📋 FDA Reference
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 ?
510(k)
Number ?
K901767 ↗
Decision Date ?
June 28, 1990
Product Code ?
LIT Catheter, Angioplasty, Peripheral, Transluminal
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.
FDA-Cleared Indications
- Removal or reduction of atherosclerotic plaque in peripheral arteries.
- Treatment of peripheral arterial stenosis or occlusion when plaque removal is clinically indicated.
- Use during a peripheral transluminal angioplasty procedure to improve arterial blood flow.
Clinical Applications
- Atherectomy of plaque in peripheral lower-extremity arteries.
- Treatment of peripheral arterial blockages causing symptoms such as exertional leg pain.
- Plaque removal before or with balloon angioplasty when additional luminal treatment is needed.
- Endovascular treatment performed in a catheterization laboratory or vascular procedure suite.
Practical Considerations
- Select the device size and configuration according to the target vessel diameter, lesion characteristics, and manufacturer labeling.
- Confirm compatibility with the guidewire, catheter, sheath, and other equipment used for the procedure.
- Use fluoroscopic imaging and careful advancement to reduce the risk of dissection, perforation, distal embolization, or vessel injury.
- MRI safety cannot be determined from the available FDA record; review the current device labeling before MRI exposure.
- Contraindications and precautions should be based on the original manufacturer instructions, including factors such as unsuitable vessel anatomy, inability to cross the lesion, active infection, or uncorrected bleeding risk.
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.