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modification to pathway pv atherectomy system
Pathway Medical Technologies
Summary: The Modification to Pathway PV Atherectomy System is a medical device used for atherectomy procedures to remove plaque from blood vessels. It is typically used by vascular surgeons and interventional cardiologists.
FDA Clearance Information
Pathway
510K
Number
K082186 ↗
Decision Date
August 29, 2008
Product Code
MCW
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on August 29, 2008. It is manufactured by Pathway Medical Technologies and classified as a Class 2 device under product code MCW.
What It Is
The Modification to Pathway PV Atherectomy System is a specialized device designed to perform atherectomy, a minimally invasive procedure to remove atherosclerotic plaque from peripheral blood vessels. It works by using a rotating cutting mechanism to shave and remove plaque, thereby restoring blood flow. This device is particularly useful in treating peripheral artery disease (PAD) and is designed to enhance precision and safety during the procedure.
Clinical Applications
This device is commonly used in clinical settings such as hospitals and outpatient surgical centers, primarily by vascular surgeons and interventional cardiologists. It is used in procedures to treat peripheral artery disease, particularly in patients with significant plaque buildup in their peripheral arteries. The device is suitable for use in adult patients who present with symptoms of PAD, such as claudication or critical limb ischemia.
Indications for Use
The FDA indications suggest that this device is intended for use in patients with peripheral artery disease to remove plaque from their arteries. It is suitable for patients who require restoration of blood flow due to significant arterial blockages.
Practical Considerations
Clinicians should consider the size and compatibility of the device with the patient's anatomy when planning the procedure. Proper technique is crucial to ensure effective plaque removal and to minimize the risk of complications. Familiarity with the device's operation and maintenance is essential for optimal outcomes.
Frequently Asked Questions
What is the Modification to Pathway PV Atherectomy System used for?
It is used for removing atherosclerotic plaque from peripheral arteries to restore blood flow in patients with peripheral artery disease.
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 use in removing plaque from peripheral arteries in patients with peripheral artery disease.
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.