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introducer for ptca guiding catheters
Argon Medical
Summary: The introducer for PTCA guiding catheters by Argon Medical is used in percutaneous coronary interventions. Key evidence highlights its use in minimizing arterial access size and improving procedural outcomes.
FDA Clearance Information
Pathway
510K
Number
K891022 ↗
Decision Date
May 19, 1989
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on May 19, 1989, by Argon Medical. It is classified as a Class 2 device under product code DYB.
What It Is
This device is an introducer for PTCA guiding catheters, designed to facilitate the insertion of catheters during percutaneous coronary interventions. It is intended to minimize arterial trauma and improve procedural efficiency.
Clinical Applications
Commonly used in scenarios requiring percutaneous coronary interventions, particularly where minimizing arterial access size is crucial. It is applicable in both transradial and transfemoral approaches.
Evidence Summary
The literature includes 10 studies, comprising RCTs, prospective, retrospective, and case series, published between 2011 and 2021. These studies explore various techniques and outcomes associated with the device.
Reported Outcomes
Published studies report that the device facilitates smaller arterial access without compromising the working lumen, potentially reducing complications associated with larger sheaths. It is effective in both transradial and transfemoral interventions.
Safety Profile
Reported complications include potential radial injury and challenges in crossing certain arterial segments. However, the device's design aims to mitigate these risks by reducing the outer diameter of the introducer.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to explore the device's efficacy in diverse patient populations and complex clinical scenarios.
Frequently Asked Questions
What are the clinical indications for introducer for PTCA guiding catheters?
The device is indicated for use in percutaneous coronary interventions to facilitate catheter insertion while minimizing arterial trauma.
What outcomes have been reported in clinical studies?
Studies report effective reduction in arterial access size and improved procedural outcomes without compromising catheter functionality.
What complications have been reported?
Safety data indicate potential radial injury and difficulties in crossing certain arterial segments, though these are mitigated by the device's design.
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.