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accell evo3 formerly accell a2i
Integra Life Sciences
Summary: The accell evo3, formerly known as accell a2i, is a medical device used in embolization procedures. It is primarily utilized by interventional radiologists to treat various conditions involving abnormal blood vessels.
FDA Clearance Information
Pathway
510K
Number
K103742 ↗
Decision Date
March 17, 2011
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
The accell evo3 was cleared through the FDA 510(k) pathway on March 17, 2011. Manufactured by Integra Life Sciences, it is classified as a Class 2 device under product code MBP.
What It Is
The accell evo3 is a type of embolization microsphere used in minimally invasive procedures to block blood flow to specific areas. This device is designed to occlude blood vessels, which can be beneficial in treating conditions like arteriovenous malformations or tumors by depriving them of their blood supply. The microspheres are delivered via a catheter, allowing precise targeting of the affected vessels.
Clinical Applications
The accell evo3 is commonly used in interventional radiology, particularly for embolization procedures. It is employed in settings such as hospitals and specialized clinics, where procedures are performed to manage conditions like uterine fibroids, liver tumors, or vascular malformations. The device is suitable for adult patients requiring targeted embolization to control abnormal blood flow or reduce tumor size.
Indications for Use
The FDA-cleared indications for the accell evo3 involve its use in embolization procedures to block blood flow in abnormal vessels. This can be particularly useful for patients with conditions such as tumors or vascular malformations that benefit from reduced blood supply.
Practical Considerations
The accell evo3 microspheres come in various sizes to accommodate different vessel diameters, ensuring effective occlusion. Clinicians should consider the compatibility of the microspheres with the delivery catheter and the specific technique required for precise placement. Proper imaging guidance is crucial for successful outcomes.
Frequently Asked Questions
What is accell evo3 used for?
The accell evo3 is used for embolization procedures to block blood flow in abnormal vessels, often in the treatment of tumors or vascular malformations.
What specialties typically use this device?
Interventional radiologists primarily use the accell evo3 in procedures requiring embolization.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to occlude blood vessels in conditions like tumors or vascular malformations.
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.