“These approvals mark our seventh CE certification and reflect the continued growth and strategic refinement of Vesalio’s neurovascular portfolio on a global scale,” said Diane Demet Tangun, Vice President of Market Development at Vesalio. “They reinforce our commitment to delivering specialized solutions for complex vascular conditions and to supporting physicians with technologies designed for real-world clinical challenges.”
NeVa VS addresses a critical unmet need in the management of cerebral vasospasm following aSAH—a serious and potentially life-threatening condition associated with delayed cerebral ischemia and neurological decline. Already FDA approved under a Humanitarian Device Exemption (HDE), NeVa VS offers a safer alternative to balloon angioplasty, with the added advantage of preserving distal blood flow while treating critically narrowed vessels. Clinical data from the VITAL study1 demonstrate strong performance in refractory vasospasm, with 93.2% of treated vessels requiring no further intervention, supporting NeVa VS as a potential definitive therapeutic option.