đź“‹ FDA Reference
pantheris lv atherectomy catheter
Avinger
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
510K
Number
K230005 ↗
Decision Date
June 6, 2023
Product Code
MCW
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.
Clinical Applications
This device is commonly used in the treatment of peripheral artery disease (PAD), particularly in patients with significant plaque buildup in the lower extremities. Vascular surgeons and interventional cardiologists use it in hospital settings or outpatient surgical centers. It is suitable for patients who are symptomatic and require revascularization to alleviate symptoms like claudication or critical limb ischemia.
Indications for Use
The Pantheris LV Atherectomy Catheter is indicated for patients with peripheral artery disease who have significant plaque accumulation in their arteries. It is used to remove this plaque and improve blood flow, thereby reducing symptoms and preventing complications.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters and is compatible with standard guidewires and catheters. Clinicians should be trained in atherectomy techniques and familiar with the use of intravascular imaging for optimal outcomes.
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.