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scorpion portal vein access set
Argon Medical Devices
Summary: The Scorpion Portal Vein Access Set is a medical device used for gaining access to the portal vein, primarily in interventional radiology. It is utilized by clinicians for procedures involving portal vein embolization.
FDA Clearance Information
Pathway
510K
Number
K213002 ↗
Decision Date
October 14, 2021
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Scorpion Portal Vein Access Set was cleared through the FDA 510(k) pathway on October 14, 2021. It is manufactured by Argon Medical Devices and classified as a Class 2 device under product code DYB.
What It Is
The Scorpion Portal Vein Access Set is designed to facilitate access to the portal vein, which is crucial in procedures such as portal vein embolization. The device typically includes a needle and catheter system that allows for precise entry into the portal vein. This access is vital for both diagnostic and therapeutic interventions in the hepatic system.
Clinical Applications
This device is commonly used in interventional radiology, particularly in procedures involving liver disease where portal vein access is necessary. It is often employed in pre-surgical planning for liver resections or transplants. The device is used in hospital settings, primarily by interventional radiologists and hepatologists, for adult patients with conditions affecting the liver.
Indications for Use
The Scorpion Portal Vein Access Set is indicated for use in patients requiring portal vein access, often those undergoing procedures like portal vein embolization. This is typically relevant for patients with liver tumors or those needing pre-operative planning for liver surgery.
Practical Considerations
The device is typically available in various sizes to accommodate different patient anatomies. Clinicians should ensure compatibility with other interventional tools and be familiar with the technique for safe and effective use. Proper training in ultrasound or fluoroscopic guidance is recommended for optimal results.
Related Literature
The Achieving Portal Access With Scorpion Post-Approval Study (APASS) aimed to evaluate the effectiveness and safety of the Scorpion Portal Vein Access Set post-clearance. Although specific findings are not available, such studies typically assess procedural success rates and complication rates. Limitations include the lack of available data and potential variability in operator technique.
Frequently Asked Questions
What is the Scorpion Portal Vein Access Set used for?
It is used for gaining access to the portal vein, primarily in procedures like portal vein embolization.
What specialties typically use this device?
Interventional radiologists and hepatologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for portal vein access in patients undergoing procedures such as portal vein embolization.
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.