Coils
Trufill
A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
Trufill models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 633-000 | — | Not stated | Available |
| 633-010 | — | Not stated | Available |
| 633-120 | — | Not stated | Available |
| 633-140 | — | Not stated | Available |
| 633-160 | — | Not stated | Available |
| 633-320 | — | Not stated | Available |
| 633-330 | — | Not stated | Available |
| 633-340 | — | Not stated | Available |
| 633-350 | — | Not stated | Available |
| 633-360 | — | Not stated | Available |
| 633-370 | — | Not stated | Available |
| 635-002 | — | Not stated | Available |
FDA clearances
- 510(k) K123560 January 2013
Procedures that use coils
Frequently asked questions
What is Trufill used for?
A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
Who makes Trufill?
Trufill is made by Cerenovus, Inc.. It is listed under embolization coils, liquid embolic agents in our device library.
What sizes does Trufill come in?
The FDA device database does not list sizes for Trufill. Check the instructions for use or ask a Cerenovus, Inc. representative.
Is Trufill MRI safe?
The FDA device database entry for Trufill does not state its MRI safety status. Check the labeling before MRI.
Is Trufill FDA cleared?
Trufill is covered by FDA submission K123560.
How do I contact a Cerenovus, Inc. sales representative?
Cerenovus, Inc. has not listed representatives on LA Vascular yet. Visit the Cerenovus, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.