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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 ?
510(k)
Number ?
K130525 ↗
Decision Date ?
October 3, 2013
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- The FDA record classifies the device as a percutaneous catheter under 21 CFR 870.1250.
- The supplied FDA indications field contains only the word “Statement,” so a more specific FDA-cleared indication cannot be confirmed from the available record.
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.
Reported off-label uses
- Localized delivery of antiproliferative medication during selected peripheral vascular interventions has been described for catheter systems of this type.
- Use in targeted drug delivery for peripheral arterial lesions has been reported in clinical practice and literature, but the specific indication should be confirmed against the device labeling and institutional protocols.
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 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.
Practical Considerations
- Use requires vascular access, guidewire or catheter compatibility, and fluoroscopic imaging; exact compatible sizes and delivery specifications must be confirmed in the current instructions for use.
- The balloon or occlusion segment temporarily reduces blood flow, so operators must assess distal perfusion, treatment duration, and the risk of ischemia.
- Potential complications include vascular injury, thrombosis, embolization, dissection, perforation, bleeding at the access site, infection, and medication-related effects.
- MRI safety, conditional status, and any restrictions depend on the exact device and components; consult the current manufacturer labeling rather than assuming MRI compatibility.
- The device is intended for single-use vascular procedures unless the current labeling states otherwise; it is not an implant designed to remain in the body.
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.