Vesalio Expands International Neurovascular Portfolio with CE Mark of NeVa VS and NeVa 3.0 mm and Receives Additional FDA 510(k) Clearance for its Aspiration Catheters

Company advances global neuro-intervention footprint with new CE-marked devices for vasospasm and stroke, and expanded U.S. indications for aspiration catheters.

PLANO, Texas, Feb. 10, 2026 /PRNewswire/ -- Vesalio, a global leader in vascular intervention, today announced CE Mark certification and the European commercial launch of two new neurovascular devices: NeVa^™ VS, for the treatment of cerebral vasospasm following aneurysmal subarachnoid hemorrhage (aSAH), and the NeVa^™ 3.0 mm Thrombectomy System for stroke. In addition, the Company received an additional U.S. Food and Drug Administration (FDA) 510(k) clearance expanding the indications of its neurovascular and peripheral aspiration catheters to include distal access.

"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.

"I use NeVa VS regularly—it's safe, more controlled, and preserves flow where traditional angioplasty cannot," said Dr. Ameer Hassan, Harlingen, Texas, U.S. "We've seen exceptional clinical outcomes with no recurrence of vasospasm in some very critical cases." 

Also receiving CE Mark certification, the NeVa 3.0 mm Thrombectomy device extends Vesalio's proprietary Drop Zone^™ technology to smaller, more tortuous arteries. This expansion broadens Vesalio's stroke treatment portfolio and increases the number of patients who may be eligible for mechanical thrombectomy using the NeVa platform. NeVa 3.0 mm delivers NeVa's proven all-clot capability and high first-pass success² to a broader patient population.

"3.0 mm NeVa is a welcome addition to the Vesalio stroke portfolio," said Dr. Roland Schwab, Interventional Neuroradiologist, Magdeburg, Germany. "I look forward to evaluating its impact in cases where NeVa was previously not an option."

In addition, Vesalio received 510(k) clearance from the FDA, expanding the labeled indications for its neurovascular and peripheral aspiration catheters to include distal access with microcatheter delivery, further enhancing the versatility of the company's catheter portfolio across neurovascular and peripheral interventions.

"These milestones reflect Vesalio's continued drive to expand access to our technologies globally," stated Steve Rybka, Chief Executive Officer of Vesalio. "They highlight the breadth and adaptability of our portfolio as well as position Vesalio to advance to the next phase of our commercial growth following the regulatory clearances achieved late last year."

About Vesalio:
Founded in 2017, Vesalio is a privately held medical device company focused on advancing patient care in thromboembolic vascular disease. Its proprietary NeVa^™, enVast^™, and pVasc^™ platforms are designed to remove all types of clots and restore vital blood flow to compromised ischemic tissue in the brain, heart, and peripheral anatomy. Vesalio's products have treated more than 15,000 patients in over 60 countries. For more information, visit www.vesalio.com.

Investor Contacts:
Steve Rybka, CEO, Vesalio
[email protected]

J.D. McCulloch, CFO, Vesalio
[email protected]

References:
1. Gupta R, Woodward K, Fiorella D, et al. Primary results of the Vesalio NeVa VS for the Treatment of Symptomatic Cerebral Vasospasm following Aneurysm Subarachnoid Hemorrhage (VITAL) Study. Journal of Neurointerventional Surgery. 2022;14(8):815-819. doi:https://doi.org/10.1136/neurintsurg-2021-017859
2. Yoo AJ, Geyik S., Froehler MT, et al. Primary results from the CLEAR study of a novel stent retriever with drop zone technology. Journal of NeuroInterventional Surgery. Published online December 2, 2023:jnis-020960. doi:https://doi.org/10.1136/jnis-2023-020960

SOURCE Vesalio