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rist 071 radial access guide catheter
Micro Therapeutics Inc., D/B/A Ev3 Neurovascular
Summary: The rist 071 radial access guide catheter is a medical device used for vascular access, particularly in neurovascular procedures. It is typically used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K211990 ↗
Decision Date
July 27, 2021
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The rist 071 radial access guide catheter was cleared through the FDA 510(k) pathway on July 27, 2021. It is manufactured by Micro Therapeutics Inc., operating as Ev3 Neurovascular, and is classified as a Class 2 device.
What It Is
The rist 071 radial access guide catheter is designed for radial artery access, facilitating the delivery of interventional devices to the neurovascular system. Its design supports minimally invasive procedures, offering an alternative to femoral access. The catheter's flexibility and compatibility with various embolic materials make it suitable for complex vascular interventions.
Clinical Applications
This device is commonly used in neurovascular interventions, such as embolization procedures for conditions like chronic subdural hematoma. It is particularly useful in patients where transradial access is preferred, such as those with challenging femoral access or specific anatomical considerations. The device is utilized in hospital settings by specialists in interventional radiology and neurosurgery.
Indications for Use
The FDA indications for the rist 071 radial access guide catheter include its use in facilitating access to the vascular system for the delivery of therapeutic devices. It is particularly indicated for patients requiring neurovascular interventions.
Practical Considerations
The rist 071 catheter is available in various sizes to accommodate different patient anatomies. It is compatible with a range of embolic agents, such as Onyx, and requires careful handling to ensure successful navigation through the vascular system. Clinicians should be familiar with radial access techniques to optimize outcomes.
Related Literature
A study titled 'Transradial middle meningeal artery embolization for chronic subdural hematoma using Onyx' explored the use of the rist 071 catheter in a case series. The study found that transradial access for MMA embolization was effective in treating chronic subdural hematoma, particularly in elderly patients with comorbidities. However, the study was limited by its small sample size and lack of a control group.
Frequently Asked Questions
What is the rist 071 radial access guide catheter used for?
It is used for vascular access in neurovascular procedures, facilitating the delivery of therapeutic devices.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for facilitating access to the vascular system for neurovascular interventions.
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.