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edwards peripheral dilatation catheter
Edwards Lifesciences
Summary: The Edwards Peripheral Dilatation Catheter is a medical device used for dilating peripheral vessels. It is primarily used in venous stent procedures. Key evidence highlights its application in various vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K032587 ↗
Decision Date
October 2, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Edwards Peripheral Dilatation Catheter was cleared by the FDA through the 510(k) pathway on October 2, 2003. It is manufactured by Edwards Lifesciences and classified as a Class 2 medical device.
What It Is
The Edwards Peripheral Dilatation Catheter is designed to dilate peripheral blood vessels. It is used in clinical settings to facilitate the placement of stents or to improve blood flow in narrowed or obstructed vessels.
Clinical Applications
This catheter is commonly used in procedures involving venous stents, particularly in cases where vessel dilation is required to ensure proper stent placement or to alleviate vascular obstructions.
Evidence Summary
The available literature includes 8 studies, comprising various study types such as RCTs, case series, and retrospective analyses. These studies span from 2017 to 2022, providing insights into the device's clinical applications.
Reported Outcomes
Published studies report that the Edwards Peripheral Dilatation Catheter is effective in achieving vessel dilation, facilitating successful stent placement, and improving blood flow in treated vessels. The outcomes indicate a high rate of procedural success in vascular interventions.
Safety Profile
Reported complications include potential risks associated with vascular interventions, such as vessel injury or bleeding. However, the studies reviewed did not highlight any significant safety concerns specific to the catheter itself.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term outcomes and to compare its efficacy with other similar devices.
Frequently Asked Questions
What are the clinical indications for Edwards Peripheral Dilatation Catheter?
The catheter is indicated for use in procedures requiring vessel dilation, particularly in the placement of venous stents and treatment of vascular obstructions.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful vessel dilation and improved blood flow, with high procedural success rates in vascular interventions.
What complications have been reported?
Safety data from evidence indicate potential complications such as vessel injury or bleeding, though no significant device-specific safety concerns were noted.
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.