Coils
Nitinol Enhanced Device
A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
Nitinol Enhanced Device 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 |
|---|---|---|---|
| N3F-2300 | — | MR Conditional | Available |
| N3F-3400 | — | MR Conditional | Available |
| N3F-4500 | — | MR Conditional | Available |
| N3P-0023 | — | MR Conditional | Available |
| N3P-0035 | — | MR Conditional | Available |
Procedures that use coils
Frequently asked questions
What is Nitinol Enhanced Device used for?
A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; 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 Nitinol Enhanced Device?
Nitinol Enhanced Device is made by Embolization Inc.. It is listed under embolization coils in our device library.
What sizes does Nitinol Enhanced Device come in?
The FDA device database does not list sizes for Nitinol Enhanced Device. Check the instructions for use or ask a Embolization Inc. representative.
Is Nitinol Enhanced Device MRI safe?
The FDA device database lists Nitinol Enhanced Device as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Nitinol Enhanced Device FDA cleared?
Nitinol Enhanced Device is registered in the FDA's Global Unique Device Identification Database (GUDID).
How do I contact a Embolization Inc. sales representative?
Embolization Inc. has not listed representatives on LA Vascular yet. Visit the Embolization 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.