Vesalio has broadened its neurovascular portfolio after securing CE mark certification for two newly developed products, further advancing the company’s neurovascular devices from Vesalio in the European market. The approvals cover NeVa VS and NeVa 3.0 mm.
The CE mark for NeVa VS introduces an alternative treatment option for cerebral vasospasm following aneurysmal subarachnoid hemorrhage. Cerebral vasospasm occurs when blood vessels in the brain become narrowed and constricted, typically in the days or weeks after a ruptured brain aneurysm (subarachnoid hemorrhage). This narrowing can significantly restrict oxygen delivery to brain tissue, increasing the risk of brain damage and, in severe cases, death without timely intervention.
NeVa VS is a novel self-expanding, retractable nitinol-based cerebral dilation device that preserves distal blood flow while treating the narrowed vessels. Its braided stent architecture reinforces vessel integrity while maintaining continuous circulation, positioning it as a safer alternative to balloon angioplasty. Early clinical data showed 93.2% of NeVa VS-treated vessels required no further intervention.
The device has already gained FDA approval under a Humanitarian Device Exemption.
Alongside NeVa VS, Vesalio also received CE mark certification for NeVa 3.0 mm. This stent builds on Vesalio’s patented neuro thrombectomy technology and is specifically designed to address smaller, more tortuous arteries.
Vesalio’s NeVa stent portfolio is engineered to retrieve blood clots in a single pass by entrapping and securing the clot within one of three braided net sections. This approach differs from traditional endovascular thrombectomy methods that penetrate the clot, pin it, and drag it along the artery wall for removal.
NeVa 3.0 mm enables clot retrieval in arteries as small as 1.5 mm, expanding the number of patients who may be eligible for mechanical thrombectomy.
“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 Vesalio VP of Market Development, Diane Demet Tangun.
Following CE mark certification, Vesalio confirmed the European commercial launch of NeVa VS and NeVa 3.0 mm, further strengthening its portfolio of neurovascular devices from Vesalio available in the region.
Separately, the company also obtained 510(k) clearance to expand indications to include distal access with microcatheter delivery in its neurovascular and peripheral aspiration catheters. Distal access with microcatheter delivery can help improve visualization of brain aneurysms hidden by adjacent arteries or branches.