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acs selective infusion catheter
Advanced Cardiovascular Systems
Summary: The ACS Selective Infusion Catheter by Advanced Cardiovascular Systems is used in vascular interventions, primarily for selective infusion in venous stents. Key evidence highlights its role in improving perfusion in acute coronary syndromes.
FDA Clearance Information
Pathway
510K
Number
K885237 ↗
Decision Date
March 16, 1989
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ACS Selective Infusion Catheter was cleared by the FDA via the 510(k) pathway on March 16, 1989. It is manufactured by Advanced Cardiovascular Systems and classified as a Class 2 device.
What It Is
The ACS Selective Infusion Catheter is a medical device designed for selective infusion in vascular procedures. It is primarily used in the context of venous stents to deliver therapeutic agents directly to targeted areas.
Clinical Applications
This catheter is commonly used in interventional radiology and cardiology, particularly in procedures involving the treatment of acute coronary syndromes and no-reflow phenomena. It facilitates targeted delivery of medications to improve vascular outcomes.
Evidence Summary
The available literature includes three studies, primarily from 2010 to 2019, encompassing various study designs such as RCTs and case series. These studies explore the catheter's efficacy in improving coronary perfusion and reducing thrombus formation.
Reported Outcomes
Published studies report that the ACS Selective Infusion Catheter is effective in improving myocardial perfusion and reducing thrombus burden in acute coronary syndromes. It has shown promise in addressing the no-reflow phenomenon during percutaneous coronary interventions.
Safety Profile
Reported complications include the potential for vascular injury and local adverse reactions at the infusion site. However, the studies provided do not extensively detail the safety profile, indicating a need for further investigation.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to fully understand the long-term safety and efficacy of the device in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for ACS Selective Infusion Catheter?
The catheter is indicated for use in vascular interventions, particularly in treating acute coronary syndromes and managing no-reflow phenomena.
What outcomes have been reported in clinical studies?
Studies have reported improved myocardial perfusion and reduced thrombus burden in patients with acute coronary syndromes.
What complications have been reported?
Reported complications include potential vascular injury and local adverse reactions at the infusion site.
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.