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modified ivt peripheral atherectomy
Intensive Technology
Summary: The modified IVT peripheral atherectomy device is used to remove plaque from peripheral arteries. It is typically used by interventional cardiologists and vascular surgeons to treat peripheral artery disease.
FDA Clearance Information
Pathway
510K
Number
K901767 ↗
Decision Date
June 28, 1990
Product Code
LIT
Device Class
Class 2
Evidence
0 studies
The modified IVT peripheral atherectomy device by Intensive Technology was cleared through the FDA 510(k) pathway on June 28, 1990. It is classified as a Class 2 medical device under product code LIT.
What It Is
The modified IVT peripheral atherectomy device is a specialized tool designed to excise atherosclerotic plaque from peripheral arteries. It operates by using a rotating cutting blade or burr to shave away plaque, restoring blood flow. This device is crucial in managing peripheral artery disease, especially in patients with significant arterial blockages.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery settings. It is employed in procedures to treat peripheral artery disease, particularly in the lower extremities. Patients who benefit from this device often have symptoms of claudication or critical limb ischemia, and the procedure is typically performed in a catheterization lab or surgical suite.
Indications for Use
The device is indicated for patients with peripheral artery disease, where there is a need to remove plaque from arteries to improve blood flow. It is suitable for patients experiencing symptoms like leg pain due to arterial blockages.
Practical Considerations
Clinicians should consider the size of the artery and the extent of the plaque when selecting the appropriate device size. Compatibility with existing catheter systems is generally good, but always verify with the manufacturer's specifications. Proper technique is essential to minimize complications such as vessel perforation.
Frequently Asked Questions
What is the modified IVT peripheral atherectomy used for?
It is used to remove plaque from peripheral arteries to improve blood flow in patients with peripheral artery disease.
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 patients with peripheral artery disease requiring plaque removal to restore arterial 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.