Vesalio Announces CE Mark Approval for NeVa VS and NeVa 3.0 mm

February 10, 2026—Vesalio announced CE Mark certification and the European commercial launch of its NeVa VS for cerebral vasospasm after aneurysmal subarachnoid hemorrhage (aSAH) and NeVa 3.0 mm thrombectomy system for stroke, along with an additional FDA 510(k) clearance expanding indications for its neurovascular and peripheral aspiration catheters to include distal access, according to the company’s press release.

NeVa VS is intended for the treatment of cerebral vasospasm after aSAH. The device previously received FDA approval under a humanitarian device exemption and is positioned as an alternative to balloon angioplasty. The company said NeVa VS is designed to preserve distal blood flow while treating critically narrowed vessels. Data from the VITAL study showed that 93.2% of treated vessels required no further intervention in refractory vasospasm.

“I use NeVa VS regularly—it’s safe, more controlled, and preserves flow where traditional angioplasty cannot,” said Ameer Hassan, MD, of Harlingen, Texas, in the release. “We’ve seen exceptional clinical outcomes with no recurrence of vasospasm in some very critical cases.”

The NeVa 3.0 mm thrombectomy system also received CE Mark certification, extending Vesalio’s Drop Zone technology to smaller, more tortuous cerebral arteries. The company said the device expands the NeVa stroke portfolio by enabling mechanical thrombectomy in patients who may not have been candidates for larger-bore systems, while maintaining the platform’s all-clot capability and reported high first-pass success.

“NeVa 3.0 mm is a welcome addition to the Vesalio stroke portfolio,” said Roland Schwab, MD, of Magdeburg, Germany, in the press release. “I look forward to evaluating its impact in cases where NeVa was previously not an option.”

Separately, the FDA 510(k) clearance expands the labeled indications for Vesalio’s neurovascular and peripheral aspiration catheters to include distal access with microcatheter delivery.