Vesalio expanded its neurovascular portfolio after earning CE mark certification for two new devices: NeVa VS and Neva 3.0 mm. The first of Vesalio’s CE marks, NeVa VS, offers an alternative treatment for cerebral vasospasm following aneurysmal subarachnoid hemorrhage.
Cerebral vasospasm causes blood vessels in the brain to become narrow and constricted, often occurring in the days or weeks following a ruptured brain aneurysm (subarachnoid hemorrhage). The narrowing can reduce the amount of oxygen that reaches the brain and cause brain damage and sometimes death without intervention.
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NeVa VS is a novel self-expanding, retractable nitinol-based cerebral dilation device that preserves distal blood flow while treating the narrowed vessels. The stent’s design strengthens the vessel’s structure and allows for continuous blood flow, providing 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.
Vesalio also announced CE marks for NeVa 3.0 mm, a stent which builds on Vesalio’s patented neuro thrombectomy technology to treat smaller, more tortuous arteries.
Vesalio’s NeVa stent portfolio is designed to retrieve blood clots in a single pass by entrapping and securing the clot within one of three braided net sections. The stent differs from the traditional endovascular thrombectomy methods that penetrate the clot, pin and drag it along the artery wall for removal.
NeVa 3.0 mm retrieves blood clots in arteries as small as 1.5 mm, increasing the number of patients who might 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 announced NeVa VS and NeVa 3.0 mm’s European commercial launch.
Vesalio also received 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.
