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super distal access sda
Inneuro
Summary: The Super Distal Access (SDA) catheter by Inneuro is used in endovascular procedures to treat acute ischemic stroke. It is primarily utilized by interventional radiologists and neurologists.
FDA Clearance Information
Pathway
510K
Number
K161262 ↗
Decision Date
September 19, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Super Distal Access SDA catheter received FDA clearance through the 510(k) pathway on September 19, 2016. It is manufactured by Inneuro and classified as a Class 2 device under product code DQY.
What It Is
The Super Distal Access SDA catheter is a large bore cerebral aspiration catheter designed for endovascular procedures. It facilitates the removal of thrombi from cerebral arteries, particularly in cases of acute ischemic stroke. The device's design allows for enhanced navigation and access to distal cerebral vasculature, making it a valuable tool in neurointerventional procedures.
Clinical Applications
The SDA catheter is commonly used in the treatment of acute ischemic stroke, especially in the anterior circulation. It is employed in neurointerventional settings by specialists such as interventional radiologists and neurologists. The device is particularly useful in hospitals with comprehensive stroke centers where rapid intervention is critical for patient outcomes.
Indications for Use
The FDA indications for the SDA catheter include its use in endovascular procedures to treat acute ischemic stroke. It is intended for patients experiencing blockages in the cerebral arteries, where timely removal of the clot can significantly impact recovery.
Practical Considerations
The SDA catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard endovascular equipment, and clinicians should be familiar with catheter navigation techniques to optimize its use.
Related Literature
The linked study evaluated the performance of the Syphontrack Super Distal Access catheter in treating acute ischemic stroke. Initial results demonstrated its effectiveness in accessing and aspirating thrombi in the anterior circulation. However, the study was limited by its small sample size and lack of long-term outcome data.
Frequently Asked Questions
What is the Super Distal Access SDA used for?
The SDA is used for endovascular treatment of acute ischemic stroke by facilitating thrombus removal from cerebral arteries.
What specialties typically use this device?
Interventional radiologists and neurologists commonly use this device in neurointerventional procedures.
What are the FDA-cleared indications?
The SDA is indicated for use in endovascular procedures to treat acute ischemic stroke by removing blockages in cerebral arteries.
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.