📋 FDA Reference
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 ?
510(k)
Number ?
K896403 ↗
Decision Date ?
March 6, 1990
Product Code ?
LIT Catheter, Angioplasty, Peripheral, Transluminal
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.
FDA-Cleared Indications
- Removal of atherosclerotic plaque from peripheral arteries in patients with peripheral vascular disease.
- Use during a percutaneous transluminal angioplasty procedure to treat obstructive disease in peripheral arteries.
Clinical Applications
- Catheter-based plaque removal in peripheral arteries affected by peripheral artery disease.
- Treatment of arterial blockages in the legs when an endovascular approach is selected.
- Use with peripheral transluminal angioplasty equipment during minimally invasive vascular procedures.
Practical Considerations
- The device is available in sizes intended for different peripheral artery diameters; selection should follow the device labeling and vessel measurements.
- It is used with fluoroscopic imaging and standard catheterization equipment by clinicians trained in peripheral endovascular procedures.
- Careful advancement, positioning and plaque removal are required to reduce the risk of vessel injury, dissection, perforation or distal embolization.
- The available FDA record does not establish MRI safety; MRI conditions should be confirmed in the current labeling before scanning a patient with the device in place.
- Contraindications, access-site requirements, anticoagulation and use with adjunctive angioplasty should be determined from the current instructions for use and the patient's vascular anatomy.
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.