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occlusion perfusion catheter
Advanced Catheter Therapies
Summary: The occlusion perfusion catheter by Advanced Catheter Therapies is a device used for targeted drug delivery in vascular interventions. Key evidence highlights its role in delivering antiproliferative agents to prevent restenosis.
FDA Clearance Information
Pathway
510K
Number
K130525 ↗
Decision Date
October 3, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The occlusion perfusion catheter was cleared by the FDA through the 510(k) pathway on October 3, 2013. It is manufactured by Advanced Catheter Therapies and classified as a Class 2 device.
What It Is
The occlusion perfusion catheter is a medical device designed to deliver therapeutic agents directly to the arterial wall. It is primarily used in endovascular procedures to treat peripheral arterial disease by inhibiting restenosis.
Clinical Applications
Commonly used in the treatment of peripheral arterial disease, the occlusion perfusion catheter is applied in scenarios requiring localized drug delivery to prevent arterial restenosis, particularly in infrapopliteal lesions.
Evidence Summary
The literature includes 10 studies, comprising RCTs, prospective, and retrospective analyses, published between 2018 and 2024. These studies explore the catheter's efficacy in drug delivery and its potential to improve vascular outcomes.
Reported Outcomes
Published studies report that the occlusion perfusion catheter effectively delivers antiproliferative agents like paclitaxel to the arterial wall, reducing restenosis rates. The device has shown promise in enhancing drug delivery precision and improving vascular healing.
Safety Profile
Reported complications include potential delays in vascular healing due to non-specific drug targeting. However, cell-targeted therapies using the catheter may mitigate these concerns by focusing on vascular smooth muscle cells.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term outcome data. Further research is needed to confirm the catheter's efficacy and safety in diverse patient populations and over extended follow-up periods.
Frequently Asked Questions
What are the clinical indications for the occlusion perfusion catheter?
The device is indicated for the localized delivery of therapeutic agents to treat peripheral arterial disease and prevent restenosis.
What outcomes have been reported in clinical studies?
Studies have shown effective delivery of antiproliferative agents, reducing restenosis rates and improving drug delivery precision.
What complications have been reported?
Safety data indicate potential delays in vascular healing, though targeted therapies may reduce these risks.
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.