NeVa VS - H210004
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Probable Benefit (SSPB) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: NeVa VS
HDE Applicant: Vesalio
Address: 2305 Historic Decatur Road, Suite 100
San Diego, California 92106
Approval Date: September 9, 2022
Approval Letter: Approval order
What is it?
The NeVa VS is a self-expanding mesh stent intended to be used as an additional (adjunct) treatment when the brain’s blood vessels are narrowed (cerebral vasospasm) and causing clinical symptoms after a brain aneurysm causes bleeding into the cerebrospinal fluid around the brain (subarachnoid hemorrhage). The NeVa VS is made of nickel-titanium alloy (nitinol).
How does it work?
The NeVa VS is inserted in an artery through a small cut, usually in the groin, and then threaded through the blood vessels until it reaches the artery in the brain where the narrowed arteries are located. Once there, the stent is expanded against the walls of the blood vessel to widen (dilate) it. The stent and delivery system are removed once the vessel is widened.
When is it used?
The NeVa VS is approved for use in people aged 22 and older who have:
- Symptomatic cerebral vasospasm, defined as blood vessels narrowed by 50% or greater, confirmed by angiographic imaging, and decreased consciousness or brain, nerve, or spinal cord function (focal neurological deficit).
- Tried all available medical treatments to address their condition.
- Surgery to keep the brain aneurysm stable inside the skull.
It is indicated for use in the following arteries that carry blood to and in the brain:
- Internal carotid artery
- Middle cerebral artery
- Anterior cerebral artery
- Posterior cerebral artery
- Basilar artery
What will it accomplish?
The clinical results support the probable benefit of NeVa VS. In a single-arm clinical study of 30 people, 74 brain arteries were treated with the NeVa VS. In patients with serious symptoms unresponsive to all other available treatment, the diameter of some brain arteries that were constricted to 50% or less of their usual diameter increased to more than 50% after treatment. There was no way to accurately estimate any clinical benefits because there was no control group. NeVa VS may provide some benefit to this rare disease population with symptomatic cerebral artery vasospasm unresponsive to other available treatments.
When should it not be used?
The NeVa VS should not be used in patients with the following conditions:
- Aneurysm that has not been secured and has burst (ruptured)
- Sensitivity or allergy to any of the device’s parts, including nickel
- Suspected or known sensitivity to angiography contrast media
- Abnormalities in blood vessels (excessive vessel tortuosity) that prevent device placement
- Known blood disorders, such as a tendency for bleeding (hemorrhage), clotting problems (coagulation factor deficiency or oral anticoagulant therapy with international normalized ratio (INR) >1.7)
- Low levels of platelets in the blood (baseline platelets < 30,000)
- Evidence of rapidly improving neurological stroke symptoms
- A large completed stroke in the brain (cerebral infarction), swelling (edema) with mass effect, and bleeding in the functional parts of the blood vessels (intra-parenchymal hemorrhage) to be treated
Additional information (including warnings, precautions, and adverse events):