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spectranetics turbo-elite laser atherectomy catheters
Spectranetics
Summary: The Spectranetics Turbo-Elite Laser Atherectomy Catheters are used for atherectomy procedures, primarily in treating peripheral artery disease. Key evidence includes studies assessing the device's impact on arterial walls and its efficacy in treating femoro-popliteal lesions.
FDA Clearance Information
Pathway
510K
Number
K170059 ↗
Decision Date
April 7, 2017
Product Code
MCW
Device Class
Class 2
Evidence
0 studies
The Spectranetics Turbo-Elite Laser Atherectomy Catheters were cleared by the FDA via the 510(k) pathway on April 7, 2017. Manufactured by Spectranetics, the device is classified as a Class 2 medical device under product code MCW.
What It Is
The Spectranetics Turbo-Elite Laser Atherectomy Catheters are designed to remove atherosclerotic plaque from peripheral arteries using laser energy. The device is intended for use in endovascular procedures to treat peripheral artery disease, particularly in the femoro-popliteal region.
Clinical Applications
Common clinical scenarios for the use of this device include the treatment of peripheral artery disease, especially in cases involving the superficial femoral artery and proximal popliteal artery. It is often used in patients with in-stent restenosis or complex lesions.
Evidence Summary
The available literature includes five studies, comprising randomized controlled trials and registry analyses, conducted between 2018 and the present. These studies assess the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the Spectranetics Turbo-Elite Laser Atherectomy Catheters effectively enlarge lumen openings and treat femoro-popliteal lesions. The device has shown promise in reducing restenosis rates when used in conjunction with other therapies, such as paclitaxel-coated balloons.
Safety Profile
Reported complications include dissections in the vessel wall following treatment, as assessed by intravascular ultrasound. The safety profile is consistent with other atherectomy devices, with no new safety concerns identified in the reviewed studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of long-term follow-up data. Further research is needed to establish the device's long-term efficacy and safety, as well as its performance in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Spectranetics Turbo-Elite Laser Atherectomy Catheters?
The device is indicated for the treatment of peripheral artery disease, particularly in the femoro-popliteal region, and is used to remove atherosclerotic plaque from peripheral arteries.
What outcomes have been reported in clinical studies?
Studies have reported effective lumen enlargement and reduced restenosis rates when the device is used in conjunction with other therapies.
What complications have been reported?
Safety data indicate that complications may include dissections in the vessel wall, as observed through intravascular ultrasound.
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.