite laser atherectomy catheter
Spectranetics
Summary: The Turbo-Elite Laser Atherectomy Catheter is a device used for atherectomy procedures, primarily in peripheral artery disease. Key evidence highlights its application in endovascular treatments with a focus on safety and efficacy.
FDA Clearance Information
Pathway 510K
Number K250385 ↗
Decision Date March 13, 2025
Product Code MCW
Device Class Class 2
Evidence 0 studies
The Turbo-Elite Laser Atherectomy Catheter received FDA 510(k) clearance on March 13, 2025. Manufactured by Spectranetics, it is classified as a Class 2 medical device.
What It Is
The Turbo-Elite Laser Atherectomy Catheter is designed to remove atherosclerotic plaque from blood vessels using laser technology. It is intended for use in peripheral artery disease to improve blood flow by excising plaque.
Clinical Applications
Commonly used in the treatment of peripheral artery disease, the Turbo-Elite Laser Atherectomy Catheter is applied in scenarios requiring precise plaque removal, such as in the femoro-popliteal arteries.
Evidence Summary
The literature includes 6 studies ranging from 2018 to 2024, encompassing various study types such as RCTs and prospective analyses. These studies provide insights into the device's clinical applications and outcomes.
Reported Outcomes
Published studies report that the Turbo-Elite Laser Atherectomy Catheter effectively enlarges lumen openings and facilitates endovascular treatments. The device has shown efficacy in reducing restenosis rates when combined with other interventions.
Safety Profile
Reported complications include vessel wall dissections observed via intravascular ultrasound. The studies highlight the importance of careful application to minimize adverse events.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for long-term follow-up studies. Further research is required to fully understand the long-term safety and efficacy of the device.
Frequently Asked Questions
What are the clinical indications for Turbo-Elite Laser Atherectomy Catheter?
The device is indicated for the removal of atherosclerotic plaque in peripheral artery disease, particularly in the femoro-popliteal arteries.
What outcomes have been reported in clinical studies?
Studies have reported effective lumen enlargement and reduced restenosis rates when used in conjunction with other treatments.
What complications have been reported?
Safety data indicate potential complications such as vessel wall dissections, emphasizing the need for precise application.
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.