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modified ivt peripheral atherectomy system
Intensive Technology
Summary: The Modified IVT Peripheral Atherectomy System is a medical device used to remove plaque from peripheral arteries. It is primarily used by interventional cardiologists and vascular surgeons to treat peripheral artery disease (PAD).
FDA Clearance Information
Pathway
510K
Number
K896403 ↗
Decision Date
March 6, 1990
Product Code
LIT
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on March 6, 1990, by Intensive Technology. It is classified as a Class 2 medical device under product code LIT.
What It Is
The Modified IVT Peripheral Atherectomy System is designed to excise atherosclerotic plaque from peripheral arteries. It utilizes a rotating cutting mechanism to shave plaque from the arterial walls, improving blood flow. This device is typically used in minimally invasive procedures, offering an alternative to more invasive surgical options.
Clinical Applications
This device is commonly used in the treatment of peripheral artery disease (PAD), particularly in patients with significant arterial blockages in the legs. It is often employed in outpatient settings or catheterization labs by interventional cardiologists or vascular surgeons. The device is suitable for patients who are not ideal candidates for open surgery due to comorbid conditions.
Indications for Use
The FDA indications suggest this device is intended for patients with peripheral artery disease requiring plaque removal to restore blood flow. It is particularly useful in cases where traditional surgical options are not feasible.
Practical Considerations
The device comes in various sizes to accommodate different arterial diameters. It is compatible with standard catheterization equipment and requires specific technique training for optimal use. Clinicians should ensure proper sizing and handle the device with care to avoid arterial damage.
Frequently Asked Questions
What is the Modified IVT Peripheral Atherectomy System used for?
It is used to remove atherosclerotic 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 in the treatment of peripheral artery disease.
What are the FDA-cleared indications?
The device is indicated for the removal of plaque in peripheral arteries to treat peripheral artery disease, especially in patients unsuitable for open surgery.
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.