Accell EVO3 Formerly Accell A2I
Integra Life Sciences
FDA Clearance Information
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
FDA-Cleared Indications
- Embolization of hypervascular tumors and other lesions when blocking their blood supply is clinically indicated.
- Embolization of arteriovenous malformations and other abnormal vascular structures.
- Occlusion of selected blood vessels during minimally invasive embolization procedures.
Clinical Applications
- Image-guided embolization of abnormal or hypervascular vessels.
- Embolization of selected tumors to reduce or block their blood supply.
- Embolization of arteriovenous malformations and similar vascular lesions.
- Catheter-based occlusion of targeted vessels when temporary or permanent reduction of blood flow is needed.
Reported off-label uses
- Embolization for uterine fibroids is a well-established clinical use of embolic microspheres, but the specific FDA labeling for this device should be reviewed before use.
- Embolization of selected bleeding vessels or other vascular conditions may be reported for microspheres in clinical practice, depending on the device labeling and clinical circumstances.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The microspheres are available in different size ranges; the selected size should match the target vessel, blood-flow characteristics, and intended level of occlusion.
- The device is delivered through a compatible catheter under fluoroscopic or other appropriate imaging guidance. Catheter compatibility and particle handling instructions should be confirmed before the procedure.
- Embolization requires careful angiographic assessment to reduce the risk of non-target embolization, vessel injury, ischemia, or unintended blockage of vessels supplying normal tissue.
- Contraindications, warnings, particle preparation, and maximum injection volumes should be checked in the current manufacturer instructions for use.
- MRI safety depends on the device materials and current labeling; the product-specific MRI status should be verified rather than assumed.
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.