📊 Evidence-Based Reference
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 ?
510(k)
Number ?
K885237 ↗
Decision Date ?
March 16, 1989
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter intended for selective infusion within the vascular system.
- Use by qualified clinicians for catheter-based delivery of fluids or therapeutic agents to a selected vascular location.
Clinical Applications
- Selective catheterization and infusion during an endovascular vascular procedure.
- Delivery of a physician-selected infusion to a targeted vessel or vascular region.
- Use as part of catheter-based treatment in peripheral or central venous interventions when consistent with the device labeling.
Reported off-label uses
- Selective intra-arterial infusion in interventional cardiology or peripheral vascular procedures may be reported for catheter types in this category, but use must be evaluated against the original labeling and institutional policy.
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 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.
Practical Considerations
- The supplied FDA record does not specify the catheter's available lengths, French sizes, lumen dimensions, guidewire compatibility, or maximum injection pressure; these details should be obtained from the original labeling or manufacturer documentation.
- Use requires appropriate vascular access, imaging guidance, sterile technique, and monitoring for complications such as bleeding, vessel injury, thrombosis, infection, embolization, or contrast reaction.
- MRI safety is not established by the information provided. Confirm the exact catheter model and its MR labeling before entering an MRI environment.
- The catheter should not be used when the required vascular access cannot be safely obtained or when the intended infusion is contraindicated; medication-specific contraindications also apply.
- The device is intended for procedural use rather than long-term implantation. Inspect the package and catheter before use and follow the labeled instructions for flushing, handling, and disposal.
Procedures that use this device
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.