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coronary infusion catheter
Advanced Cardiovascular Systems
Summary: The coronary infusion catheter by Advanced Cardiovascular Systems is used for local drug delivery in coronary interventions. Key evidence highlights its role in reducing restenosis rates with heparin delivery.
FDA Clearance Information
Pathway
510K
Number
K831717 ↗
Decision Date
June 30, 1983
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The coronary infusion catheter was cleared through the FDA 510(k) pathway on June 30, 1983. Manufactured by Advanced Cardiovascular Systems, it is classified as a Class 2 device.
What It Is
The coronary infusion catheter is designed for the localized delivery of therapeutic agents directly into coronary arteries. It is primarily used in interventional cardiology to deliver drugs like heparin to prevent restenosis.
Clinical Applications
Commonly used in procedures requiring targeted drug delivery to coronary arteries, such as during or after angioplasty, to prevent restenosis or treat thrombus formation.
Evidence Summary
The literature includes 10 studies, comprising randomized controlled trials and case series, spanning from 1994 to 2019. These studies explore the catheter's efficacy in drug delivery for coronary interventions.
Reported Outcomes
Published studies report that local heparin delivery using the coronary infusion catheter can reduce target vessel revascularization rates to 28.26%. However, other studies, such as those involving S-dC28, did not show significant prevention of restenosis.
Safety Profile
Reported complications include a 19.15% incidence of ischemia and one reported death occurring six days post-intervention. These highlight the need for careful patient monitoring during and after procedures.
Evidence Limitations
The evidence is limited by small sample sizes and variability in study designs. Further research is needed to confirm long-term efficacy and safety across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for coronary infusion catheter?
The device is indicated for local drug delivery in coronary arteries, particularly to prevent restenosis post-angioplasty.
What outcomes have been reported in clinical studies?
Studies have shown a reduction in target vessel revascularization rates with heparin delivery, though not all agents tested have been effective.
What complications have been reported?
Safety data indicate a 19.15% incidence of ischemia and a case of post-procedural death, necessitating careful monitoring.
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.