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Turbo-Power Laser Atherectomy Catheter
Product: Turbo-Power — all models and sizes
Summary: The Turbo-Power Laser Atherectomy Catheter by Spectranetics is a device used primarily for atherectomy procedures. Key evidence suggests improved outcomes when combined with drug-coated balloon angioplasty for femoropopliteal in-stent restenosis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K152181 ↗
Decision Date ?
November 12, 2015
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
0 studies
The Turbo-Power Laser Atherectomy Catheter was cleared by the FDA via the 510(k) pathway on November 12, 2015. It is manufactured by Spectranetics and classified as a Class 2 device.
What It Is
The Turbo-Power Laser Atherectomy Catheter is a medical device designed to remove atherosclerotic plaque from blood vessels. It uses laser technology to precisely ablate plaque, facilitating improved blood flow. It is intended for use in peripheral artery disease, particularly in the femoropopliteal arteries.
FDA-Cleared Indications
- Percutaneous excimer laser atherectomy of peripheral arterial lesions.
- Treatment of stenotic or occluded lesions in the peripheral vasculature that can be crossed with a guidewire.
- Use in conjunction with percutaneous transluminal angioplasty when clinically appropriate.
Clinical Applications
- Laser atherectomy of selected femoropopliteal artery lesions.
- Treatment of peripheral arterial plaque or obstructive tissue before balloon angioplasty.
- Treatment of selected femoropopliteal in-stent restenosis as part of an endovascular strategy.
- Lesion preparation before adjunctive balloon angioplasty, including drug-coated balloon treatment when otherwise appropriate.
Evidence Summary
The available literature includes four studies, with a mix of randomized controlled trials and other study types. These studies span from 2015 to 2021, focusing on the device's efficacy and safety in treating peripheral artery disease.
Reported Outcomes
Published studies report that the Turbo-Power Laser Atherectomy Catheter, when used with drug-coated balloon angioplasty, is associated with improved one-year outcomes for femoropopliteal in-stent restenosis. The combination therapy has shown superiority over conventional balloon angioplasty alone.
Safety Profile
Reported complications include typical risks associated with atherectomy procedures, such as vessel dissection and perforation. However, specific safety data from the provided studies are limited.
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 comprehensive safety profiles and to explore the device's efficacy in broader patient populations.
Practical Considerations
- The catheter must be advanced over a compatible guidewire through an appropriately sized vascular sheath; exact catheter diameter, working length and guidewire compatibility depend on the specific model.
- Treatment is performed under fluoroscopic imaging, commonly through femoral arterial access, with the laser activated according to the manufacturer's instructions for use.
- Laser atherectomy may require adjunctive balloon angioplasty and does not eliminate the risks of distal embolization, perforation, dissection, thrombosis or bleeding.
- MRI safety depends on the exact catheter model and whether the device remains in the body; the current product labeling should be checked before MRI.
- Contraindications, lesion-crossing requirements, laser settings, flushing requirements and vessel-size limits must be verified in the device-specific instructions for use.
Frequently Asked Questions
What are the clinical indications for turbo-power laser atherectomy catheter?
The device is indicated for the treatment of peripheral artery disease, specifically for femoropopliteal artery in-stent restenosis and de novo lesions.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved one-year outcomes when the device is used with drug-coated balloon angioplasty for femoropopliteal in-stent restenosis.
What complications have been reported?
Reported complications include vessel dissection and perforation, typical of atherectomy procedures, though specific data from the studies are limited.
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.