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modification to polarcath peripheral dilatation system
Boston Scientific
Summary: The Polarcath Peripheral Dilatation System by Boston Scientific is a medical device used for dilating peripheral blood vessels. It is primarily used by interventional radiologists and vascular surgeons to treat conditions such as peripheral artery disease.
FDA Clearance Information
Pathway
510K
Number
K060572 ↗
Decision Date
March 15, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Polarcath Peripheral Dilatation System was cleared through the FDA 510(k) pathway on March 15, 2006. Manufactured by Boston Scientific, it is classified as a Class 2 device under product code DQY.
What It Is
The Polarcath Peripheral Dilatation System is a medical device designed to dilate peripheral blood vessels. It utilizes a specialized balloon catheter that can be inserted into the vascular system to widen narrowed or obstructed blood vessels. This device aids in improving blood flow and is particularly useful in treating peripheral artery disease, where plaque buildup restricts blood flow in the arteries.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures aimed at treating peripheral artery disease, particularly in the legs, where blood flow needs to be restored. Patients who benefit from this device typically have symptoms of claudication or critical limb ischemia. The device is used in hospitals and specialized outpatient centers equipped for vascular interventions.
Indications for Use
The FDA indications for the Polarcath Peripheral Dilatation System include the treatment of peripheral artery disease by dilating narrowed or blocked peripheral blood vessels. It is intended for patients with conditions that cause reduced blood flow to the limbs, often resulting in pain or risk of tissue damage.
Practical Considerations
The Polarcath system comes in various sizes to accommodate different vessel diameters, ensuring compatibility with a range of patient anatomies. Clinicians should be familiar with the device's insertion and inflation techniques to maximize its efficacy and minimize complications. Proper imaging guidance is essential during the procedure to ensure accurate placement and dilation.
Frequently Asked Questions
What is the Polarcath Peripheral Dilatation System used for?
It is used to dilate narrowed or blocked peripheral blood vessels, improving blood flow in patients with peripheral artery disease.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their practice.
What are the FDA-cleared indications?
The device is indicated for dilating peripheral blood vessels in patients with peripheral artery disease to improve blood flow and alleviate symptoms.
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.