📊 Evidence-Based Reference
Edwards Peripheral Dilatation Catheter
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 ?
510(k)
Number ?
K032587 ↗
Decision Date ?
October 2, 2003
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous dilation of peripheral blood vessels.
- Dilation of stenotic or obstructed peripheral vessels when balloon angioplasty is clinically indicated.
- Use during endovascular procedures in which vessel enlargement is needed to facilitate treatment.
Clinical Applications
- Balloon dilation of narrowed peripheral veins or arteries.
- Vessel preparation before placement of a peripheral vascular stent.
- Post-dilation of a peripheral stent when additional expansion is needed.
- Treatment of a peripheral vascular narrowing or obstruction by percutaneous balloon angioplasty.
Reported off-label uses
- Balloon dilation during venous stenting procedures in anatomy or situations not specifically described in the device labeling.
- Adjunctive vessel dilation during selected endovascular treatments for deep vein thrombosis.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The catheter size, balloon diameter, balloon length and rated pressure must match the target vessel and the planned procedure.
- Use requires compatible guidewires, introducer sheaths and inflation equipment according to the device instructions for use.
- The catheter is advanced under fluoroscopic or other appropriate imaging guidance, with careful control of balloon inflation and deflation.
- MRI safety depends on the specific catheter model and its labeling; a device should not be considered MRI safe without confirming the applicable instructions for use.
- Potential complications include vessel dissection, perforation, thrombosis, embolization, bleeding, infection and restenosis. Contraindications and precautions should be reviewed in the current manufacturer labeling.
Procedures that use this device
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.