Stent Retrievers
NeVa VS
Indications for Use
The NeVa VS is indicated for use as an adjunct treatment for symptomatic cerebral vasospasm in the internal carotid artery (ICA), middle cerebral artery (MCA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), or basilar artery caused by aneurysmal subarachnoid hemorrhage in adults 22 years of age or older who have exhausted maximal medical treatment and have had the intracranial aneurysm secured by either surgical or endovascular intervention. Symptomatic cerebral vasospasm is defined as more than 50% narrowing of the indicated cerebral vessels confirmed by angiographic imaging and a decreased level of consciousness or a focal neurological deficit.
Key Specifications
- Temporary use, self-expanding, nitinol stent-like device
- Percutaneously introduced via microcatheter with minimum internal diameter of 0.021 inches
- Includes nitinol push wire
- Deploys in M1 and M2 branches of MCA, intracranial ICA, basilar artery, ACA, and P1 PCA
- Labeled device diameter: 4.0 mm
- Labeled device length: 22 mm
- Self-expanded device diameter: 4.0 mm
- Recommended pre-vasospasm vessel diameter: 2.0-3.5 mm
- Pusher length: 180 cm
- Sterile and intended for single-use only
- Materials include nitinol and stainless steel components
- Sterilized using gamma radiation to SAL of 10-6
- Endotoxin specification: < 2.15 EU per device
Description
The NeVa VS is a temporary use, self-expanding, nitinol, stent-like, percutaneously introduced transluminal cerebral artery dilatation device. It includes a nitinol push wire delivered through a commercially available microcatheter with a minimum internal diameter of 0.021 inches. When deployed, the tip expands to apply radial forces to dilate the target vessel. It can be deployed in specified cerebral arteries. The device is provided sterile and intended for single-use only.