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echomark csi interface
Catheter Sciences
Summary: The Echomark CSI Interface is a medical device used for guiding catheters during procedures using ultrasound. It is primarily used by interventional radiologists and cardiologists for precise catheter placement.
FDA Clearance Information
Pathway
510K
Number
K910965 ↗
Decision Date
September 17, 1991
Product Code
LIT
Device Class
Class 2
Evidence
0 studies
The Echomark CSI Interface was cleared through the FDA 510(k) pathway on September 17, 1991. It is manufactured by Catheter Sciences and is classified as a Class 2 device.
What It Is
The Echomark CSI Interface is a catheter system interface designed to enhance the guidance of catheters using ultrasound imaging. It integrates an ultrasound sensor into the catheter, allowing clinicians to visualize the catheter's position in real-time. This technology improves the accuracy of catheter placement by providing a visual marker on ultrasound images.
Clinical Applications
This device is commonly used in interventional radiology and cardiology, particularly during angioplasty procedures. It is beneficial in settings where precise catheter placement is critical, such as in the treatment of vascular occlusions or during tumor ablation procedures. The device is suitable for adult patients requiring minimally invasive interventions.
Indications for Use
The Echomark CSI Interface is indicated for use in procedures requiring precise catheter guidance, such as angioplasty or tumor ablation. It is designed to assist clinicians in accurately positioning catheters using ultrasound imaging.
Practical Considerations
The Echomark CSI Interface is compatible with standard ultrasound equipment and catheters. Clinicians should ensure proper calibration of the ultrasound system to optimize the visualization of the catheter's position. Typical sizing considerations depend on the specific catheter used in conjunction with the interface.
Related Literature
The linked study, 'Principles of angioplasty guidance using ultrasound,' explored the use of ultrasound for guiding catheters during angioplasty. It highlighted the integration of an ultrasound sensor within the catheter to provide real-time positioning via a bright arrow on ultrasound images. The study demonstrated initial clinical success but noted the need for further research to validate the technology's efficacy across broader clinical settings.
Frequently Asked Questions
What is Echomark CSI Interface used for?
The Echomark CSI Interface is used for guiding catheters during procedures using ultrasound imaging, enhancing precision in catheter placement.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device during procedures such as angioplasty and tumor ablation.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring precise catheter guidance, such as angioplasty or tumor ablation, using ultrasound imaging.
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.