đź“‹ FDA Reference
Turbo-Power 2 0mm Laser Atherectomy Catheters
Product: Turbo-Power — all models and sizes
Summary: The Turbo-Power 2.0mm Laser Atherectomy Catheters are used for removing atherosclerotic plaque from peripheral arteries. Interventional cardiologists and vascular surgeons typically use this device in endovascular procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K162561 ↗
Decision Date ?
January 5, 2017
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
0 studies
The Turbo-Power 2.0mm Laser Atherectomy Catheters were cleared via the FDA 510k pathway on January 5, 2017. Manufactured by Spectranetics, this device is classified as a Class 2 medical device under product code MCW.
What It Is
The Turbo-Power 2.0mm Laser Atherectomy Catheters are minimally invasive tools designed to remove plaque from peripheral arteries using laser technology. The device utilizes a laser to precisely ablate atherosclerotic material, improving blood flow. It is particularly useful in treating peripheral artery disease (PAD) and is designed for use in the femoral, popliteal, and other peripheral arteries.
FDA-Cleared Indications
- Removal of atherosclerotic plaque from peripheral arteries.
- Use in patients who require endovascular treatment to improve blood flow through diseased peripheral arteries.
Clinical Applications
- Laser atherectomy of atherosclerotic disease in peripheral arteries.
- Treatment of peripheral arterial blockages during catheter-based revascularization.
- Treatment of lower-extremity peripheral artery disease involving vessels such as the femoral or popliteal arteries.
- Plaque removal in a catheterization laboratory or vascular procedure suite before or as part of additional endovascular treatment.
Practical Considerations
- The catheter has a nominal 2.0 mm treatment diameter and must be selected to match the target vessel and lesion.
- The device is used over a compatible guidewire and with fluoroscopic imaging by clinicians trained in laser atherectomy.
- Treatment may be followed by balloon angioplasty, stent placement, or other revascularization, depending on the lesion and vessel response.
- The FDA record provided does not establish MRI safety; MRI compatibility should be confirmed in the current device labeling before scanning.
- As with other peripheral atherectomy devices, use requires assessment of vessel size, lesion characteristics, distal embolization risk, perforation risk, and other contraindications in the instructions for use.
Frequently Asked Questions
What is Turbo-Power 2.0mm Laser Atherectomy Catheters used for?
It is used to remove atherosclerotic plaque from peripheral arteries, improving blood flow in patients with peripheral artery disease.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for the removal of atherosclerotic plaque in peripheral arteries to treat peripheral artery disease.
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.