Vesalio has 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 haemorrhage (aSAH) and the Neva 3mm thrombectomy system for stroke. The company has also received an additional US 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 specialised solutions for complex vascular conditions and to supporting physicians with technologies designed for real-world clinical challenges.”
Neva VS has been designed to address a “critical unmet need” in the management of cerebral vasospasm following aSAH, according to a recent press release from Vesalio. Already US FDA-approved under a humanitarian device exemption (HDE), it is said to offer a safer alternative to balloon angioplasty, with the added advantage of preserving distal blood flow while treating critically narrowed vessels.
The release goes on to state that clinical data from the VITAL study 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,” commented Ameer Hassan (Valley Baptist Medical System, Harlingen, USA). “We’ve seen exceptional clinical outcomes with no recurrence of vasospasm in some very critical cases.”
The Neva 3mm thrombectomy device—now also CE-mark certified—extends Vesalio’s proprietary Drop Zone technology to smaller, more tortuous arteries, the company states, going on to detail that this expansion broadens its stroke treatment portfolio and increases the number of patients who may be eligible for mechanical thrombectomy using the Neva platform. The 3mm device can deliver Neva’s “proven all-clot capability” and high first-pass success seen in within the CLEAR study to a broader patient population.
“[The] 3mm Neva is a welcome addition to the Vesalio stroke portfolio,” said Roland Schwab (University Hospital Magdeburg, Magdeburg, Germany). “I look forward to evaluating its impact in cases where Neva was previously not an option.”
Furthermore, Vesalio recently received 510(k) clearance from the US FDA, expanding the labelled 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, the release adds.
“These milestones reflect Vesalio’s continued drive to expand access to our technologies globally,” commented Steve Rybka, chief executive officer (CEO) 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.”
