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Pantheris Lv Atherectomy Catheter
Product: Pantheris LV — all models and sizes
Summary: The Pantheris LV Atherectomy Catheter is a medical device used for removing plaque from blood vessels. It is primarily used by vascular surgeons and interventional cardiologists to treat peripheral artery disease.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K230005 ↗
Decision Date ?
June 6, 2023
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
1 studies
The Pantheris LV Atherectomy Catheter by Avinger was cleared through the FDA 510(k) pathway on June 6, 2023. It is a Class 2 device under product code MCW.
What It Is
The Pantheris LV Atherectomy Catheter is a minimally invasive device designed to excise and remove plaque from the interior of blood vessels. It combines directional atherectomy with real-time intravascular imaging to enhance precision during procedures. This device is particularly useful in treating peripheral artery disease by restoring blood flow in occluded or narrowed arteries.
FDA-Cleared Indications
- Removal of plaque from peripheral arteries in patients with peripheral artery disease.
- Directional atherectomy treatment of peripheral arterial lesions to help restore or improve blood flow.
- Use in peripheral vessels that meet the catheter's labeled size and anatomical requirements.
Clinical Applications
- Image-guided atherectomy of plaque in peripheral lower-extremity arteries.
- Treatment of symptomatic peripheral artery disease when plaque removal and revascularization are clinically appropriate.
- Debulking a peripheral arterial lesion before or during an endovascular revascularization procedure.
- Use by trained clinicians in a catheter-based procedure performed through vascular access.
Practical Considerations
- The catheter is available in configurations intended for specific peripheral vessel diameters and lesion locations; clinicians should follow the current instructions for use.
- The device is used over a compatible guidewire and requires fluoroscopic guidance with intravascular imaging during plaque removal.
- Access is commonly obtained through a peripheral artery, such as the common femoral artery, although the access approach depends on the treatment plan and anatomy.
- Atherectomy can cause embolization, dissection, perforation, thrombosis, bleeding, or the need for additional angioplasty, stenting, or surgery.
- MRI safety depends on the specific device and whether it remains in the patient; the current labeling should be checked before MRI. The catheter is generally a single-use device and is not intended for long-term implantation.
Linked Studies (1)
PubMed • 2018
Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Pantheris LV Atherectomy Catheter used for?
It is used for removing plaque from blood vessels in patients with peripheral artery disease to improve blood flow.
What specialties typically use this device?
Vascular surgeons and interventional cardiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for the removal of plaque in patients with peripheral artery disease to restore 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.