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edwards peripheral dilation catheter
Edwards Lifesciences
Summary: The Edwards Peripheral Dilation Catheter is a device used for dilating peripheral vessels. It is primarily used in venous stent procedures. Key evidence highlights its feasibility and safety in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K052149 ↗
Decision Date
September 2, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Edwards Peripheral Dilation Catheter was cleared by the FDA via the 510(k) pathway on September 2, 2005. It is manufactured by Edwards Lifesciences and classified as a Class 2 device.
What It Is
The Edwards Peripheral Dilation Catheter is designed to dilate peripheral vessels, facilitating the placement of venous stents. It is intended for use in vascular procedures to improve blood flow.
Clinical Applications
Commonly used in procedures involving venous stents, the catheter aids in the dilation of peripheral vessels. It is utilized in clinical scenarios requiring vessel expansion to optimize stent placement.
Evidence Summary
The literature includes 8 studies, comprising various study types such as RCTs and case series, spanning from 2017 to 2022. These studies evaluate the device's performance and safety.
Reported Outcomes
Published studies report that the Edwards Peripheral Dilation Catheter is effective in achieving vessel dilation necessary for venous stent placement. The device has shown feasibility in clinical settings, with successful outcomes in improving blood flow.
Safety Profile
Reported complications include potential vessel injury and embolic events, although these are infrequent. The studies highlight the importance of careful procedural technique to minimize risks.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up in some studies. Further research is needed to establish comprehensive safety profiles and long-term efficacy.
Frequently Asked Questions
What are the clinical indications for Edwards Peripheral Dilation Catheter?
The device is indicated for use in procedures requiring dilation of peripheral vessels, particularly in the placement of venous stents.
What outcomes have been reported in clinical studies?
Studies have reported successful vessel dilation and improved blood flow, demonstrating the device's effectiveness in clinical settings.
What complications have been reported?
Safety data indicate potential complications such as vessel injury and embolic events, though these are rare with proper technique.
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.