Coils
Cerepak Heliform
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.
Cerepak Heliform 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 |
|---|---|---|---|
| SHD100154 | Length 190 cm; Length 4 cm | MR Conditional | Available |
| SHD100208 | Length 190 cm; Length 8 cm | MR Conditional | Available |
| SHD100250 | Length 190 cm; Length 10 cm | MR Conditional | Available |
| SHD100258 | Length 190 cm; Length 8 cm | MR Conditional | Available |
| SHD100308 | Length 190 cm; Length 8 cm | MR Conditional | Available |
| SHD100310 | Length 190 cm; Length 10 cm | MR Conditional | Available |
| SHD100408 | Length 190 cm; Length 8 cm | MR Conditional | Available |
| SHD100410 | Length 190 cm; Length 10 cm | MR Conditional | Available |
| SHD100510 | Length 190 cm; Length 10 cm | MR Conditional | Available |
| SHD100515 | Length 190 cm; Length 15 cm | MR Conditional | Available |
| SHD100612 | Length 190 cm; Length 12 cm | MR Conditional | Available |
| SHD100616 | Length 190 cm; Length 16 cm | MR Conditional | Available |
| SHD100716 | Length 190 cm; Length 16 cm | MR Conditional | Available |
| SHD100720 | Length 190 cm; Length 20 cm | MR Conditional | Available |
| SHD100820 | Length 190 cm; Length 20 cm | MR Conditional | Available |
| SHD100925 | Length 190 cm; Length 25 cm | MR Conditional | Available |
| SHD180312 | Length 190 cm; Length 12 cm | MR Conditional | Available |
| SHD180415 | Length 190 cm; Length 15 cm | MR Conditional | Available |
| SHD180520 | Length 190 cm; Length 20 cm | MR Conditional | Available |
| SHD180625 | Length 190 cm; Length 25 cm | MR Conditional | Available |
| SHD180733 | Length 190 cm; Length 33 cm | MR Conditional | Available |
| SHD180835 | Length 190 cm; Length 35 cm | MR Conditional | Available |
| SHD180935 | Length 190 cm; Length 35 cm | MR Conditional | Available |
| SHD181040 | Length 190 cm; Length 40 cm | MR Conditional | Available |
| SHD181242 | Length 190 cm; Length 42 cm | MR Conditional | Available |
| SHD181445 | Length 190 cm; Length 45 cm | MR Conditional | Available |
| SHD181650 | Length 190 cm; Length 50 cm | MR Conditional | Available |
| SHD181855 | Length 190 cm; Length 55 cm | MR Conditional | Available |
| SHD182060 | Length 190 cm; Length 60 cm | MR Conditional | Available |
| SHD182260 | Length 190 cm; Length 60 cm | MR Conditional | Available |
| SHD182460 | Length 190 cm; Length 60 cm | MR Conditional | Available |
| XHD100151 | Length 190 cm; Length 1 cm | MR Conditional | Available |
| XHD100152 | Length 190 cm; Length 2 cm | MR Conditional | Available |
| XHD100153 | Length 190 cm; Length 3 cm | MR Conditional | Available |
| XHD100201 | Length 190 cm; Length 1 cm | MR Conditional | Available |
| XHD100202 | Length 190 cm; Length 2 cm | MR Conditional | Available |
| XHD100203 | Length 190 cm; Length 3 cm | MR Conditional | Available |
| XHD100204 | Length 190 cm; Length 4 cm | MR Conditional | Available |
| XHD100206 | Length 190 cm; Length 6 cm | MR Conditional | Available |
| XHD100254 | Length 190 cm; Length 4 cm | MR Conditional | Available |
| XHD100256 | Length 190 cm; Length 6 cm | MR Conditional | Available |
| XHD100304 | Length 190 cm; Length 4 cm | MR Conditional | Available |
| XHD100306 | Length 190 cm; Length 6 cm | MR Conditional | Available |
| XHD100406 | Length 190 cm; Length 6 cm | MR Conditional | Available |
| XHD100408 | Length 190 cm; Length 8 cm | MR Conditional | Available |
| XHE120204 | Length 190 cm; Length 4 cm | MR Conditional | Available |
| XHE120206 | Length 190 cm; Length 6 cm | MR Conditional | Available |
| XHE120208 | Length 190 cm; Length 8 cm | MR Conditional | Available |
FDA clearances
- 510(k) K220040 July 2022
Procedures that use coils
Frequently asked questions
What is Cerepak Heliform 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 Cerepak Heliform?
Cerepak Heliform is made by Cerenovus, Inc.. It is listed under embolization coils in our device library.
What sizes does Cerepak Heliform come in?
Sizes listed for Cerepak Heliform: Length: 1–190 cm. Confirm availability with the manufacturer's instructions for use.
Is Cerepak Heliform MRI safe?
The FDA device database lists Cerepak Heliform as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Cerepak Heliform FDA cleared?
Cerepak Heliform is covered by FDA submission K220040.
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.