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Turbo-Power 2 0mm Laser Atherectomy Catheters Turbo-Power 2 3mm Laser Atherectomy Catheters
Product: Turbo-Power Laser Atherectomy Catheter — all models and sizes
Summary: The Turbo-Power 2.0mm and 3.0mm laser atherectomy catheters are used for the removal of atherosclerotic plaque in peripheral arteries. They are typically used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K222837 ↗
Decision Date ?
December 8, 2022
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
0 studies
The Turbo-Power laser atherectomy catheters were cleared through the FDA 510(k) pathway on December 8, 2022. Manufactured by Spectranetics, these devices are classified as Class 2 under product code MCW.
What It Is
The Turbo-Power laser atherectomy catheters are minimally invasive devices designed to remove atherosclerotic plaque from peripheral arteries. Utilizing laser technology, these catheters ablate plaque by delivering controlled laser energy. This helps to restore blood flow and improve vessel patency. The devices are available in 2.0mm and 3.0mm sizes to accommodate different vessel diameters.
FDA-Cleared Indications
- Treatment of atherosclerotic lesions in peripheral arteries.
- Removal or reduction of peripheral arterial plaque to improve vessel lumen and blood flow.
Clinical Applications
- Laser atherectomy of atherosclerotic lesions in peripheral arteries.
- Endovascular treatment of peripheral arterial disease involving lower-extremity arteries.
- Plaque modification before or with other endovascular treatments, when consistent with the device labeling and physician judgment.
- Treatment of peripheral arterial blockages for which plaque removal is clinically indicated.
Practical Considerations
- The catheters are available in 2.0 mm and 3.0 mm sizes; the appropriate size depends on the treated vessel and lesion.
- Use requires a compatible laser console, guidewire access, fluoroscopic imaging, and clinicians trained in laser atherectomy.
- The device is intended for peripheral arteries and should not be assumed to be cleared for coronary, cerebral, or other vascular applications.
- MRI safety information should be confirmed in the current device labeling before scanning; the catheter is generally removed before MRI.
- Contraindications, warnings, laser settings, vessel preparation, and the need for adjunctive balloon angioplasty or stenting should be reviewed in the current instructions for use.
Frequently Asked Questions
What is the Turbo-Power laser atherectomy catheter used for?
It is used for the removal of atherosclerotic plaque in peripheral arteries to restore blood flow.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for the treatment of atherosclerotic lesions in peripheral arteries to restore adequate blood flow.
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.