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turbo-power 2 0mm laser atherectomy catheters turbo-power 2 3mm laser atherectomy catheters
Spectranetics
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
510K
Number
K172687 ↗
Decision Date
November 27, 2017
Product Code
MCW
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.
Clinical Applications
These catheters are commonly used in interventional cardiology and vascular surgery settings, particularly for patients with peripheral artery disease (PAD). They are employed in endovascular procedures to treat stenotic or occluded peripheral arteries, often in the lower extremities. The devices are suitable for use in outpatient or hospital settings, providing a less invasive alternative to traditional surgical methods.
Indications for Use
The FDA-cleared indications for these devices include the removal of atherosclerotic plaque in peripheral arteries. They are intended for patients with PAD who require revascularization to improve blood flow and alleviate symptoms such as claudication.
Practical Considerations
The Turbo-Power catheters are available in two sizes, 2.0mm and 3.0mm, to accommodate different vessel diameters. They are compatible with standard guidewires and sheaths used in peripheral interventions. Clinicians should be trained in laser atherectomy techniques to ensure optimal outcomes and minimize complications.
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.