đź“‹ FDA Reference
modification to polarcath peripheral dilatation system
Cryo Vascular Systems
Summary: The Polarcath Peripheral Dilatation System is a medical device used for dilating peripheral blood vessels. It is primarily used by interventional radiologists and vascular surgeons to treat conditions like peripheral artery disease.
FDA Clearance Information
Pathway
510K
Number
K042541 ↗
Decision Date
October 12, 2004
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Polarcath Peripheral Dilatation System received FDA clearance through the 510(k) pathway on October 12, 2004. It is manufactured by Cryo Vascular Systems and is classified as a Class 2 device.
What It Is
The Polarcath Peripheral Dilatation System is designed to dilate or expand peripheral blood vessels using a cryoplasty technique. This involves cooling the vessel wall during balloon angioplasty, which may reduce restenosis rates. The device is typically used in minimally invasive procedures to improve blood flow in patients with peripheral artery disease.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in treating patients with peripheral artery disease, a condition that affects blood flow to the limbs. The device is employed in outpatient settings or hospitals where endovascular procedures are performed, and it is suitable for adult patients experiencing symptoms of reduced blood flow.
Indications for Use
The FDA indications suggest that the device is used for dilating peripheral blood vessels, particularly in patients with conditions like peripheral artery disease. It is intended for use in patients who require improved blood flow in their peripheral arteries.
Practical Considerations
The Polarcath system typically comes in various balloon sizes to accommodate different vessel diameters. It is compatible with standard guidewires and catheters used in peripheral interventions. Clinicians should be familiar with cryoplasty techniques and consider vessel size and lesion characteristics when selecting the appropriate balloon size.
Frequently Asked Questions
What is the Polarcath Peripheral Dilatation System used for?
It is used to dilate peripheral blood vessels, improving blood flow in conditions like peripheral artery disease.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for dilating peripheral blood vessels in patients with conditions such as 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.