Coils
Orbit Galaxy Enpower
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.
Orbit Galaxy Enpower 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 |
|---|---|---|---|
| 641CF0201 | Length 1.5 cm; Length 190 cm | MR Conditional | Available |
| 641CF0202 | Length 2 cm; Length 190 cm | MR Conditional | Available |
| 641CF0304 | Length 4 cm; Length 190 cm | MR Conditional | Available |
| 641CF0306 | Length 6 cm; Length 190 cm | MR Conditional | Available |
| 641CF0308 | Length 8 cm; Length 190 cm | MR Conditional | Available |
| 641CF0407 | Length 7 cm; Length 190 cm | MR Conditional | Available |
| 641CF0410 | Length 10 cm; Length 190 cm | MR Conditional | Available |
| 641CF0412 | Length 12 cm; Length 190 cm | MR Conditional | Available |
| 641CF0510 | Length 10 cm; Length 190 cm | MR Conditional | Available |
| 641CF0515 | Length 15 cm; Length 190 cm | MR Conditional | Available |
| 641CF0615 | Length 15 cm; Length 190 cm | MR Conditional | Available |
| 641CF0620 | Length 20 cm; Length 190 cm | MR Conditional | Available |
| 641CF0715 | Length 15 cm; Length 190 cm | MR Conditional | Available |
| 641CF0721 | Length 21 cm; Length 190 cm | MR Conditional | Available |
| 641CF0815 | Length 15 cm; Length 190 cm | MR Conditional | Available |
| 641CF0824 | Length 24 cm; Length 190 cm | MR Conditional | Available |
| 641CF0925 | Length 25 cm; Length 190 cm | MR Conditional | Available |
| 641CF1030 | Length 30 cm; Length 190 cm | MR Conditional | Available |
| 641CF1230 | Length 30 cm; Length 190 cm | MR Conditional | Available |
| 641CF2505 | Length 5 cm; Length 190 cm | MR Conditional | Available |
| 641CF2535 | Length 3.5 cm; Length 190 cm | MR Conditional | Available |
| 641CF3509 | Length 9 cm; Length 190 cm | MR Conditional | Available |
| 641CF3575 | Length 7.5 cm; Length 190 cm | MR Conditional | Available |
FDA clearances
- 510(k) K142429 December 2014
Procedures that use coils
Frequently asked questions
What is Orbit Galaxy Enpower 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 Orbit Galaxy Enpower?
Orbit Galaxy Enpower is made by Medos International Sàrl. It is listed under embolization coils in our device library.
What sizes does Orbit Galaxy Enpower come in?
Sizes listed for Orbit Galaxy Enpower: Length: 1.5–190 cm. Confirm availability with the manufacturer's instructions for use.
Is Orbit Galaxy Enpower MRI safe?
The FDA device database lists Orbit Galaxy Enpower as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Orbit Galaxy Enpower FDA cleared?
Orbit Galaxy Enpower is covered by FDA submission K142429.
How do I contact a Medos International Sàrl sales representative?
Medos International Sàrl has not listed representatives on LA Vascular yet. Visit the Medos International Sàrl 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.