📋 FDA Reference
Turbo-Power 2 0mm Laser Atherectomy Catheters Turbo-Power 2 3mm Laser Atherectomy Catheters
Summary: The Turbo-Power 2.0mm and 3.0mm laser atherectomy catheters by Spectranetics are used for removing atherosclerotic plaque in peripheral arteries. They are primarily used by vascular specialists in interventional procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K172687 ↗
Decision Date ?
November 27, 2017
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
0 studies
The Turbo-Power laser atherectomy catheters were cleared via the FDA 510(k) pathway on November 27, 2017. 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 plaque from peripheral arteries using laser technology. They operate by emitting laser energy to ablate and vaporize atherosclerotic blockages, restoring blood flow. These catheters are available in 2.0mm and 3.0mm sizes, allowing for flexibility in treating different vessel sizes.
FDA-Cleared Indications
- Removal of atherosclerotic plaque from peripheral arteries.
- Use during endovascular treatment of peripheral arterial disease when plaque removal is indicated.
Clinical Applications
- Laser atherectomy of atherosclerotic lesions in peripheral arteries.
- Plaque removal during catheter-based revascularization procedures for peripheral arterial disease.
- Treatment of peripheral arterial stenosis or occlusion when the device is appropriate for the target vessel and lesion.
- Use with standard peripheral endovascular access equipment and guidewires according to the device labeling.
Practical Considerations
- The device is available in 2.0 mm and 3.0 mm catheter sizes; selection depends on the target vessel and lesion anatomy.
- The procedure requires fluoroscopic imaging, guidewire access, and laser atherectomy equipment in an appropriately equipped vascular or interventional suite.
- Operators should be trained in peripheral laser atherectomy, including controlled advancement, energy delivery, and management of embolic or vessel-injury complications.
- MRI safety should be confirmed from the current device labeling and institutional policy before an examination; do not assume the catheter is safe while it remains in the body.
- Contraindications, warnings, and compatibility requirements should be checked in the current manufacturer instructions for use, including requirements for guidewires, sheaths, and laser-console settings.
Frequently Asked Questions
What is the Turbo-Power laser atherectomy catheter used for?
It is used for removing atherosclerotic plaque from peripheral arteries to restore blood flow.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly 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, particularly for patients with 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.