📊 Evidence-Based Reference
Tracker Infusion Catheter
Target Therapeutics
Summary: The tracker infusion catheter by Target Therapeutics is a Class 2 medical device cleared by the FDA for use in venous stents. Key evidence highlights its application in enhancing drug delivery and managing complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K862117 ↗
Decision Date ?
October 1, 1986
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The tracker infusion catheter was cleared through the FDA 510k pathway on October 1, 1986. It is manufactured by Target Therapeutics and classified as a Class 2 device under product code DQY.
What It Is
The tracker infusion catheter is designed for precise drug delivery within venous stents. It facilitates targeted infusion, improving therapeutic outcomes in vascular interventions.
FDA-Cleared Indications
- Use as a percutaneous catheter for intravascular access and administration of fluids or therapeutic agents, consistent with the device labeling.
- Use under imaging guidance in vascular procedures when catheter-based delivery is clinically indicated.
Clinical Applications
- Catheter-based delivery of a therapeutic agent within a blood vessel.
- Percutaneous vascular access during diagnostic or interventional procedures.
- Selective catheterization of a target vessel when directed delivery is required.
Evidence Summary
The literature includes 11 studies, encompassing RCTs, prospective, and retrospective analyses from 1997 to 2021. These studies explore the catheter's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report improved drug delivery accuracy and enhanced therapeutic outcomes in vascular and oncological applications. The catheter's use in chemotherapy and blood-brain barrier disruption has shown promising results.
Safety Profile
Reported complications include limitations in mobility due to device placement and potential for hematoma formation post-procedure. Overall, the safety profile is favorable with low complication rates.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to explore the catheter's efficacy in diverse patient populations and settings.
Practical Considerations
- The available record does not provide the catheter's French sizes, length options, lumen configuration, guidewire compatibility, or maximum injection pressure; these should be verified in the original instructions for use.
- Use requires appropriate vascular access, sterile technique, and imaging guidance. Catheter selection should match the target vessel, access route, and intended infusion.
- Potential complications of percutaneous intravascular catheterization include bleeding, hematoma, vascular injury, thrombosis, infection, embolization, and contrast-related reactions.
- MRI safety cannot be determined from the supplied FDA record. Check the current device labeling before MRI or use near an MRI system.
- Do not use when the catheter, infusion agent, access route, or planned procedure is contraindicated; review allergies, coagulation status, renal function when contrast is planned, and relevant vascular anatomy.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for tracker infusion catheter?
The device is indicated for use in venous stents and targeted drug delivery, particularly in vascular and oncological interventions.
What outcomes have been reported in clinical studies?
Studies have reported improved drug delivery accuracy and enhanced therapeutic outcomes, particularly in chemotherapy and vascular interventions.
What complications have been reported?
Safety data indicates potential complications such as limited mobility due to device placement and hematoma formation, though overall complication rates are low.
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.